DOI: 10.1111/ipd.12134 SHORT COMMUNICATION
Children’s discomfort may vary among different treatments for initial approximal caries lesions: preliminary findings of a randomized controlled clinical trial JULIANA MATTOS-SILVEIRA, ISABELA FLORIANO, FERNANDA R. FERREIRA, MARIA FAUSTO M. MENDES & MARIANA M. BRAGA EDUARDA F. VIGANO, Department of Pediatric Dentistry, School of Dentistry, University of S~ ao Paulo, S~ ao Paulo, Brazil
International Journal of Paediatric Dentistry 2015; 25: 300–304 Background. Longer and more complex dental
procedures could negatively affect patient’s acceptability of minimal invasive techniques. Aims and Methods. Therefore, this short communication aims to show the preliminary findings regarding children’s discomfort reported after some minimal invasive treatments in treating ini-
Introduction
Minimizing patient’s discomfort is one of the proposals of minimal invasive treatments1, which is important especially in dealing with paediatric patients’ dental anxiety and fear2. Few studies have assessed discomfort reported by children after minimal interventions for treating initial caries lesions, and they are majorly focused on most complex treatments and have not been concerned with comparing different options of treatments3,4. However, simplest restorative techniques may help to decrease children’s discomfort5, as they require less time for application or fewer number of clinical steps and demand painless procedures, avoiding fear/anxiety and need for local anaesthesia. Even among minimal invasive treatments for initial caries lesions, there are operational differences that could interfere on children’s discomfort. Thus, longer and more complex procedures could negatively affect patient’s acceptability of such techniques. Correspondence to: M.M. Braga, Departamento de Odontopediatria, Faculdade de Odontologia, Universidade de S~ ao Paulo, Av. Lineu Prestes, 2227, S~ao Paulo, SP 05508-000, Brasil. E-mail: [email protected]
300
tial caries lesions on approximal surfaces: flossing instruction, silver diamine fluoride (SDF) application and caries resin infiltration. Results. Children allocated in the infiltration group showed higher levels of discomfort than those in the SDF and control groups. Conclusions. These findings suggest that the simplest interventions for approximal initial caries lesions cause less discomfort for children and should be applied where possible.
Instruction for controlling biofilm by flossing, silver diamine fluoride (SDF) application and caries resin infiltration are minimally invasive interventions that are being tested in an ongoing randomized, double-blind, placebo-controlled clinical trial with parallel groups for assessing cost-efficacy in controlling initial approximal caries lesions [Ethical Research Committee (protocol 140/11)/ClinicalTrials.gov (NCT01477385)]. These treatments require operational techniques with different levels of complexity. Hence, this short communication aims to show preliminary findings regarding children’s discomfort reported after these treatments, which was a patient-centred outcome investigated. Methods
Sample size was calculated considering the primary endpoint (caries progression), a = 5%, 1–b = 80% and previously published results regarding caries progression rates6. One hundred and forty-one children aged between 3 and 10 years who sought for dental treatment in local dental school were included, resulting to a sample power of 99.9% for the outcome discussed in this study. Children who had at least one active initial caries lesion on
© 2014 BSPD, IAPD and John Wiley & Sons A/S. Published by John Wiley & Sons Ltd
Treatment of initial approximal caries
approximal surface of the primary molars were included. Lesions were detected directly by visuo-tactile examinations after temporary separation with orthodontic rubbers. Bitewing radiographic examinations were used to not to include any possible advanced dentine caries lesions6. Children with negative behaviours were eligible subjects, but they were excluded from the initial sample. Children’s assents and guardians’ informed consents were obtained previous to child’s enrolment7. Three parallel groups were defined according to active treatment received: resin infiltrant (Iconâ, Dental Milestones Guaranteed-DMG, Hamburg, Germany), SDF (Cariestopâ 30%, Biodin^ amica Quımica e Farmac^ eutica LTDA, Ibipor~ a, Paran a, Brazil) and control group (flossing instructions). The allocation was randomly determined using statistical software (Medcalc software version 12.4.0.0, Ostend, Belgium) and was distributed in opaque and sealed envelopes, which were opened by the operator (JMS) after the enrolment and allocation process. All children enrolled in the study received in each included surface: the active intervention according to manufacturer’s recommendations, the placebo therapy and instruction for daily flossing of this specific surface. When