DOI: 10.1111/ipd.12097

Acceptability of different caries management methods for primary molars in a RCT RUTH M. SANTAMARIA1, NICOLA P.T. INNES2, VITA MACHIULSKIENE3, DAFYDD J.P. EVANS2, MOHAMMAD ALKILZY1 & CHRISTIAN H. SPLIETH1 1

Department of Preventive and Pediatric Dentistry, Ernst-Moritz-Arndt University of Greifswald, Greifswald, Germany, Unit of Dental and Oral Health, School of Dentistry, University of Dundee, Dundee, UK, and 3Clinic of Dental and Oral Pathology, Faculty of Odontology, Lithuanian University of Health Sciences, Kaunas, Lithuania

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International Journal of Paediatric Dentistry 2015; 25: 9–17 Background. More conservative techniques for

managing dental caries including ‘partial’ and ‘no caries removal’ have been increasingly of interest. Aim. To compare children’s behaviour and pain perception, also technique acceptability (parents and dentists), when approximal dentinal lesions (ICDAS 3–5) in primary molars (3–8-year-olds) were managed with three treatment strategies; conventional restorations (CR), hall technique (HT), and non-restorative caries treatment (NRCT). Design. Secondary care-based, three-arm parallelgroup, randomised controlled trial, with 169 participants treated by 12 dentists. Outcome measures: child’s pain perception (Visual Analogue Scale of Faces); behaviour (Frankl scale);

Introduction

In paediatric dentistry, the common challenge for clinicians and parents is to allow children to experience dental treatment in an atmosphere created to empower the child and maximise their ability to cooperate with, and accept treatment. Although the behaviour of dentists and dental staff plays an important role in behaviour management of paediatric patients, there is evidence that different types of treatment might influence children’s behaviour and perceptions of dental treatment1–4. For carious primary teeth, the ideal ‘childfriendly’ therapy would be to manage the caries lesion without causing the child any stress, preserving pulp vitality, and guaranteeCorrespondence to: Ruth M. Santamaria, Department of Preventive and Pediatric Dentistry, Ernst-Moritz-Arndt University of Greifswald, Rotgerberstr. 8, 17487 Greifswald, Germany. E-mail: [email protected]

and parents’ and dentists’ treatment opinions (5-point Likert scales). Results. Children showed more negative behaviour in the CR group (37%) compared to NRCT (21%) and HT (13%) (P = 0.047, CI = 0.41 to 0.52). Pain intensity was rated ‘very low’ or ‘low’ in 88% NRCT, 81% HT, and 72% CR (P = 0.11, CI = 0.10 to 0.12). NRCT and HT were ‘very easy’ or ‘easy’ to perform for >77% of dentists, compared to 50% in CR group (P < 0.000). There were no statistically significant differences in parents’ rating of their child’s level of comfort (P = 0.46, CI = 0.45 to 0.48). Conclusions. Dentists reported more negative behaviour in CR group. For all techniques, children’s pain perception and dentist/parent acceptability were similar.

ing that the treated tooth remains symptomless until it sheds naturally. Over the last decade, there has been a move away from the conventional restorative (CR) approach to more conservative techniques, which embrace changing the carious lesion environment to no longer favour cariogenic biofilm development5. Specific to primary teeth, two of these treatment approaches, which are becoming increasingly widely used, are the hall technique (HT)6, involving no caries removal and sealing, and non-restorative caries treatment (NRCT)7. Although there is growing interest in NRCT, there is limited investigative work to support its use8–10. Nevertheless, current guidelines in the UK11 and USA12 still recommend complete caries removal and placement of a restoration for carious primary teeth. The need for outcomes to ‘portray the perspectives of patients…’ and therefore consider their perceptions of treatment has been discussed in the literature13. Caries management and restorative-related studies in chil-

