doi 10.1515/jcim-2014-0002
J Complement Integr Med. 2014; 11(2): 129–137
Nagesh Bhat, Ruchi Mitra*, Swapnil Oza, Vinayak Kumar Mantu, Sharda Bishnoi, Mandeepsinh Gohil and Rupam Gupta
The antiplaque effect of herbal mouthwash in comparison to chlorhexidine in human gingival disease: a randomized placebo controlled clinical trial Abstract Background: The aim of this study was to compare the efficacy, safety, antiplaque and antigingivitis properties of a herbal mouthwash with chlorhexidine mouthwash. Methods: A double-blinded randomized clinical trial was conducted among 72 undergraduate students with age group 18–24 years. They were randomly divided into three mouthwash group with 24 participants in each group. Group A (herbal), Group B (chlorhexidine) and Group C (normal saline).The Turesky et al. 1970 plaque index and Loe and Silness 1963 gingival index was recorded. Student’s t-test and one-way ANOVA were used to test the significance. Results: A statistically highly significant difference was obtained between mouthwash B and C (p ¼ 0.00) and a significant difference between mouthwash A and C (p ¼ 0.004), showing that chlorhexidine was superior to herbal mouthwash and saline. However, there was a nonsignificant difference between mouthwash A and B (p ¼ 0.435) showing that herbal and chlorhexidine mouthwash was equally effective in reducing plaque and gingivitis. Conclusions: The efficacy of herbal mouthwash was equally effective in reducing plaque and gingivitis as compared to chlorhexidine mouthwash and may be considered as a good alternative. The chlorhexidine mouthwash was reported with many side effects which limits its acceptability and long-term use, whereas the presently tested herbal mouthwash had no side effects apart from mild burning sensation. Keywords: chlorhexidine, gingivitis, gingival index, herbal, plaque, plaque index
*Corresponding author: Ruchi Mitra, Department of Public Health Dentistry, Darshan Dental College and Hospital, Loyara, Udaipur 313011, Rajasthan, India, E-mail: [email protected] Nagesh Bhat, Swapnil Oza, Department of Public Health Dentistry, Darshan Dental College and Hospital, Loyara, Udaipur 313011, Rajasthan, India
Vinayak Kumar Mantu, Department of Oral and Maxillofacial Pathology, Darshan Dental College and Hospital, Loyara, Udaipur 313011, Rajasthan, India Sharda Bishnoi, Mandeepsinh Gohil, Rupam Gupta, Department of Public Health Dentistry, Darshan Dental College and Hospital, Loyara, Udaipur 313011, Rajasthan, India
Introduction Dental plaque is a film of microorganisms found on the tooth surface embedded in a matrix of polymers of salivary and bacterial origin. Dental plaque develops naturally on tooth surface and forms part of host defences of the oral cavity by acting as a barrier to colonization by exogenous microorganisms [1]. The gram-positive and gram-negative bacteria that compose oral biofilms produce many metabolites that induce gingivitis [2]. Dental plaque has been proved by extensive research by Harold Loe in 1965 [3] to be paramount factor in initiation and progression of gingival and periodontal diseases. A direct relationship has been demonstrated between plaque levels and the severity of gingivitis. Since plaque is the principal causative factor in gingival and periodontal diseases, the most rational methodology towards the prevention of periodontal diseases would be regular effective removal of plaque by personal oral hygiene [3] Supragingival plaque control is largely the responsibility of the individual, using tooth brushes and interdental cleaning devices. The majority of the population may not perform mechanical plaque removal sufficiently. Thus, antimicrobial mouthrinses that augment daily home care may provide an effective means of removing or controlling bacterial plaque to limit gingivitis and periodontitis [4]. The incorporation of chemical agents with antiplaque or antimicrobial activity into dental products has been proposed as a potential prophylactic method of reducing plaque-mediated conditions. A number of chemical agents
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which have antiseptic or antimicrobial action have been used, with variable success, to inhibit supragingival plaque formation and the development of gingivitis. Several chemical antiplaque agents have been tested but none has shown equal or better results than chlorhexidine without eliciting unfavourable side effects [5, 6]. In order to overcome such side effects, the World Health Organization (WHO) advice researchers to investigate the possible use of natural products such as herb and plant extracts. Plants and naturally derived products from plants have been used to enhance health and have been used for medicinal purposes for thousands of year. Most herbal supplements have been utilized for centuries based on empirical and testimonial support for their efficacy. Development in alternative medicine research has led to many mouthrinses and toothpastes based on plant extracts [4]. A number of clinical studies have shown the effects of using mouth washes extracted from herbs such as Sanguinarina, Myrtus communis, Quercus infectoria, Capparis spinosa and Cinnamon in the prevention of dental plaque accumulation [7, 8]. Recently, a herbal mouthwash has been introduced in clinical practice, which consists of the extracts of Salvadora persica, Terminalia bellerica, Piper betle, essential oils namely Gaultheria fragrantissima, Elettaria cardamomum, flavouring agents Mentha and Trachyspermum ammi. The natural herb S. persica is a medicinal plant whose roots have been used by many people in Africa, South America, Middle East and Asia. The precise method for use of Miswak was recorded by Babylonian 5000 B.C. and the fashion ultimately spread throughout the Greek and Romanian empire. S. persica has anticariogenic and antiplaque effects [9]. P. betle and E. cardamomum have antibiotic action. T. bellerica is an anti-inflammatory and immunity booster. Also, Mentha and T. ammi which are naturally flavouring agents prevent halitosis. The widespread use of mouthwashes as an aid to oral hygiene is a relatively recent phenomenon in the developing countries of the world. Also, the cost-effectiveness of the herbal mouthwash is less as compared to other commercially available chemical-based mouthwashes. Hence, herbal dental products are becoming popular among general public. The in vitro studies conducted on the efficacy of the herbal mouthwash suggest that the herbal mouthwash may be used as compared to chlorhexidine mouthwash. Hence clinical trials are being conducted to see the efficacy of herbal mouthwash in the oral cavity. In this study, an attempt was made to compare the efficacy on plaque, safety
and antigingivitis properties of a herbal mouthwash with chlorhexidine mouthwash among the study participants.
Materials and methods Study population The present study was a double-blinded, parallel designed randomized clinical trial carried out in the Department of Public Health Dentistry, Darshan Dental College and Hospital, Udaipur, Rajasthan, India. It included a total of 72 undergraduate students (37 males and 35 females in the age group of 18–24 years). The ethical clearance was obtained from the Ethical Review Committee of the institution and a written informed consent was obtained from the study participants after explaining in detail about the study.
Inclusion criteria The dental students with age group of 18–24 years, students willing to participate and with dentition of ≥20 teeth and a minimum of 5 teeth per quadrant, no relevant medical history and no periodontal treatment during past 3 months were included.
