Are RMGIC restorations as effective with or without selective caries removal in primary molars?

Design A two-arm parallel group, tooth-randomised, controlled, non-inferiority clinical trial.Case selection Participants were cooperative 3-9-year-old children of good health, presenting with at least one International Caries Detection and Assessment System (ICDAS) Grade 5 cavitated dentine occlusal carious lesion, with radiographic depth into dentine. Teeth included were symptom-free, non-mobile and had no more than one-third root resorption.Participants were treated and followed-up at The Paediatric Dental Clinic of the Federal University of Rio Grande do Sul, School of Dentistry, Porto Alegre, Brazil. Ethics approval was granted by the Research Ethics Committee of University of Rio Grande do Sul, Brazil.Data analysis In total, 93 children (n = 698 teeth) were evaluated. Clinical examination was performed by two operators, trained and calibrated for caries assessment, for lesion presence and depth. Kappa statistics were used to determine inter-examiner reliability. All participants received standardised toothbrushing instructions, dietary advice and dental prophylaxis before their intervention.Teeth were randomly allocated into one of the two intervention groups using a random number generator. The 'sealing group' had their occlusal lesions sealed with resin-modified glass ionomer cements (RMGIC), without any caries removal, according to manufacturer's instruction. The 'restoration group' had selective caries removal performed with a round, steel bur according to the clinical hardness criteria and were then restored with the same RMGIC as the 'sealing group', again according to manufacturer's instruction. The treatments were performed by two experienced paediatric dental specialists. No local anaesthetic was needed in either group.Patients were followed-up at 6, 12, 18 and 24 months after treatment for examination, prophylaxis and interproximal radiography. Any asymptomatic teeth with marginal deterioration which could be probed underwent reintervention and were maintained in the sample.Cavity volume in the 'restoration group' was statistically significantly greater (p = 0.01) than the 'sealing group'. All other baseline sample characteristics were not significantly different.Results Overall, 68 teeth were included at the start of the study; n = 31 in the 'sealing group' and n = 37 in the 'restoration group'. At one-year post-intervention, 60 teeth were examined. Overall success rate was 59.3% for the 'sealing group' and 78.8% for the 'restoration group'. At two-years post-intervention, 48 teeth were examined. Overall success rate was 48.8% in the 'sealing group' and 76.0% in the 'restoration group'. Over the follow-up period, no radiographic lesion progression was observed in either group.Conclusions Sealing ICDAS Grade 5 occlusal caries with RMGIC without any caries removal resulted in lower survival rates at two-years compared to the same material following selective caries removal.