© 2014 BSPD, IAPD and John Wiley & Sons A/S. Published by John Wiley & Sons Ltd

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dren tend to report their results as technique/ material efficacy and/or longevity of the restoration. Behaviour of, and discomfort experienced by, children during dental treatments is rarely considered as treatment outcomes and reported on. This study aims to compare children’s behaviour and pain perception when approximal dentinal caries lesions in primary molars (in children aged 3–8 years old) were managed with three treatment strategies; conventional restorations (CR), the hall technique (HT), and non-restorative caries treatment (NRCT). The acceptability of the techniques to parents and dentists was also investigated. This report is part of a long-term clinical trial, which aims to determine the clinical efficacy of three caries treatment approaches CR, HT, and NRCT in primary teeth. Results related to the clinical outcomes and potential failures will be examined after 1 year and 2 years follow-up. Materials and methods

Study design and ethical approval This is a secondary care-based three-arm, parallel-group, patient-randomised controlled trial (RCT) conducted in the Paediatric Dentistry Department of Greifswald University, Germany. Ethical approval was obtained from the Research Ethics Committee of the University of Greifswald, under the protocol number BB 39/11 (Registration number NCT01797458). The study was conducted in accordance with the principles for medical research involving human subjects described by the Helsinki Declaration.

col was explained to, and discussed with, the dentists. Training consisted of instruction in carrying out the interventions in each arm with video and ‘hands on’ training for areas that each individual felt less confident in, especially the hall technique and NRCT, and calibration on outcome measurements. Participant screening and eligibility assessment A single researcher (RS) screened for possible study participants. Children aged 3–8 years old, and their parents, were invited to participate in the study if they met the following inclusion criteria: 1) at least one primary molar tooth with caries into dentine involving two dental surfaces (diagnosed according to ICDAS, codes 3–5); 2) willing to be examined. Exclusion criteria were as follows: 1) clinical or radiographic signs or symptoms of pulpal or periradicular pathology (including pain); 2) patients with a systemic disease requiring special considerations during their dental treatment; and 3) parents/children who declined to participate in the study. Only one tooth per child was included in the study. Where more than one tooth per child was eligible for inclusion, the next tooth on the prescribed treatment plan, at the time of screening by one of the researchers (RS), was chosen for the study. Parents of participants had the study discussed with them and gave written consent for their children to participate. Details of patient recruitment and follow-up are presented in the Consort diagram (Fig. 1)14.

Treating dentists To increase generalisability, treatments were carried out by 12 different dentists (seven paediatric specialists and five post-graduate paediatric students, all of whom treat 10–20 patients per week, with an average age of three to 6 years old). The majority of the dentists (75%) were 26–45 years old (mean = 35.1; SD = 10.3), with 58% female and 42% male. Before recruiting any patients, the study proto-

Treatment appointment Following consent, participants were sequentially randomised, using a computer-generated random number list with allocation concealment, to one of three arms. Parents were always present when treatment was performed. 1) Conventional restoration (CR): Local anaesthesia was used where needed, according to child’s requirement and

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Caries treatment methods for children: Acceptability

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Fig. 1. Study CONSORT diagram14.

operator preference. A high-speed handpiece was used to gain access to the lesion; peripheral caries was removed with a slow handpiece and an excavator to cleave away the carious dentine from the pulpal wall. A matrix band was then used (T-Bands, Pulpdent, Watertown, MA, USA; or porta-matrix Tofflemire Retainer with Tofflemire Bands, Henry Schein Inc., Melville, NY, USA) and a wedge (Interdental Wedges, Kerr, Biogglo, Switzerland), applied to tightly hold the band against the tooth. All the cavities were restored with Compomer (Dyract, Dentsply, Konstanz, Germany). 2) Hall technique (HT): following the HT manual (http://dentistry.dundee.ac.uk/ cariology), to place the crown, no caries removal or tooth preparation were carried out and no local anaesthesia was placed. Hall crowns were cemented with glass ionomer luting cement (GC Fuji TRIAGE, GC corporation, Tokyo, Japan).