Exclusion criteria Students with orthodontic appliances or severe misaligned teeth, receiving antibiotic therapy or medication within past 6 months, presence of any systemic illness, subjects availing oral prophylaxis since past 6 months and students unable to comply with study appointment schedule were excluded.
Test solutions Group A (Herbal Mouthwash) Hiora® mouthwash (Himalaya Drug Company, Bangalore, India). Each gram of herbal mouthwash contains extracts of Pilu (S. persica) 5.0 mg, Bibhitaka (T. bellerica) 10.0 mg, Nagavalli (P. betle) 10.0 mg, oils Gandhapura taila (G. fragrantissima) 1.2 mg, Ela (E. cardamomum) 0.2 mg, flavouring agents Peppermint satva (Mentha spp.) 1.6 mg and Yavani satva (Trachyspermum ammi) 0.4 mg.
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Bhat et al.: Antiplaque effect of herbal and chlorhexidine mouthwash
Group B (Chlorhexidine Mouthwash) ClohexPlus® mouthwash (Dr Reddy’s Lab Ltd. Hyderabad, India) containing 0.20% w/v chlorhexidine was used in the present study. Group C (Normal Saline) Nirlife® mouthwash (Inven Pharmaceuticals Pvt. Ltd.; Dhar, Madhya Pradesh, India) containing 0.05% saline was used in the present study. Normal saline was coloured to resemble the mouthwashes.
Study design In order to check the feasibility and validity of the study, a pilot study was carried out. It also meant to assess the acceptability and regularity of using these mouthwashes. From the pilot study, it was found that the overall prevalence of plaque and gingivitis was 80%. Considering for the dropouts logistic and technical problems the sample size was inflated by 20%, hence the sample size was 72 with 24 participants in each group. A self-designed pretested proforma which consisted of three parts: First demographic information like name, age, sex and informed written consent. Second part gingival index and plaque index recorded at baseline and after 1month trial. The third part a questionnaire related to the complaints or discomfort like pain, burning sensation/ itching, dryness of mouth, taste disturbance and discoloration of teeth if any. The assignment of the participants to the groups and the codes to the product was done by a person not involved in the examination. All the subjects were provided with their assigned mouthrinses and were divided into Group A, Group B and Group C randomly using simple lottery method with 24 participants in each group. All the mouthrinses were dispensed in the identical bottles and thereby ensuring a total subject masking. The examiner and the participants were also blinded with regard to the mouthrinse allocated to them thereby ensuring a double-blinded study. Subjects were provided with measuring cups of 10 mL and were instructed to use 10 mL of mouthwash for 1 min carried out twice a day after tooth brushing for a period of 4 weeks (1 month). The gingival index Loe and Silness 1963 and Turesky–Gilmore–Glickman 1970 modification of Quigley–Hein plaque index were used to record the efficacy before rinsing (at baseline) and after 1 month. Prior to the start of the study training and calibration was done in order to check the feasibility and reliability of the study. The Kappa statistical analysis for interexaminer variability for Turesky et al. plaque index and Loe and Silness gingival index was 0.89 and 0.97, whereas the
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intraexaminer was 0.90 and 0.94 respectively showing high degree of conformity in observational judgment. All recordings were made by a single examiner. Plaque was assessed on the labial, buccal and lingual surfaces of all teeth after using disclosing agent (Two-tone dye). The severity of gingivitis was scored by examining the tissues surrounding each tooth that were divided into four gingival scoring units: distal-facial papilla, facial margin, mesial-facial papilla and the entire lingual gingival margin. All the participants were instructed to follow their routine oral hygiene practices along with the assigned regimen and to maintain a reminder sheet on daily product use. Each one of the daily rinses was supervised on each weekday and also supervised by a daily recall message for reminding them to use the assigned mouthwash. The compliance was checked with the help of a reminder sheet by the examiner during surprise recall of the participants. Also, the participants were recalled along with the mouthwash bottles assigned to check for the mouthwash volume used by the participants.
Statistical analysis The obtained data were compiled systematically. Data collected were coded, computerized and analyzed using Statistical package for Social Sciences (SPSS version 17.0). One-way ANOVA and Student’s t-test were used to compare the means of plaque and gingival index values between the three mouthwashes.
Results The study participants were selected according to the inclusion and exclusion criteria. A total of 72 students participated in the study out of which 37 were males and 35 were females with 24 students in each group in the beginning of the study. However, two students did not report after 1 month in spite of several recalls, three students were irregular in using mouthwash found during surprise visit and one of the students became ill and had to quit the study due to antibiotic coverage. Hence, a total of 66 students participated of which 32 were females and 34 were males with 22 students in each group. The mean age for herbal group, chlorhexidine group and saline group was 20.2 0.7, 20.95 .1 and 20.79±1.2 respectively. There was statistically no significant difference (p ¼ 0.356) in the mean age of herbal (Group A), chlorhexidine (Group B) and saline groups (Group C).
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Table 1
Bhat et al.: Antiplaque effect of herbal and chlorhexidine mouthwash
Comparison among the three mouthwashes on plaque index using one-way ANOVA. Prerinsing PI (Baseline)
Source of variation
df
Sum of squares
Mean square
F-Value
Between groups A, B, C Within groups Total
2 63 65
0.068 4.23 4.29
0.032 0.023
0.052
p-Value 0.87 (NSa)
Postrinsing PI Source of variation
df
Between groups A, B, C Within groups Total
2 63 65
Sum of squares 8.51 8.76 17.26
Mean square 4.29 0.14
F-Value
p-Value 0.000 (HSb)
30.62
a
NS, statistically non significant; bHS, statistically highly significant.
Table 2
Comparison among the three mouthwashes on gingival index using one-way ANOVA. Prerinsing (Baseline)
Source of variation
df
Sum of squares
Mean square
Between groups A, B, C Within groups Total
2 63 65
0.006 2.54 2.55
0.008
F-Value
p-Value
0.062 0.063
0.92 (NS) Postrinsing
Source of variation
df
Between groups A, B, C Within groups Total
2 63 65
Sum of squares 2.56 1.91 4.51
There was no statistically significant difference between the baseline plaque scores as compared to the three mouthwash groups (p=0.87), but there was statistically highly significant difference (p=0.00) observed between the three mouthwash when compared after 1 month. The baseline gingival index scores between the three mouthwashes were statistically nonsignificant (p ¼ 0.92), whereas after 1 month, there was statistically highly significant (p ¼ 0.001) difference (Table 1 and 2). The mean difference between the baseline plaque index and postrinsing plaque index after 1 month was highest in Group A (0.74) and least in Group C (–0.09). A statistically significant difference (p ¼ 0.004) between Group A and Group C and a statistically highly significant difference (p ¼ 0.00) was observed between Group B and Group C but statistically no significant difference between Group A and Group B (p ¼ 0.435) (Table 3).