the active treatment was exclusively flossing, two placebo therapies were used. All procedures were performed sequentially by trained paediatric dentist (JMS) in the same appointment. Placebo therapy simulated the treatment to which children have not been allocated. Water was used instead of the real product and was applied using similar appliances for real treatments. For ethical issues, the placebo corresponding to resin infiltrant was simulated with rubber dam, without local infiltration anaesthesia and clamp. Children reported their discomfort after treatment interventions by expressing, to an external examiner (FRF/MEFV), their feelings on the Wong-Baker faces scale8. Reported discomfort was set as the primary outcome for this communication9,10 and was assessed immediately after the sequence of treatments had been performed. Child’s baseline reported discomfort was also collected after clinical examination in a previous appointment. The time spent on interventions was measured by
301
an external examiner and was considered as the secondary outcome. For this outcome, only the duration of the active treatment was considered. Poisson regression analyses were performed to verify association among discomfort reported by children after interventions (ordinal variable) and independent variables: treatment (group), sex, age, time spent in the intervention and child’s baseline discomfort (those reported after a clinical examination appointment). A level of significance of 0.20 in the unadjusted analyses was regarded for variables entry into the model, and a level of 0.05 was considered to be retained in the final models. Rate ratios (RR) were calculated with 95% of confidence interval (CI). Analysis of variance was performed to compare time spent in different treatments; hence, the level of significance adopted was 5%. Results and Discussion
Flow diagram shows the enrolment, allocation and analysis regarding this study (Fig. 1). Positive response rate was 88%. Children were mostly girls (52.48%), and their mean age standard deviation (SD) was 6.56 1.69. Table 1 shows the distribution of sample per group. After sequential interventions, 22% of children reported some level of discomfort. Notwithstanding, children in SDF and control group reported less discomfort than those in infiltrant group (P < 0.05) (Table 2). Most of the children who reported discomfort referred to the score 1 (hurts little bit) in the WongBaker scale, but some children cried and reported the score 5 (hurts worst) only in the infiltrant group. Time spent in resin infiltration (mean 38.21 min SD: 8.71) was greater than that in SDF application (mean 22.61 min SD: 4.79) and flossing instruction (mean 18.82 min SD: 5.48) groups. In addition, the child’s reported discomfort was higher in the resin infiltrant group (median = 0; 95% CI: 0 to 1, maximum value: 5) than in others (SDF: median = 0; 95%CI: 0–0, maximum value: 2; control: median = 0; 95%CI: 0–0, maximum value: 1) (Table 2).
© 2014 BSPD, IAPD and John Wiley & Sons A/S. Published by John Wiley & Sons Ltd
302
J. Mattos-Silveira et al.
Figure 1. Flow diagram of enrolment, allocation and analysis of participants in this study (CONSORT, 2010).
Table 1. Distribution of sample regarding each treatment group. Variables Gender
Age Baseline discomfort
n (%) Girls Boys Mean (SD) Median (95% CI) Maximum value
Resin infiltrant
SDF
22 25 6.74 0 2
21 26 6.46 0 1
(15.60) (17.73) (1.60) (0–0)
Control
(14.89) (18.43) (1.85) (0–0)
31 16 6.48 0 2
(21.98) (11.34) (1.64) (0–0)
SD, standard deviation; CI, confidence interval.
Child’s age was not associated with the reported discomfort, but children that reported higher discomfort in the clinical examination reported higher level of discomfort after treatment appointment (Table 2). Besides, when the group was considered, boys presented higher level of discomfort than girls (Table 2). Findings of this study showed that, among minimally invasive options for treating initial approximal caries, the simplest intervention, such as flossing instructions and SDF application, caused less children’s discomfort than
complex techniques, such as resin infiltration, that requires more number of clinical steps as well as the use of rubber dam and clamps in conjunction with local anaesthesia. Resin infiltration generally has been well accepted by patients, mainly young adults, but it has not ever been compared with other techniques3. Although the previous study has not performed local anaesthesia previous to isolation, this approach was used in this study, as children could probably present more discomfort with this kind of procedure, and especially when treating children, the
© 2014 BSPD, IAPD and John Wiley & Sons A/S. Published by John Wiley & Sons Ltd
Treatment of initial approximal caries
303
Table 2. Poisson regression analysis between children’s reported discomfort after treatment session and independent variables.