3) Non-restorative caries treatment (NRCT): approximal carious lesions were opened using a high-speed bur to remove the undermined and overhanging enamel and make the cavity accessible for plaque removal, without the use of local anaesthesia. After removal of any residual plaque with a rotary bristle brush, fluoride varnish (Duraphat, GABA, Lörrach, Germany) was applied to the cavity. Tooth-brushing instructions were given to the parents/children, both in general for the whole mouth and site-specific for the treated tooth. Outcome measures Immediately following treatment, the childrens’, parents’, and dentists’ perceptions and opinions of the treatment at that particular appointment were assessed: 1) Behaviour: Child’s behaviour during the operative session was assessed by the dentists using the Frankl Behavior Rating

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Scale15. This four-point scale ranges from definitely negative behaviour, when the child refuses the treatment, cry, etc., to definitely positive behaviour, when the child is completely cooperative. 2) Pain: The VASOF16 was used to measure pain experience. The five-point scale includes five faces of children representing from very light to very intense pain. Children were asked to select the face that represents how he/she felt during treatment. 3) Treatment perceptions and opinions: Five-point Likert scales were used to assess parents’ perceptions of their child’s behaviour, comfort during treatment and satisfaction with treatment undertaken and dentists’ ease of treatment provision/ material, patients’ discomfort and the relative time for the procedure. Parents were also asked whether they would choose the same treatment option again, and dentists were asked which treatment option, out with the study, they would have chosen for that tooth. Data analysis Data analyses were performed using the SPSS software for Windows (version 17.0. Chicago, IL, USA: SPSS Inc.). To determine the statistical significance of differences in children’s behaviour and between treatment arms, the data for children’s pain perception, parents’ and dentists’ treatment opinion, differences between younger/older children (3–5/6–8 years), and distribution of ICDAS categories among the groups were analysed using nonparametric Kruskal–Wallis analysis of variance and Bonferroni-corrected Mann–Whitney U-test. For parametric variables (age, d3mft), comparisons were performed using analysis of variance (ANOVA). The level of significance was defined as P < 0.05. Results

From 181 eligible patients, 169 (93%) 3–8year-old children (96 boys and 73 girls) joined in the study. The 12 participating dentists recruited between one and 40 patients over a period of 18 months (4/2011-11/ 2012). There were, therefore, 169 treatment

‘events’ carried out (52 HT, 52, NRCT and 65 CRs). Baseline characteristics of participants and teeth There were no significant differences between the three randomised groups for boy/girl distribution; d3mft values (P = 0.25, CI = 0.25 to 0.27); or ICDAS categories (P = 0.35, CI = 0.35 to 0.70) (Table 1). There was also no significant difference in the overall age of boys (mean = 5.61; SD = 1.49) and girls (mean = 5.49; SD = 1.42; P > 0.05) between the groups. There were differences in the age spread for younger/older children (3–5/6–8 years) between CR group (where 37% were 3–5 years) and the HT group (62% were 3–5 years), P = 0.008 (CI = 0.01 to 0.07) independently comparing two samples with a Bonferroni-corrected Mann–Whitney U-test. First primary molars comprised 69% (116) of the study teeth, and 31% (53) were second primary molars Children’s behaviour Thirty-seven percent of children who received CRs were rated by their dentist as having ‘definitely negative’ or ‘negative’ behaviour, compared with 21% in the NRCT group and 13% in the HT group [P = 0.047, confidence interval (CI) 0.041 to 0.052] (Table 2). This difference was also observed when the younger child age group (3–5 years) was analysed independently; P = 0.044 (CI 0.04–0.05); however, significant differences were not found between groups for the older ages (6–8 years) of children; P = 0.13 (CI 0.12–0.14). Child behaviour was not affected by the dentists’ level of experience (specialists vs. post-graduate students); P = 0.46 (CI = 0.44– 0.47). In the CR group, local anaesthesia was administrated to 52% of the patients. Within this group, the children’s behaviour did not differ significantly between children treated with, and those without, local anaesthesia; P = 0.43 (CI = 0.41–0.44). Pain intensity Regarding pain intensity (Table 3), it was rated as ‘very low’ to ‘low’ in 88% NRCT,

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Caries treatment methods for children: Acceptability

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Table 1. Children’s’ baseline characteristics according to treatment group (n = 169 children). Gender

Age

Tooth of treatment

Group

Boys (%)

Girls (%)

Mean in years (range; SD)

3–5-year olds (%)

6–8-year olds (%)

First primary molars (%)

Second primary molars (%)

d3mft

CR HT NRCT

36 (55) 33 (63) 27 (52)

29 (45) 19 (37) 25 (48)

5.77 (5; 1.32) 5.25 (5; 1.56) 5.62 (5; 1.48)

24* (37) 32* (62) 25 (48)

41* (63) 20* (38) 27 (52)

40 (62) 38 (73) 38 (73)

25 (38) 14 (27) 14 (27)

5.34 5.96 5.58

CR, conventional restorations; HT, hall technique; NRCT, non-restorative caries treatment. Mean number of decay, missing and filled primary teeth (d3mft). *CR-HT, P = 0.008, (CI = 0.01–0.07) Bonferroni-corrected Mann–Whitney U-test. Table 2. Children’s behaviour during treatment (n = 169 children).