Mean square
F-Value
p-Value
1.28 0.03 42.78
0.001(HS)
Group A mouthwash showed the highest mean difference of gingival scores between baseline and after 1 month (0.34) while the least was 0.12 observed in saline group. Group A and Group C showed a statistically significant difference (p ¼ 0.003), statistically highly significant difference between Group B and Group C (p ¼ 0.001) but statistically no significant difference between Group A and Group B (p ¼ 0.229) (Table 4).
Mean values of plaque index The mean plaque index scores of the mouthwashes at baseline were 1.5±0.32, 1.22±0.25 and 1.34±0.48 respectively. The highest mean plaque index after 1 month was in Group C (1.46±0.19), the least mean plaque scores after 1 month was 0.68±0.14 in Group B. The range for
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Bhat et al.: Antiplaque effect of herbal and chlorhexidine mouthwash
Table 3 Comparison of the plaque index between mouthwashes by unpaired Student’s t-test. Groups
Mean
Mean
df
t-Value
p-Value
A and B A and C B and C
0.74 0.74 0.56
0.56 −0.09 −0.09
42 43 41
1.43 7.10 7.32
0.435 (NS) 0.004 (S) 0.00 (HS)
Table 4 Comparison of the gingival index between mouthwashes using Student’s t test paired. Groups
Mean
Mean
df
t-Value
p-Value
A and B A and C B and C
0.34 0.34 0.32
0.32 −0.12 −0.12
42 43 41
1.26 7.89 7.92
0.229 (NS) 0.003 (S) 0.001 (HS)
plaque index at baseline was 1.9, 1.8 and 2.1 in Group A, B and C respectively and after 1 month it was 1.23, 1.07 and 3.0 in Group A, B and C respectively (Figure 1).
Mean values of gingival index The mean gingival index score of the mouthwashes at baseline was 0.62 0.52, 0.77 0.43 and 0.91 0.84 respectively. The highest mean gingival index after 1 month was 1.02 0.79 in group C and the least mean gingival index was 0.35 0.46 in group A. The range for prerinsing gingival scores at baseline was 0.94, 0.68 and
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1 respectively, whereas after 1 month the range observed for postrinsing gingival index was 0.68, 0.42 and 2.4 respectively (Figure 2).
The adverse effects related to the mouthwash A majority of the adverse effects resulted in Group B. It was observed that most of the study participants in Group B complained of mild discoloration 18(81.8%), moderate discoloration 2(9.1%) and dry mouth 18(81.8%), whereas taste disturbance was highest in Group C 14(63.6%) as compared to Group B 10(45.4%). The least taste disturbance was seen in Group A 2(9.1%). The burning sensation was highest in Group B 11(50%) as compared to Group A 9(40.9%) and absent in Group C (Figure 3).
Discussion A thorough exploration of the available literature revealed few studies in which different herbal mouthwashes were compared with chlorhexidine mouthwash. The sample size, design, the study period, the indices and the technique used in those studies highly varied from one study to another study. A sincere attempt has been made to compare the available results wherever possible maintaining the validity of the comparisons to the possible extent. The distribution of the study participants according to the age was between 18 and 24 years with the mean age of herbal group, chlorhexidine group and saline
Figure 1 The distribution of the postrinsing plaque index scores of different groups after 1 month.
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Bhat et al.: Antiplaque effect of herbal and chlorhexidine mouthwash
Figure 2 The distribution of the postrinsing gingival index scores after 1 month.
Figure 3 Comparison of the adverse effects of the mouthwashes.
group was 20.2±0.7, 20.95±1.1 and 20.79±1.2 respectively. There was no significant difference (p ¼ 0.356) between the mean age of the three groups. The study shows population selected was homogeneous which was similar to other studies [10, 11]. As compared to the present study, few studies have been done with relatively favourable results as exhibited by herbal mouthrinses. Similar to our study, studies conducted by Parwani et al. [12] and Sikka et al. [13] compared chlorhexidine and herbal mouthwash using Loe and Silness gingival index and Turesky et al. plaque index. Whereas study done by Scherer et al. [14] compared herbal mouthwash and distilled water using Loe and Silness gingival index. Another study conducted by Khalessi et al. [15] compared the oral health efficacy of
Persica mouthwash with that of a placebo using Silness and Loe plaque index. As evident from the result of the present study, there was no significant difference in baseline plaque index (p ¼ 0.87) between the three mouthwashes. In the present study, the herbal mouthwash showed plaque inhibition which lay between the negative and positive control (Table 2). A statistically significant suppression of plaque formation was seen with herbal formulation as compared to placebo solution (p ¼ 0.004) and statistically nonsignificant result with chlorhexidine mouthwash (p ¼ 0.435) showing that chlorhexidine and herbal mouthwash had a comparable effect on plaque formation. The plaque preventing potential of herbal mouthwash, demonstrated in the present investigation, can be attributed to its
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Bhat et al.: Antiplaque effect of herbal and chlorhexidine mouthwash
constituents like S. persica, P. betle, T. bellerica, E. cardamomum and others. S. persica, toothbrush tree, locally called “Miswak” has been proven as an antiplaque agent by numerous studies [12, 16]. Its antiplaque activity might be due to its antimicrobial activity against early and late plaque formers. Sofrata et al. [17] reported antibacterial effect of S. persica against oral pathogens such as Streptococcus mutans, Lactobacillus acidophilus, Actinobacillus actinomycetemcomitans, Porphyromonas gingivalis and Haemophilus influenza. These findings are also supported by the studies of Darout et al. [18] and Almas et al. [19]. However, when antimicrobial effect of S. persica and CHX against S. mutans was compared, chlorhexidine was found to be more potent in reducing the number of S. mutans colonies [20]. Another constituent of the herbal mouthwash, P. betle, has been documented to reduce significantly the cell-surface hydrophobicity of three early plaque settlers such as Streptococcus mitis, Streptococcus sanguis and Actinomyces species [21, 22]. This cell-surface hydrophobicity was well established as a factor involved in the adherence of bacteria to the host tissues [23]. Furthermore, E. cardamomum has been reported to significantly inhibit the growth of oral microflora in in vitro studies [24, 25]. Besides the above-mentioned ingredients, T. bellerica, Mentha Spp. and G. fragrantissima has also proven to possess antimicrobial activity that might contribute to the antiplaque activity exhibited by the herbal mouthwash [26–28]. Our study was consistent with a study done by Rahmani et al. [29] which assessed the effects of S. persica and CHX on plaque formation and noted a comparable plaque inhibition by both the solutions. In our study, there was a statistically highly significant suppression of plaque by chlorhexidine as compared to placebo which was similar to other studies conducted by Gazi et al. [30]. The mean gingival index at baseline was statistically nonsignificant between the three mouthwashes (p ¼ 0.92) which was consistent with other studies [10, 11]. However, the mean gingival index after 1 month was highly significant between chlorhexidine group and saline group (p ¼ 0.001), statistically significant between herbal group and saline group (p ¼ 0.003), whereas the herbal and chlorhexidine group were potentially equivalent in reducing gingivitis (p ¼ 0.229). Our results were similar to the results of other studies conducted by Parwani et al. [12] where herbal and chlorhexidine mouthwashes showed a comparable antigingivitis effect (p ¼ 0.244). Lang LP stated that the substantivity of an antimicrobial agent needs sufficient contact time with a microorganism in order to inhibit or kill it. Chlorhexidine
