Pragmatic RCT on the Efficacy of Proximal Caries Infiltration

Abstract

Proximal caries infiltration has been shown to be efficacious in hampering caries lesion progression when performed by dentists working in a university setting. The aim of this randomized split-mouth, placebo-controlled clinical trial was to assess the efficacy of resin infiltration of proximal caries lesions being performed by several dentists in private practices, in combination with individualized oral hygiene plus noninvasive measures compared with these alone. In this study, 87 children and young adults (with 238 pairs of proximal caries lesions radiographically extending into the inner half of the enamel [E2] or the outer third of the dentin [D1]) were randomly allocated to either 1 of 2 treatments. Test lesions were infiltrated, and a mock treatment was performed in control lesions by 5 German private practitioners. All patients received instructions for a noncariogenic diet, flossing and fluoridation, and individualized noninvasive interventions. The primary outcome was radiographic lesion progression (pairwise comparison) evaluated independently by 2 evaluators who were blinded to treatment allocation. After approximately 10 mo (mean ± SD 307 ± 43 d), 92 of 148 lesion pairs in 24 of 38 treated patients who were at high caries risk could be re-evaluated clinically as well as radiographically using individualized bitewing holders, as at baseline; 186 of 204 lesion pairs in 70 of 77 patients (35 of 38 high-risk patients) could be evaluated after 18 mo (mean 542 ± 110 d). No unwanted effects were observed. After 10 mo, progression was recorded in 2 of 92 test lesions (2%) and in 22 of 92 control lesions (24%) (P = 0.001, McNemar/Obuchowski test; relative risk reduction, 91; 95% confidence interval, 62%–98%). After 18 mo, lesion progression was recorded in all included patients in 10 of 186 test lesions (5%) and in 58 of 186 control lesions (31%) (P < 0.001; relative risk reduction, 83; 95% confidence interval, 67%–91%). Thus, resin infiltration seems to be more efficacious in reducing lesion progression compared with individualized noninvasive measures alone over a period of 18 mo when performed in a private practice setting by various practitioners (German Clinical Trials Register / Deutsches Register Klinischer Studien DRKS00009963).