Definitely positive Positive Negative Definitely negative Total

Hall technique n (%)

Non-restorative Caries Treatment n (%)

Conventional Restorations n (%)

26 19 7 0 52

22 19 8 3 52

23 18 22 2 65

(50) (37) (13) (0)

(42) (37) (15) (6)

(35) (28) (34) (3)

P-values

P = 0.047* P = 0.013†

*Kruskal–Wallis test for comparison among three groups for negative and definitely negative behaviour combined. †Mann–Whitney U-test for comparison between NRCT and CR for negative and definitely negative behaviour combined. Table 3. Children’s pain perception during treatment (n = 169 children)

Very low Low Moderate Intense Very intense Total

Hall technique n (%)

Non-restorative caries treatment n (%)

Conventional restorations n (%)

28 14 5 3 2 52

34 12 4 0 2 52

38 9 12 2 4 65

(54) (27) (10) (6) (4)

(65) (23) (8) (0) (4)

(58) (14) (18) (3) (6)

P-values P = 0.11*

*Kruskal–Wallis test for comparison among three groups for ‘very low’ and ‘low’ combined.

81% HT, and 72% CR, with no significant differences between the groups; P = 0.11 (CI = 0.10–0.12). Similarly, no significant differences were observed between treatments in younger/older children. Pain intensity was not significantly affected by the dentists’ level of experience. Within the CR group, the use of local anaesthesia did not influence the children’s perception of pain (P = 0.90, CI = 0.89–0.91). Dentists’ opinion Dentists rated each treatment event (n = 169); NRCT (89%); and HT (77%) being ‘very easy’, or ‘easy’ treatments to perform,

while in the CRs group, this was 50% (P < 0.000). Related to procedure duration, most of the dentists considered the NRCT (89%) as a ‘very short’ or ‘short’ procedure to undertake. The distribution of the data is shown in Table 4. When dentists were asked about the treatment option, they would have chosen if the child/ tooth has not been in the study, for each specific case, the majority preferred CR (72%), followed by stainless steel crowns using the conventional technique (17%), with few (7%) considering the NRCT as an alternative treatment, 4% chose another treatment option or did not answer the question, and none of the dentists chose the HT as an option for treatment.

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Table 4. Dentists’ opinion about each treatment (n = 169 treatment events).

Procedure undertaken Very easy Easy Manageable Difficult Very difficult Total Technique difficulty Very easy to handle Easy to handle Manageable Difficult to handle Very difficult to handle Total Treatment duration Very short Short Time-efficient Long Very long Total Child’s level of discomfort No apparent Very mild Mild, significant Moderate Significant, unacceptable Total

Hall technique n (%)

Non-restorative caries treatment n (%)

Conventional restorations n (%)

26 14 8 4 0 52

(50) (27) (15) (8) (0) (100)

31 15 6 0 0 52

(60) (29) (12) (0) (0) (100)

16 16 32 1 0 65

(25) (25) (49) (2) (0) (100)

P < 0.000*

29 12 9 2 0 52

(56) (23) (17) (4) (0) (100)

36 13 3 0 0 52

(69) (25) (6) (0) (0) (100)

17 21 27 0 0 65

(26) (32) (42) (0) (0) (100)

P < 0.000†

24 11 12 5 0 52

(46) (21) (23) (10) (0) (100)

27 19 5 1 0 52

(52) (37) (10) (2) (0) (100)

10 21 28 5 1 65

(15) (32) (43) (8) (2) (100)

P < 0.000‡

21 17 5 9 0 52

(40) (33) (10) (17) (0) (100)

23 21 6 1 1 52

(44) (40) (12) (2) (2) (100)

21 22 17 4 1 65

(32) (34) (26) (6) (2) (100)

P = 0.16

P-values

*,†Kruskal–Wallis test for comparison among three groups for ‘very easy’ and ‘easy’ combined. ‡Kruskal–Wallis test for comparison among three groups for ‘very short’ and ‘short’ combined.