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with a substantivity of 8–12 h is considered highly effective [28], whereas Hiora herbal mouthwash substantivity is not yet known. On other hand, Jenkin et al. stated that chlorhexidine had immediate bactericidal action on plaque bacteria and plaque fungi and was among the most effective active agents to reduce and inhibit plaque accumulation. It was able to kill both gram-positive and gramnegative microbes. This could be due to the mechanism of action of chlorhexidine on bacteria, which involves the disruption of bacterial cell membrane [31] In the past, many studies suggested that chlorhexidine had the ability to reduce plaque formation and also improved the gingival status. The Hiora mouthwash used in this study is a new commercially available mouthwash with many components having antimicrobial, antifungal, antiseptic properties which have been considered in reducing plaque and gingival scores over a period of time. Khalessi et al. [19] in their study compared the oral health efficacy of persica mouthwash (herbal mouthwash) containing an extract of S. persica with that of a placebo. Plaque accumulation and gingival bleeding were measured before and immediately following the examination period. They concluded that herbal mouthwash resulted in improved gingival health when compared with prerinsing values. Moran et al. [32] conducted a study on comparison of a natural product, triclosan and chlorhexidine mouthwashes in a 4 day plaque regrowth model. They concluded that the natural product was second to chlorhexidine in plaque inhibition. Studies on the plant extract sanguinarine chloride mouthwash and toothpaste have shown that it produces moderate reduction in plaque and gingivitis. Although the plaque regrowth and antigingivitis effect of the chlorhexidine mouthwash was superior to that of herbal mouthwash over placebo, the response of participants to the herbal product, as evaluated by questionnaire, was good. There was mild transient burning sensation with intake of herbal mouthrinse which could be explained due to its concentrated nature. No other side effects had been noticed at the end of the study, which might add to its clinical usage as an adjunct to mechanical oral hygiene measures, whereas chlorhexidine mouthwash showed many adverse effects. A majority of participants in chlorhexidine group (81.8%) complained of mild discoloration, moderate discoloration (9.1%), dry mouth (81.8%), transient taste disturbance (45.4%) and burning sensation (50%). These results were similar to other studies [10, 22]. On the basis of the results obtained, it can be stated that the herbal mouthwash had a promising plaque inhibitory potential. However, studies of longer duration with
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cross-over study design and wash out period would have been more authenticating as it eliminates the bias of viable host. Further studies where safety and microbiological parameters would be evaluated are essential to establish the true effectiveness of the mouthrinse and its position among the other rinses that are used adjunctively to mechanical oral hygiene procedure. Hence, the discovery of bioactive natural products which can reduce the oral diseases may serve as leads in the development of new pharmaceuticals that will be able to address the unmet therapeutic needs in the treatment of various oral diseases at low costs and can be used as alternatives to chemical mouthwashes.
Conclusions The efficacy of herbal mouthwash was equally effective in reducing plaque and gingivitis as compared to chlorhexidine mouthwash. Though chlorhexidine mouthwash considered as a gold standard, it was reported with a number of local side effects including extrinsic tooth and tongue brown staining, taste disturbance, dryness of mouth, burning sensation. These side effects limit its acceptability to users and its long-term use. Whereas Hiora Herbal mouthwash due to its natural ingredients had no reported side effects apart from mild burning sensation. In public health point of view, the herbal mouthwash can serve as a good alternative to patients who wish to avoid alcohol as
in Xerostomics, sugar as in patients suffering from Diabetes and people who wish to avoid any artificial preservatives and artificial colours. Also when socioeconomic factor, side effects of chlorhexidine and liking of the people for natural product need consideration, the herbal mouthwash can serve as a good alternative. However, safety and microbiological parameters need be evaluated that are essential to establish the true effectiveness of this mouthrinse and its position among other rinses that are used adjunctively to mechanical oral hygiene procedures. There is need for hour to investigate other upcoming mouthwashes so as to prove their efficacy as equivalent in reducing the plaque scores and gingival inflammation. Hence from public health point, the findings of the present study suggest that the herbal mouthwash can serve as a better alternative and can be prescribed in clinical practice. Conflict of interest statement Authors’ conflict of interest disclosure: The authors stated that there are no conflicts of interest regarding the publication of this article. Research funding: None declared. Employment or leadership: None declared. Honorarium: None declared. Received January 11, 2014; accepted March 8, 2014; previously published online April 3, 2014
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Bhat et al.: Antiplaque effect of herbal and chlorhexidine mouthwash
12. Parwani SR, Parwani RN, Chitnis PJ, Dadlani HP. Comparative evaluation of antiplaque efficacy of herbal and 0.2% Chlorhexidine gluconate mouthwash in a 4 day plaque regrowth study. J Indian Soc Periodontol 2013;17:72–7. 13. Sikka G, Dodwad V, Chandrashekar KT. Comparative anti-plaque and anti-gingivitis efficacy of two commercially available mouthwashes – 4 weeks clinical study. J Oral Health Community Dent 2011;5:110–12. 14. Scherer W, Gultz J, Lee SS, Kaim J. The ability of an herbal mouthrinse to reduce gingival bleeding. J Clin Dent 1998;9:97–100. 15. Kalessi AM, Pack AR, Thomson WM, Tomkins GR. An in vitro study of the plaque control efficacy of persica, a commercially available herbal mouthwash containing extracts of salvadora persica. Int Dent J 2004;54:279–83. 16. Willershausen B, Kasaj A, Sculean A, Wehrbein H. Influence of a herbal mouthrinse on inflammatory changes of the gingiva in patients with fixed orthodontic appliances. Periodontal Pract 2004;1:255-62. 17. Sofrata AH, Claesson RK, Lingstorm PK, Gustaffson AK. Strong antibacterial effect of Miswak against oral microorganisms associated with periodontitis and caries. J Periodontol 2008;79:1474–9. 18. Darout IA, Christy AA, Skaug N, Egeberg PK. Identification and quantification of some potentially antimicrobial anionic components in Miswak extract. Indian J Pharmacol 2000;32:11–14. 19. Almas K, Zeidi ZA. The immediate antimicrobial effect of a toothbrush and Miswak on cariogenic bacteria: a clinical study. J Contemp Dent Pract 2004;5:105–14. 20. Salehi P, Danaie SM. Comparison of the antibacterial effects of persica mouthwash with chlorhexidine on streptococcus mutans in orthodontic patients. DARU 2006;14:178–82. 21. Razak AF, Othman RY, Rahim ZH. The effect of Piper betle and Psidium guajava extracts on the cell surface hydrophobicity of selected early settlers of dental plaque. J Oral Sci 2006;48:71–5.
