Use of rubber dam versus cotton roll isolation on composite resin restorations’ survival in primary molars: 2-year results from a non-inferiority clinical trial

Background: This non-inferiority randomised clinical trial aimed to evaluate the survival of direct bulk fill composite resin restorations in primary molars using different methods of moisture control: rubber dam isolation (RDI—local anaesthesia and rubber dam) and cotton roll isolation (CRI—cotton roll and saliva ejector). Secondary outcomes included baseline and 2-year incremental cost, self-reported child’s pain scores and patient behaviour during the restorative procedure. Methods: A total of 174 molars (93 children) with dentine caries lesions were randomly allocated to study groups (RDI or CRI) and restored with bulk fill composite resin by trained operators. Two blinded examiners assessed the restorations for up to 24 months. Wong-baker faces and Frankl's behaviour rating scales were used for accessing the child's pain and behaviour, respectively. The primary outcome (restoration survival) was analysed using the two-sample non-inferiority test for survival data using Cox Regression (non-inferiority/alternative hypothesis HR > 0.85; CI = 90%). Bootstrap Linear regression was used for cost analysis and logistic regression for pain and behaviour analysis (α = 5%). Results: After 2-years, 157 restorations were evaluated (drop-out = 9.7%). The survival rate was RDI = 60.4% and CRI = 54.3%. The non-inferiority hypothesis was accepted by the Cox Regression analysis (HR = 1.33; 90% CI 0.88–1.99; p = 0.036). RDI was 53% more expensive when compared to the CRI group. No differences were found between the groups regarding pain (p = 0.073) and behaviour (p = 0.788). Conclusion: Cotton roll isolation proved to be non-inferior when compared to rubber dam for composite restorations longevity in primary molars. Furthermore, the latest presented the disadvantage of higher cost and longer procedure time. Clinical Significance The moisture control method does not influence the longevity of composite restorations in primary molars. Cotton roll isolation proved to be non-inferior to rubber dam isolation and is a viable option for restoring primary molars. Clinical trial registration registered NCT03733522 on 07/11/2018. The present trial was nested within another clinical trial, the CARies DEtection in Children (CARDEC-03-NCT03520309)

Glass Ionomer Sealants Can Prevent Dental Caries but Cannot Prevent Posteruptive Breakdown on Molars Affected by Molar Incisor Hypomineralization: One-Year Results of a Randomized Clinical Trial

To evaluate the preventive effect of glass ionomer cement (GIC) against dental caries and posteruptive breakdown (PEB) on molars affected by molar incisor hypomineralization (MIH). In this randomized clinical trial, 77 children aged 5-9 years with at least 1 MIH-affected molar and without PEB or dentin caries lesions (n = 228) were included and randomly allocated to one of the following groups: (1) MIH-affected molars that remained unsealed and (2) MIH-affected molars that received GIC sealants. Dental caries and PEB were clinically evaluated after 6 and 12 months. Associations between dental caries and PEB with independent variables were evaluated using logistic regression analysis (p < 0.05). The MIH-affected molars allocated to the GIC sealant group were less likely to develop dental caries compared to those allocated to the unsealed group (OR = 0.23; 95% CI 0.06-0.95). Conversely, application of a GIC sealant was not associated with prevention of PEB (p = 0.313). Furthermore, MIH-affected molars presenting yellow-brown opacities were almost 5 times more likely to develop dental caries (p = 0.013) and PEB (p = 0.001) compared to those presenting white-creamy opacities. We can conclude that GIC sealants can prevent dental caries on MIH-affected molars; however, the same protective effect was not observed for PEB