Clinical trial on restoring untreated and SDF-treated dentine caries lesions

Abstract

Objectives: To investigate the success rate of restoring untreated and SDF-treated dentine caries lesions in primary teeth through atraumatic restorative treatment (ART) approach. Methods: After having obtained parental consent, preschool children with cavitated dentine caries lesions in their primary teeth were randomly allocated to two groups to receive application of either silver diamine fluoride (SDF) solution or placebo (tonic water) on their caries lesions. Ten weeks later, the lesions in both groups were restored using the ART approach in the kindergarten by trained dentists. Clinical examinations were conducted at 6, 12 and 18 months by a blinded independent examiner. A flexible multilevel random effect model using Monte Carlo Markov Chain approach was adopted to investigate the success rate of ART restorations. Results: A total of 194 children (SDF group, 101; control group, 93) participated in this study, with 260 and 249 restorations placed in the SDF and control groups, respectively. The clustering effect on the success rate of restorations in the same child was fairly strong (corr = 0.32). There was no significant difference in ART restoration success rates between the SDF and control groups (grouped proportional hazards model, 95% credible interval included 0). Gender, number of decayed teeth at baseline, education level of parents, oral hygiene habit, operator and cavity size had no significant effect on the restoration success rate. At 18-month follow-up, compared with Class I restorations (SDF group, 79.8%; control group 76.3%), Class V restorations had significantly lower success rates (SDF group, 69.0%; control group 64.1%), followed by Class II (SDF group, 54.7%; control group 48.6%) and Class III (SDF group, 14.1%; control group 9.6%). Conclusions: Prior treatment of dentine caries lesions with SDF does not affect the success rate of ART restorations placed in primary teeth.