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22. Fatilah AR, Rahim ZH. The anti-adherence effect of Piper betle and Pisidium guajava extracts in oral health maintenance. J Oral Sci 2003;45:201–6. 23. Gibbons RJ, Etherden I. Comparative hydrophobicities of oral bacteria and their adherence to salivary pellicles. Infect Immun 1983;41:1190–6. 24. Bissa S, Songara D, Bohra A. Traditions of oral hygiene: chewing of betel (Piper betle L.) leaves. Curr Sci 2007;92:26–8. 25. Bissa S, Songara D, Bohna A. Traditions in oral hygiene: chewing of betel (Piper betle L.) leaves. Curr Sci 2008;92:26–8. 26. Elizabeth KM. Antimicrobial activity of Terminalia bellerica. Indian J Clin Biochem 2005;20:150–3. 27. Sreenivasan P, Jayakumar M, Ignacimuthu S. In vitro antibacterial activity of some plant essential oils. BMC Complement Altern Med 2006;6:39. 28. Carvalho CT, Vignolli VV. Antimicrobial activity of essential oils from plants used in Brazilian popular medicine. In: II WOCMAP congress medicinal and aromatic plants, part 2: pharmacognosy, pharmacology, phytomedicine, toxicology, 2006:65–9. 29. Rahmani ME, Radvar M. The antiplaque effects of Salvadora persica and Padina essential oil in comparison to chlorhexidine in human gingival diseases a randomized placebo controlled clinical trial. Int J Pharmacol 2005;1:311–15. 30. Gazi MI, Lambourne A, Chagla AH. The antiplaque effect of tooth paste containing salvadora persica compared with chlorhexidine gluconate. Clin Prev Dent 2009;9:3–8. 31. Jenkin S, Addy M, Wade W. The mechanism of action of chlorhexidine. A study of plaque growth on enamel inserts in vivo. J Clin Periodontol 1988;15:415–24. 32. Moran J, Addy M, Roberts S. A comparison of natural product, triclosan and chlorhexidine mouthrinses on 4 day plaque regrowth. J Clin Periodontol 2009;19:578–83.
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J Complement Integr Med. 2014; 11(2): 129–137
Nagesh Bhat, Ruchi Mitra*, Swapnil Oza, Vinayak Kumar Mantu, Sharda Bishnoi, Mandeepsinh Gohil and Rupam Gupta
The antiplaque effect of herbal mouthwash in comparison to chlorhexidine in human gingival disease: a randomized placebo controlled clinical trial Abstract Background: The aim of this study was to compare the efficacy, safety, antiplaque and antigingivitis properties of a herbal mouthwash with chlorhexidine mouthwash. Methods: A double-blinded randomized clinical trial was conducted among 72 undergraduate students with age group 18–24 years. They were randomly divided into three mouthwash group with 24 participants in each group. Group A (herbal), Group B (chlorhexidine) and Group C (normal saline).The Turesky et al. 1970 plaque index and Loe and Silness 1963 gingival index was recorded. Student’s t-test and one-way ANOVA were used to test the significance. Results: A statistically highly significant difference was obtained between mouthwash B and C (p ¼ 0.00) and a significant difference between mouthwash A and C (p ¼ 0.004), showing that chlorhexidine was superior to herbal mouthwash and saline. However, there was a nonsignificant difference between mouthwash A and B (p ¼ 0.435) showing that herbal and chlorhexidine mouthwash was equally effective in reducing plaque and gingivitis. Conclusions: The efficacy of herbal mouthwash was equally effective in reducing plaque and gingivitis as compared to chlorhexidine mouthwash and may be considered as a good alternative. The chlorhexidine mouthwash was reported with many side effects which limits its acceptability and long-term use, whereas the presently tested herbal mouthwash had no side effects apart from mild burning sensation. Keywords: chlorhexidine, gingivitis, gingival index, herbal, plaque, plaque index
*Corresponding author: Ruchi Mitra, Department of Public Health Dentistry, Darshan Dental College and Hospital, Loyara, Udaipur 313011, Rajasthan, India, E-mail: [email protected] Nagesh Bhat, Swapnil Oza, Department of Public Health Dentistry, Darshan Dental College and Hospital, Loyara, Udaipur 313011, Rajasthan, India
Vinayak Kumar Mantu, Department of Oral and Maxillofacial Pathology, Darshan Dental College and Hospital, Loyara, Udaipur 313011, Rajasthan, India Sharda Bishnoi, Mandeepsinh Gohil, Rupam Gupta, Department of Public Health Dentistry, Darshan Dental College and Hospital, Loyara, Udaipur 313011, Rajasthan, India
Introduction Dental plaque is a film of microorganisms found on the tooth surface embedded in a matrix of polymers of salivary and bacterial origin. Dental plaque develops naturally on tooth surface and forms part of host defences of the oral cavity by acting as a barrier to colonization by exogenous microorganisms [1]. The gram-positive and gram-negative bacteria that compose oral biofilms produce many metabolites that induce gingivitis [2]. Dental plaque has been proved by extensive research by Harold Loe in 1965 [3] to be paramount factor in initiation and progression of gingival and periodontal diseases. A direct relationship has been demonstrated between plaque levels and the severity of gingivitis. Since plaque is the principal causative factor in gingival and periodontal diseases, the most rational methodology towards the prevention of periodontal diseases would be regular effective removal of plaque by personal oral hygiene [3] Supragingival plaque control is largely the responsibility of the individual, using tooth brushes and interdental cleaning devices. The majority of the population may not perform mechanical plaque removal sufficiently. Thus, antimicrobial mouthrinses that augment daily home care may provide an effective means of removing or controlling bacterial plaque to limit gingivitis and periodontitis [4]. The incorporation of chemical agents with antiplaque or antimicrobial activity into dental products has been proposed as a potential prophylactic method of reducing plaque-mediated conditions. A number of chemical agents
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which have antiseptic or antimicrobial action have been used, with variable success, to inhibit supragingival plaque formation and the development of gingivitis. Several chemical antiplaque agents have been tested but none has shown equal or better results than chlorhexidine without eliciting unfavourable side effects [5, 6]. In order to overcome such side effects, the World Health Organization (WHO) advice researchers to investigate the possible use of natural products such as herb and plant extracts. Plants and naturally derived products from plants have been used to enhance health and have been used for medicinal purposes for thousands of year. Most herbal supplements have been utilized for centuries based on empirical and testimonial support for their efficacy. Development in alternative medicine research has led to many mouthrinses and toothpastes based on plant extracts [4]. A number of clinical studies have shown the effects of using mouth washes extracted from herbs such as Sanguinarina, Myrtus communis, Quercus infectoria, Capparis spinosa and Cinnamon in the prevention of dental plaque accumulation [7, 8]. Recently, a herbal mouthwash has been introduced in clinical practice, which consists of the extracts of Salvadora persica, Terminalia bellerica, Piper betle, essential oils namely Gaultheria fragrantissima, Elettaria cardamomum, flavouring agents Mentha and Trachyspermum ammi. The natural herb S. persica is a medicinal plant whose roots have been used by many people in Africa, South America, Middle East and Asia. The precise method for use of Miswak was recorded by Babylonian 5000 B.C. and the fashion ultimately spread throughout the Greek and Romanian empire. S. persica has anticariogenic and antiplaque effects [9]. P. betle and E. cardamomum have antibiotic action. T. bellerica is an anti-inflammatory and immunity booster. Also, Mentha and T. ammi which are naturally flavouring agents prevent halitosis. The widespread use of mouthwashes as an aid to oral hygiene is a relatively recent phenomenon in the developing countries of the world. Also, the cost-effectiveness of the herbal mouthwash is less as compared to other commercially available chemical-based mouthwashes. Hence, herbal dental products are becoming popular among general public. The in vitro studies conducted on the efficacy of the herbal mouthwash suggest that the herbal mouthwash may be used as compared to chlorhexidine mouthwash. Hence clinical trials are being conducted to see the efficacy of herbal mouthwash in the oral cavity. In this study, an attempt was made to compare the efficacy on plaque, safety
and antigingivitis properties of a herbal mouthwash with chlorhexidine mouthwash among the study participants.