Variables Baseline discomfort* Groups
Age Sex
Time of active intervention
Median (95% CI) Max n (%) Infiltrant SDF Control Mean (SD) n (%) Girls Boys Mean (SD)
0 (0 to 0) 2
Unadjusted RR (95% CI)
P
Adjusted RR (95% CI)
P
2.42 (1.66–3.52)
Children’s discomfort may vary among different treatments for initial approximal caries lesions: preliminary findings of a randomized controlled clinical trial JULIANA MATTOS-SILVEIRA, ISABELA FLORIANO, FERNANDA R. FERREIRA, MARIA FAUSTO M. MENDES & MARIANA M. BRAGA EDUARDA F. VIGANO, Department of Pediatric Dentistry, School of Dentistry, University of S~ ao Paulo, S~ ao Paulo, Brazil
International Journal of Paediatric Dentistry 2015; 25: 300–304 Background. Longer and more complex dental
procedures could negatively affect patient’s acceptability of minimal invasive techniques. Aims and Methods. Therefore, this short communication aims to show the preliminary findings regarding children’s discomfort reported after some minimal invasive treatments in treating ini-
Introduction
Minimizing patient’s discomfort is one of the proposals of minimal invasive treatments1, which is important especially in dealing with paediatric patients’ dental anxiety and fear2. Few studies have assessed discomfort reported by children after minimal interventions for treating initial caries lesions, and they are majorly focused on most complex treatments and have not been concerned with comparing different options of treatments3,4. However, simplest restorative techniques may help to decrease children’s discomfort5, as they require less time for application or fewer number of clinical steps and demand painless procedures, avoiding fear/anxiety and need for local anaesthesia. Even among minimal invasive treatments for initial caries lesions, there are operational differences that could interfere on children’s discomfort. Thus, longer and more complex procedures could negatively affect patient’s acceptability of such techniques. Correspondence to: M.M. Braga, Departamento de Odontopediatria, Faculdade de Odontologia, Universidade de S~ ao Paulo, Av. Lineu Prestes, 2227, S~ao Paulo, SP 05508-000, Brasil. E-mail: [email protected]
300
tial caries lesions on approximal surfaces: flossing instruction, silver diamine fluoride (SDF) application and caries resin infiltration. Results. Children allocated in the infiltration group showed higher levels of discomfort than those in the SDF and control groups. Conclusions. These findings suggest that the simplest interventions for approximal initial caries lesions cause less discomfort for children and should be applied where possible.
Instruction for controlling biofilm by flossing, silver diamine fluoride (SDF) application and caries resin infiltration are minimally invasive interventions that are being tested in an ongoing randomized, double-blind, placebo-controlled clinical trial with parallel groups for assessing cost-efficacy in controlling initial approximal caries lesions [Ethical Research Committee (protocol 140/11)/ClinicalTrials.gov (NCT01477385)]. These treatments require operational techniques with different levels of complexity. Hence, this short communication aims to show preliminary findings regarding children’s discomfort reported after these treatments, which was a patient-centred outcome investigated. Methods
Sample size was calculated considering the primary endpoint (caries progression), a = 5%, 1–b = 80% and previously published results regarding caries progression rates6. One hundred and forty-one children aged between 3 and 10 years who sought for dental treatment in local dental school were included, resulting to a sample power of 99.9% for the outcome discussed in this study. Children who had at least one active initial caries lesion on
© 2014 BSPD, IAPD and John Wiley & Sons A/S. Published by John Wiley & Sons Ltd
Treatment of initial approximal caries
approximal surface of the primary molars were included. Lesions were detected directly by visuo-tactile examinations after temporary separation with orthodontic rubbers. Bitewing radiographic examinations were used to not to include any possible advanced dentine caries lesions6. Children with negative behaviours were eligible subjects, but they were excluded from the initial sample. Children’s assents and guardians’ informed consents were obtained previous to child’s enrolment7. Three parallel groups were defined according to active treatment received: resin infiltrant (Iconâ, Dental Milestones Guaranteed-DMG, Hamburg, Germany), SDF (Cariestopâ 30%, Biodin^ amica Quımica e Farmac^ eutica LTDA, Ibipor~ a, Paran a, Brazil) and control group (flossing instructions). The allocation was randomly determined using statistical software (Medcalc software version 12.4.0.0, Ostend, Belgium) and was distributed in opaque and sealed envelopes, which were opened by the operator (JMS) after the enrolment and allocation process. All children enrolled in the study received in each included surface: the active intervention according to manufacturer’s recommendations, the placebo therapy and instruction for daily flossing of this specific surface. When the active