Parents’ perception of child behaviour and comfort None of the parental responses (treatment satisfaction, children’s behaviour/comfort) showed statistically significant differences between the groups. Although, the great majority of parents (>74%) were very satisfied with the procedures and >98% were happy to have the treatment again; 75% rated their child as ‘very comfortable’ with the HT, compared to 65% with CR and 61% with NRCT; however, this did not reach the level of statistical significance (P = 0.46, CI = 0.45–0.48). Children’s behaviour was rated as very good or good by more than 80% of parents. Discussion

This study assessed the acceptability and pain perception of following three caries manage-

ment methods: non-restorative caries treatment (NRCT), hall technique (HT), and conventional restorations (CR) in approximal carious lesions without pulp involvement in primary molars. The main differences observed among the three treatment groups were in dentists’ perception of children’s behaviour, where they reported that children in the HT and NRCT groups responded more favourably compared to those of the CR group. When these differences were analysed independently in the two age groups (3–5 vs 6–8 years), significant differences were still observed only in the younger child age group. This fits with various studies reporting a positive relationship between age and different behavioural aspects related to dental treatment17–19. Younger children show more challenging behaviour during dental treatment compared to older children; however, ability to cope improves as the

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Caries treatment methods for children: Acceptability

child gets older20,21. Furthermore, placing a restoration in a Class II cavity with resin-based materials presents a unique set of challenges for the dentist, including the anaesthetic requirements, moisture control and need for a matrix band, with everything leading towards longer procedure duration, and increased requirements for patient’s cooperation. Therefore, it is not unexpected that the dentists’ perception of children’s behaviour was more favourable with less technique demanding procedures like the HT or NRCT, which also took less time to carry out. Similar results were reported in a randomised clinical trial22 that, among other things, compared the acceptability of the HT with CR for the general practitioners. In this study, the majority of dentists rated the HT (89%) as causing none to mild discomfort for children compared to CR (78%; P = 0.012). An unexpected but interesting finding was that children’s own reports of pain perception did not differ significantly between the three treatment groups, nor was it affected by the dentists’ level of experience. All clinicians were either paediatric dental specialists or post-graduate paediatric trainees, and all treated children on a regular and frequent basis. In addition, trained support staff and designed child-friendly surgeries could have contributed to the children’s positive treatment perception, as has also been suggested in a previous study by Roberts et al.,23 and this included cases where local anaesthesia was required. A cross-sectional study24 analysed the management of fear and dental anxiety in children by general dentists and specialists in paediatric dentistry. This study showed that paediatric dentists routinely used a broader range of behavioural management techniques in order to improve patients’ cooperation, and this positively influences children’s cooperation and reduces dental anxiety during dental treatment. Although there is limited research on the validity and reliability of tools to measure children’s perceptions of dental treatment, dentists have shown to accurately rate children’s discomfort25. The differences in the rating of pain or discomfort between dentists and children might be that children were trying to please the dentists or answering as