Materials and methods Study population The present study was a double-blinded, parallel designed randomized clinical trial carried out in the Department of Public Health Dentistry, Darshan Dental College and Hospital, Udaipur, Rajasthan, India. It included a total of 72 undergraduate students (37 males and 35 females in the age group of 18–24 years). The ethical clearance was obtained from the Ethical Review Committee of the institution and a written informed consent was obtained from the study participants after explaining in detail about the study.
Inclusion criteria The dental students with age group of 18–24 years, students willing to participate and with dentition of ≥20 teeth and a minimum of 5 teeth per quadrant, no relevant medical history and no periodontal treatment during past 3 months were included.
Exclusion criteria Students with orthodontic appliances or severe misaligned teeth, receiving antibiotic therapy or medication within past 6 months, presence of any systemic illness, subjects availing oral prophylaxis since past 6 months and students unable to comply with study appointment schedule were excluded.
Test solutions Group A (Herbal Mouthwash) Hiora® mouthwash (Himalaya Drug Company, Bangalore, India). Each gram of herbal mouthwash contains extracts of Pilu (S. persica) 5.0 mg, Bibhitaka (T. bellerica) 10.0 mg, Nagavalli (P. betle) 10.0 mg, oils Gandhapura taila (G. fragrantissima) 1.2 mg, Ela (E. cardamomum) 0.2 mg, flavouring agents Peppermint satva (Mentha spp.) 1.6 mg and Yavani satva (Trachyspermum ammi) 0.4 mg.
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Bhat et al.: Antiplaque effect of herbal and chlorhexidine mouthwash
Group B (Chlorhexidine Mouthwash) ClohexPlus® mouthwash (Dr Reddy’s Lab Ltd. Hyderabad, India) containing 0.20% w/v chlorhexidine was used in the present study. Group C (Normal Saline) Nirlife® mouthwash (Inven Pharmaceuticals Pvt. Ltd.; Dhar, Madhya Pradesh, India) containing 0.05% saline was used in the present study. Normal saline was coloured to resemble the mouthwashes.
Study design In order to check the feasibility and validity of the study, a pilot study was carried out. It also meant to assess the acceptability and regularity of using these mouthwashes. From the pilot study, it was found that the overall prevalence of plaque and gingivitis was 80%. Considering for the dropouts logistic and technical problems the sample size was inflated by 20%, hence the sample size was 72 with 24 participants in each group. A self-designed pretested proforma which consisted of three parts: First demographic information like name, age, sex and informed written consent. Second part gingival index and plaque index recorded at baseline and after 1month trial. The third part a questionnaire related to the complaints or discomfort like pain, burning sensation/ itching, dryness of mouth, taste disturbance and discoloration of teeth if any. The assignment of the participants to the groups and the codes to the product was done by a person not involved in the examination. All the subjects were provided with their assigned mouthrinses and were divided into Group A, Group B and Group C randomly using simple lottery method with 24 participants in each group. All the mouthrinses were dispensed in the identical bottles and thereby ensuring a total subject masking. The examiner and the participants were also blinded with regard to the mouthrinse allocated to them thereby ensuring a double-blinded study. Subjects were provided with measuring cups of 10 mL and were instructed to use 10 mL of mouthwash for 1 min carried out twice a day after tooth brushing for a period of 4 weeks (1 month). The gingival index Loe and Silness 1963 and Turesky–Gilmore–Glickman 1970 modification of Quigley–Hein plaque index were used to record the efficacy before rinsing (at baseline) and after 1 month. Prior to the start of the study training and calibration was done in order to check the feasibility and reliability of the study. The Kappa statistical analysis for interexaminer variability for Turesky et al. plaque index and Loe and Silness gingival index was 0.89 and 0.97, whereas the
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intraexaminer was 0.90 and 0.94 respectively showing high degree of conformity in observational judgment. All recordings were made by a single examiner. Plaque was assessed on the labial, buccal and lingual surfaces of all teeth after using disclosing agent (Two-tone dye). The severity of gingivitis was scored by examining the tissues surrounding each tooth that were divided into four gingival scoring units: distal-facial papilla, facial margin, mesial-facial papilla and the entire lingual gingival margin. All the participants were instructed to follow their routine oral hygiene practices along with the assigned regimen and to maintain a reminder sheet on daily product use. Each one of the daily rinses was supervised on each weekday and also supervised by a daily recall message for reminding them to use the assigned mouthwash. The compliance was checked with the help of a reminder sheet by the examiner during surprise recall of the participants. Also, the participants were recalled along with the mouthwash bottles assigned to check for the mouthwash volume used by the participants.
Statistical analysis The obtained data were compiled systematically. Data collected were coded, computerized and analyzed using Statistical package for Social Sciences (SPSS version 17.0). One-way ANOVA and Student’s t-test were used to compare the means of plaque and gingival index values between the three mouthwashes.
Results The study participants were selected according to the inclusion and exclusion criteria. A total of 72 students participated in the study out of which 37 were males and 35 were females with 24 students in each group in the beginning of the study. However, two students did not report after 1 month in spite of several recalls, three students were irregular in using mouthwash found during surprise visit and one of the students became ill and had to quit the study due to antibiotic coverage. Hence, a total of 66 students participated of which 32 were females and 34 were males with 22 students in each group. The mean age for herbal group, chlorhexidine group and saline group was 20.2 0.7, 20.95 .1 and 20.79±1.2 respectively. There was statistically no significant difference (p ¼ 0.356) in the mean age of herbal (Group A), chlorhexidine (Group B) and saline groups (Group C).