treatment was exclusively flossing, two placebo therapies were used. All procedures were performed sequentially by trained paediatric dentist (JMS) in the same appointment. Placebo therapy simulated the treatment to which children have not been allocated. Water was used instead of the real product and was applied using similar appliances for real treatments. For ethical issues, the placebo corresponding to resin infiltrant was simulated with rubber dam, without local infiltration anaesthesia and clamp. Children reported their discomfort after treatment interventions by expressing, to an external examiner (FRF/MEFV), their feelings on the Wong-Baker faces scale8. Reported discomfort was set as the primary outcome for this communication9,10 and was assessed immediately after the sequence of treatments had been performed. Child’s baseline reported discomfort was also collected after clinical examination in a previous appointment. The time spent on interventions was measured by
301
an external examiner and was considered as the secondary outcome. For this outcome, only the duration of the active treatment was considered. Poisson regression analyses were performed to verify association among discomfort reported by children after interventions (ordinal variable) and independent variables: treatment (group), sex, age, time spent in the intervention and child’s baseline discomfort (those reported after a clinical examination appointment). A level of significance of 0.20 in the unadjusted analyses was regarded for variables entry into the model, and a level of 0.05 was considered to be retained in the final models. Rate ratios (RR) were calculated with 95% of confidence interval (CI). Analysis of variance was performed to compare time spent in different treatments; hence, the level of significance adopted was 5%. Results and Discussion
Flow diagram shows the enrolment, allocation and analysis regarding this study (Fig. 1). Positive response rate was 88%. Children were mostly girls (52.48%), and their mean age standard deviation (SD) was 6.56 1.69. Table 1 shows the distribution of sample per group. After sequential interventions, 22% of children reported some level of discomfort. Notwithstanding, children in SDF and control group reported less discomfort than those in infiltrant group (P < 0.05) (Table 2). Most of the children who reported discomfort referred to the score 1 (hurts little bit) in the WongBaker scale, but some children cried and reported the score 5 (hurts worst) only in the infiltrant group. Time spent in resin infiltration (mean 38.21 min SD: 8.71) was greater than that in SDF application (mean 22.61 min SD: 4.79) and flossing instruction (mean 18.82 min SD: 5.48) groups. In addition, the child’s reported discomfort was higher in the resin infiltrant group (median = 0; 95% CI: 0 to 1, maximum value: 5) than in others (SDF: median = 0; 95%CI: 0–0, maximum value: 2; control: median = 0; 95%CI: 0–0, maximum value: 1) (Table 2).
© 2014 BSPD, IAPD and John Wiley & Sons A/S. Published by John Wiley & Sons Ltd
302
J. Mattos-Silveira et al.
Figure 1. Flow diagram of enrolment, allocation and analysis of participants in this study (CONSORT, 2010).
Table 1. Distribution of sample regarding each treatment group. Variables Gender
Age Baseline discomfort
n (%) Girls Boys Mean (SD) Median (95% CI) Maximum value
Resin infiltrant
SDF
22 25 6.74 0 2
21 26 6.46 0 1
(15.60) (17.73) (1.60) (0–0)
Control
(14.89) (18.43) (1.85) (0–0)
31 16 6.48 0 2
(21.98) (11.34) (1.64) (0–0)
SD, standard deviation; CI, confidence interval.
Child’s age was not associated with the reported discomfort, but children that reported higher discomfort in the clinical examination reported higher level of discomfort after treatment appointment (Table 2). Besides, when the group was considered, boys presented higher level of discomfort than girls (Table 2). Findings of this study showed that, among minimally invasive options for treating initial approximal caries, the simplest intervention, such as flossing instructions and SDF application, caused less children’s discomfort than
complex techniques, such as resin infiltration, that requires more number of clinical steps as well as the use of rubber dam and clamps in conjunction with local anaesthesia. Resin infiltration generally has been well accepted by patients, mainly young adults, but it has not ever been compared with other techniques3. Although the previous study has not performed local anaesthesia previous to isolation, this approach was used in this study, as children could probably present more discomfort with this kind of procedure, and especially when treating children, the
© 2014 BSPD, IAPD and John Wiley & Sons A/S. Published by John Wiley & Sons Ltd
Treatment of initial approximal caries
303
Table 2. Poisson regression analysis between children’s reported discomfort after treatment session and independent variables.
Variables Baseline discomfort* Groups
Age Sex
Time of active intervention
Median (95% CI) Max n (%) Infiltrant SDF Control Mean (SD) n (%) Girls Boys Mean (SD)
0 (0 to 0) 2
Unadjusted RR (95% CI)
P
Adjusted RR (95% CI)
P
2.42 (1.66–3.52)