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they thought they should because there was a good therapeutic relationship. This was considered a possible problem in one study where children’s pain experience with different gauges of needles was investigated26. The authors stated ‘the vast majority of children rated the injection experience as positive, although there were objective signs of pain like crying’. Additionally, some studies have reported that the assessment of pain intensity by other sources not always correlates highly with children’s self-assessment of pain and it may possibly mirror diverse views of the pain experience27. Favourable clinical results for Stainless Steel Crowns (SSCs) in the primary dentition have led to their wide recommendation as the restoration of choice for multisurface carious primary molars28,29. Still, many dentists avoid the use of SSCs assuming this technique is complex and time-consuming30 or because parents/children might not like the aesthetic results of the crowns31. Interestingly, in our study, an overall good level of acceptance of SSCs was observed with the HT, with 88% of the parents ‘very satisfied’ and rating their child as experiencing great comfort with the technique (75%), which is in agreement with a previous study32. In more than three-quarters (77%) of the treatment events, the dentists rated the HT procedures as ‘very easy’ or ‘easy’ compared to 50% for CRs. The scores were similarly higher for each category, when they were asked about their opinion of the techniques (Table 4). Despite this, none of them said they would choose the HT as an alternative option for any treatment event. Similarly, in very few cases (7%) did the dentists consider NRCT as an option for treatment. The HT was introduced to the clinic and taught to the clinicians as part of this trial, so they were unfamiliar with it. On the other hand, NRCT is a relatively well-known treatment option to many of the dentists in this study. Anecdotally, it seems that the procedure’s limited financial reimbursement by the payment systems outside of the University environment is a disincentive to carry out NRCT and it has not been commonly considered as a definitive treatment itself. Interestingly, fol-

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lowing this trial, the HT and NRCT are both routinely being performed in the paediatric dentistry department at Greifswald University indicating an increase in the level of acceptance and use of these techniques. One of the concerns with the HT has been the occlusal interference33, which did not present as a problem to children in this study. Although it was not possible to standardise a control appointment for the child participants (mainly due to the distances the patients have to travel to reach the clinic) to determine changes in the overbite, all parents were advised to contact the clinic by telephone if a problem with the treated tooth occurred. No parent called and no patient returned with discomfort. Non-restorative caries treatment is an alternative treatment to conventional restorative techniques, which aims to arrest the carious lesion by controlling bacterial plaque7. In this study, NRCT showed an overall good level of acceptance with dentists rating it as the easiest and most time-efficient of the three groups. Furthermore, children’s behaviour was better in the NRCT group when compared to CR, but similar to the HT. In addition, NRCT could also be seen as a childfriendly technique that would let the dentist desensitise especially fearful and anxious children by exposing the child progressively to the treatment, while simultaneously controlling caries lesions. This fits the modern philosophy of minimal intervention simultaneously empowering parents to take responsibility for caries control7. For the HT, 5-year results6 have shown favourable outcomes for pulpal health and restoration longevity. For NRCT, however, there is little data available from observational or recently a clinical study8–10. The high acceptance of alternative treatments like the HT or NRCT offers interesting options for the clinician to discuss with parents and children, but the clinical outcomes must also be evaluated. Conclusion

Children treated with NRCT and the HT showed better behaviour as rated by dentists,

compared to those treated with CR. When children themselves were asked about comfort of the procedure they had undergone, none of the three treatments were rated as less comfortable than another. NRCT and HT were rated as easier to perform, compared to CR (P < 0.000), by dentists. The techniques compared in this study were, generally, viewed favourably by clinicians, children, and their parents. Their clinical effectiveness should be further evaluated.

Why this clinical report is important to paediatric dentists ● To our knowledge, no randomised controlled trial has been published addressing the acceptance and perception/ opinion of non-conventional caries treatment methods in comparison with conventional restorative techniques assessed by children, their parents, and dentists. ● This paper demonstrates the potential of non-conventional methods for approximal carious lesions management for primary molars, in terms of children’s pain perception, parents’, and dentists’ technique acceptability. ● This paper informs clinicians’ expectations of children’s behaviour and pain perception when non-conventional caries treatment methods like the HT and NRCT are performed.

Acknowledgements

We thank the children, their parents, and dentists who took part in this study. This study has been supported by the Paediatric Dentistry Department of Greifswald University, Germany. Conflict of interest

The authors declare no conflict of interest with respect to the conduct, authorship and/ or publication of this article. References 1 van Bochove JA, van Amerongen WE. The influence of restorative treatment approaches and the use of local analgesia, on the children’s discomfort. Eur Arch Paediatr Dent 2006; 7: 11–16. 2 Clinical AAPD. Affairs Committee-Behavior Management Subcommittee; AAPD Council on Clinical Affairs. Guideline on behavior guidance for the pediatric dental patient. Pediatr Dent 2009; 30: 125–133.

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Acceptability of different caries management methods for primary molars in a RCT.

More conservative techniques for managing dental caries including 'partial' and 'no caries removal' have been increasingly of interest...
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