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Table 1
Bhat et al.: Antiplaque effect of herbal and chlorhexidine mouthwash
Comparison among the three mouthwashes on plaque index using one-way ANOVA. Prerinsing PI (Baseline)
Source of variation
df
Sum of squares
Mean square
F-Value
Between groups A, B, C Within groups Total
2 63 65
0.068 4.23 4.29
0.032 0.023
0.052
p-Value 0.87 (NSa)
Postrinsing PI Source of variation
df
Between groups A, B, C Within groups Total
2 63 65
Sum of squares 8.51 8.76 17.26
Mean square 4.29 0.14
F-Value
p-Value 0.000 (HSb)
30.62
a
NS, statistically non significant; bHS, statistically highly significant.
Table 2
Comparison among the three mouthwashes on gingival index using one-way ANOVA. Prerinsing (Baseline)
Source of variation
df
Sum of squares
Mean square
Between groups A, B, C Within groups Total
2 63 65
0.006 2.54 2.55
0.008
F-Value
p-Value
0.062 0.063
0.92 (NS) Postrinsing
Source of variation
df
Between groups A, B, C Within groups Total
2 63 65
Sum of squares 2.56 1.91 4.51
There was no statistically significant difference between the baseline plaque scores as compared to the three mouthwash groups (p=0.87), but there was statistically highly significant difference (p=0.00) observed between the three mouthwash when compared after 1 month. The baseline gingival index scores between the three mouthwashes were statistically nonsignificant (p ¼ 0.92), whereas after 1 month, there was statistically highly significant (p ¼ 0.001) difference (Table 1 and 2). The mean difference between the baseline plaque index and postrinsing plaque index after 1 month was highest in Group A (0.74) and least in Group C (–0.09). A statistically significant difference (p ¼ 0.004) between Group A and Group C and a statistically highly significant difference (p ¼ 0.00) was observed between Group B and Group C but statistically no significant difference between Group A and Group B (p ¼ 0.435) (Table 3).
Mean square
F-Value
p-Value
1.28 0.03 42.78
0.001(HS)
Group A mouthwash showed the highest mean difference of gingival scores between baseline and after 1 month (0.34) while the least was 0.12 observed in saline group. Group A and Group C showed a statistically significant difference (p ¼ 0.003), statistically highly significant difference between Group B and Group C (p ¼ 0.001) but statistically no significant difference between Group A and Group B (p ¼ 0.229) (Table 4).
Mean values of plaque index The mean plaque index scores of the mouthwashes at baseline were 1.5±0.32, 1.22±0.25 and 1.34±0.48 respectively. The highest mean plaque index after 1 month was in Group C (1.46±0.19), the least mean plaque scores after 1 month was 0.68±0.14 in Group B. The range for
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Bhat et al.: Antiplaque effect of herbal and chlorhexidine mouthwash
Table 3 Comparison of the plaque index between mouthwashes by unpaired Student’s t-test. Groups
Mean
Mean
df
t-Value
p-Value
A and B A and C B and C
0.74 0.74 0.56
0.56 −0.09 −0.09
42 43 41
1.43 7.10 7.32
0.435 (NS) 0.004 (S) 0.00 (HS)
Table 4 Comparison of the gingival index between mouthwashes using Student’s t test paired. Groups
Mean
Mean
df
t-Value
p-Value
A and B A and C B and C
0.34 0.34 0.32
0.32 −0.12 −0.12
42 43 41
1.26 7.89 7.92
0.229 (NS) 0.003 (S) 0.001 (HS)
plaque index at baseline was 1.9, 1.8 and 2.1 in Group A, B and C respectively and after 1 month it was 1.23, 1.07 and 3.0 in Group A, B and C respectively (Figure 1).
Mean values of gingival index The mean gingival index score of the mouthwashes at baseline was 0.62 0.52, 0.77 0.43 and 0.91 0.84 respectively. The highest mean gingival index after 1 month was 1.02 0.79 in group C and the least mean gingival index was 0.35 0.46 in group A. The range for prerinsing gingival scores at baseline was 0.94, 0.68 and
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1 respectively, whereas after 1 month the range observed for postrinsing gingival index was 0.68, 0.42 and 2.4 respectively (Figure 2).
The adverse effects related to the mouthwash A majority of the adverse effects resulted in Group B. It was observed that most of the study participants in Group B complained of mild discoloration 18(81.8%), moderate discoloration 2(9.1%) and dry mouth 18(81.8%), whereas taste disturbance was highest in Group C 14(63.6%) as compared to Group B 10(45.4%). The least taste disturbance was seen in Group A 2(9.1%). The burning sensation was highest in Group B 11(50%) as compared to Group A 9(40.9%) and absent in Group C (Figure 3).
Discussion A thorough exploration of the available literature revealed few studies in which different herbal mouthwashes were compared with chlorhexidine mouthwash. The sample size, design, the study period, the indices and the technique used in those studies highly varied from one study to another study. A sincere attempt has been made to compare the available results wherever possible maintaining the validity of the comparisons to the possible extent. The distribution of the study participants according to the age was between 18 and 24 years with the mean age of herbal group, chlorhexidine group and saline
Figure 1 The distribution of the postrinsing plaque index scores of different groups after 1 month.
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Bhat et al.: Antiplaque effect of herbal and chlorhexidine mouthwash
Figure 2 The distribution of the postrinsing gingival index scores after 1 month.
Figure 3 Comparison of the adverse effects of the mouthwashes.
