Resin infiltration of proximal caries in primary molars: randomized controlled trial 2-y follow-up

OBJECTIVES: The aim of this split month randomized controlled clinical trial was to evaluate the efficacy of resin infiltration in controlling the progression of non-cavitated proximal lesions in primary molars after two-years follow-up. METHODS: Fifty healthy children presenting at least two primary molars with proximal lesion detected in the radiograph (in the inner half of enamel - E2 or outer third of dentin - D1) were included in the study. The lesions were randomly allocated either to resin infltration (test) or flossing (control). All patients received oral hygiene instructions (brushing and flossing) every 6 months. Caries progression was assessed radiographically by pair-wise reading after 1 year (published previously) and 2 years. McNemar test was used to compare the proportion of caries progression between test and control lesions. Therapeutic effect and relative risk reduction (RRR) were calculated. RESULTS: The sample comprised 28 girls and 22 boys, 6.2 (±1.29) years-old, mainly with moderate or high caries risk (94%). Twenty nine patients were available after 2-years. Caries progression was observed in 24.1% (7/29) of the test lesions, compared with 55.2% (16/29) of the control lesions (p=0.002). In 10 patients (34.5%) only the control lesions progressed, in 6 (20.7%) patients both control and test lesions progressed, and in one patient only the test lesion progressed. The therapeutic effective (absolute value) was 31.1% and RRR was of 56.3%. CONCLUSIONS: In conclusion, after 2 years follow-up, resin infiltration was more efficacious in controlling proximal caries lesions in primary molars than non-invasive approach alone, based on oral higyene intructions every 6 months, in children with moderate to high caries risk.