group was 20.2±0.7, 20.95±1.1 and 20.79±1.2 respectively. There was no significant difference (p ¼ 0.356) between the mean age of the three groups. The study shows population selected was homogeneous which was similar to other studies [10, 11]. As compared to the present study, few studies have been done with relatively favourable results as exhibited by herbal mouthrinses. Similar to our study, studies conducted by Parwani et al. [12] and Sikka et al. [13] compared chlorhexidine and herbal mouthwash using Loe and Silness gingival index and Turesky et al. plaque index. Whereas study done by Scherer et al. [14] compared herbal mouthwash and distilled water using Loe and Silness gingival index. Another study conducted by Khalessi et al. [15] compared the oral health efficacy of
Persica mouthwash with that of a placebo using Silness and Loe plaque index. As evident from the result of the present study, there was no significant difference in baseline plaque index (p ¼ 0.87) between the three mouthwashes. In the present study, the herbal mouthwash showed plaque inhibition which lay between the negative and positive control (Table 2). A statistically significant suppression of plaque formation was seen with herbal formulation as compared to placebo solution (p ¼ 0.004) and statistically nonsignificant result with chlorhexidine mouthwash (p ¼ 0.435) showing that chlorhexidine and herbal mouthwash had a comparable effect on plaque formation. The plaque preventing potential of herbal mouthwash, demonstrated in the present investigation, can be attributed to its
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Bhat et al.: Antiplaque effect of herbal and chlorhexidine mouthwash
constituents like S. persica, P. betle, T. bellerica, E. cardamomum and others. S. persica, toothbrush tree, locally called “Miswak” has been proven as an antiplaque agent by numerous studies [12, 16]. Its antiplaque activity might be due to its antimicrobial activity against early and late plaque formers. Sofrata et al. [17] reported antibacterial effect of S. persica against oral pathogens such as Streptococcus mutans, Lactobacillus acidophilus, Actinobacillus actinomycetemcomitans, Porphyromonas gingivalis and Haemophilus influenza. These findings are also supported by the studies of Darout et al. [18] and Almas et al. [19]. However, when antimicrobial effect of S. persica and CHX against S. mutans was compared, chlorhexidine was found to be more potent in reducing the number of S. mutans colonies [20]. Another constituent of the herbal mouthwash, P. betle, has been documented to reduce significantly the cell-surface hydrophobicity of three early plaque settlers such as Streptococcus mitis, Streptococcus sanguis and Actinomyces species [21, 22]. This cell-surface hydrophobicity was well established as a factor involved in the adherence of bacteria to the host tissues [23]. Furthermore, E. cardamomum has been reported to significantly inhibit the growth of oral microflora in in vitro studies [24, 25]. Besides the above-mentioned ingredients, T. bellerica, Mentha Spp. and G. fragrantissima has also proven to possess antimicrobial activity that might contribute to the antiplaque activity exhibited by the herbal mouthwash [26–28]. Our study was consistent with a study done by Rahmani et al. [29] which assessed the effects of S. persica and CHX on plaque formation and noted a comparable plaque inhibition by both the solutions. In our study, there was a statistically highly significant suppression of plaque by chlorhexidine as compared to placebo which was similar to other studies conducted by Gazi et al. [30]. The mean gingival index at baseline was statistically nonsignificant between the three mouthwashes (p ¼ 0.92) which was consistent with other studies [10, 11]. However, the mean gingival index after 1 month was highly significant between chlorhexidine group and saline group (p ¼ 0.001), statistically significant between herbal group and saline group (p ¼ 0.003), whereas the herbal and chlorhexidine group were potentially equivalent in reducing gingivitis (p ¼ 0.229). Our results were similar to the results of other studies conducted by Parwani et al. [12] where herbal and chlorhexidine mouthwashes showed a comparable antigingivitis effect (p ¼ 0.244). Lang LP stated that the substantivity of an antimicrobial agent needs sufficient contact time with a microorganism in order to inhibit or kill it. Chlorhexidine
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with a substantivity of 8–12 h is considered highly effective [28], whereas Hiora herbal mouthwash substantivity is not yet known. On other hand, Jenkin et al. stated that chlorhexidine had immediate bactericidal action on plaque bacteria and plaque fungi and was among the most effective active agents to reduce and inhibit plaque accumulation. It was able to kill both gram-positive and gramnegative microbes. This could be due to the mechanism of action of chlorhexidine on bacteria, which involves the disruption of bacterial cell membrane [31] In the past, many studies suggested that chlorhexidine had the ability to reduce plaque formation and also improved the gingival status. The Hiora mouthwash used in this study is a new commercially available mouthwash with many components having antimicrobial, antifungal, antiseptic properties which have been considered in reducing plaque and gingival scores over a period of time. Khalessi et al. [19] in their study compared the oral health efficacy of persica mouthwash (herbal mouthwash) containing an extract of S. persica with that of a placebo. Plaque accumulation and gingival bleeding were measured before and immediately following the examination period. They concluded that herbal mouthwash resulted in improved gingival health when compared with prerinsing values. Moran et al. [32] conducted a study on comparison of a natural product, triclosan and chlorhexidine mouthwashes in a 4 day plaque regrowth model. They concluded that the natural product was second to chlorhexidine in plaque inhibition. Studies on the plant extract sanguinarine chloride mouthwash and toothpaste have shown that it produces moderate reduction in plaque and gingivitis. Although the plaque regrowth and antigingivitis effect of the chlorhexidine mouthwash was superior to that of herbal mouthwash over placebo, the response of participants to the herbal product, as evaluated by questionnaire, was good. There was mild transient burning sensation with intake of herbal mouthrinse which could be explained due to its concentrated nature. No other side effects had been noticed at the end of the study, which might add to its clinical usage as an adjunct to mechanical oral hygiene measures, whereas chlorhexidine mouthwash showed many adverse effects. A majority of participants in chlorhexidine group (81.8%) complained of mild discoloration, moderate discoloration (9.1%), dry mouth (81.8%), transient taste disturbance (45.4%) and burning sensation (50%). These results were similar to other studies [10, 22]. On the basis of the results obtained, it can be stated that the herbal mouthwash had a promising plaque inhibitory potential. However, studies of longer duration with
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cross-over study design and wash out period would have been more authenticating as it eliminates the bias of viable host. Further studies where safety and microbiological parameters would be evaluated are essential to establish the true effectiveness of the mouthrinse and its position among the other rinses that are used adjunctively to mechanical oral hygiene procedure. Hence, the discovery of bioactive natural products which can reduce the oral diseases may serve as leads in the development of new pharmaceuticals that will be able to address the unmet therapeutic needs in the treatment of various oral diseases at low costs and can be used as alternatives to chemical mouthwashes.
Conclusions The efficacy of herbal mouthwash was equally effective in reducing plaque and gingivitis as compared to chlorhexidine mouthwash. Though chlorhexidine mouthwash considered as a gold standard, it was reported with a number of local side effects including extrinsic tooth and tongue brown staining, taste disturbance, dryness of mouth, burning sensation. These side effects limit its acceptability to users and its long-term use. Whereas Hiora Herbal mouthwash due to its natural ingredients had no reported side effects apart from mild burning sensation. In public health point of view, the herbal mouthwash can serve as a good alternative to patients who wish to avoid alcohol as
in Xerostomics, sugar as in patients suffering from Diabetes and people who wish to avoid any artificial preservatives and artificial colours. Also when socioeconomic factor, side effects of chlorhexidine and liking of the people for natural product need consideration, the herbal mouthwash can serve as a good alternative. However, safety and microbiological parameters need be evaluated that are essential to establish the true effectiveness of this mouthrinse and its position among other rinses that are used adjunctively to mechanical oral hygiene procedures. There is need for hour to investigate other upcoming mouthwashes so as to prove their efficacy as equivalent in reducing the plaque scores and gingival inflammation. Hence from public health point, the findings of the present study suggest that the herbal mouthwash can serve as a better alternative and can be prescribed in clinical practice. Conflict of interest statement Authors’ conflict of interest disclosure: The authors stated that there are no conflicts of interest regarding the publication of this article. Research funding: None declared. Employment or leadership: None declared. Honorarium: None declared. Received January 11, 2014; accepted March 8, 2014; previously published online April 3, 2014
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Bhat et al.: Antiplaque effect of herbal and chlorhexidine mouthwash
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