Seven-year-efficacy of proximal caries infiltration - Randomized clinical trial

Abstract

Objectives: We report efficacy of resin infiltration to arrest progression of caries lesions as compared with non-invasive measures and oral hygiene education alone after a mean observation time of seven years.

Materials and methods: This randomized split-mouth placebo-controlled clinical trial included 22 young adults having 29 pairs of interproximal non-cavitated caries lesions with radiographic extensions into inner half of enamel (E2) or outer third of dentin (D1). Lesion pairs were randomly allocated to two treatment groups: infiltration (Icon, pre-product; DMG) or mock (control) treatment. All subjects received risk-related instructions for diet, flossing and fluoridation. The primary outcome was radiographic (digital subtraction radiography) lesion progression after seven years. Secondly, Kaplan-Meier-analyses were applied to analyze time-to-failure additionally including patients followed up for less than 54 months as well.

Results: Two lesion pairs were excluded due to invasive treatment decision by another dentist, five lesion pairs were lost to follow-up prior to 54 months but included in the survival analysis. No unwanted effects could be observed. For the primary outcome in 17 patients followed up in mean for 84 months 2/22 infiltrated lesions (9 %) compared with 10/22 control lesions (45 %) progressed (p = 0.018). The relative risk reduction for test in relation to control was 80 % (CI 95 % = 19-95 %). For the survival analysis within a mean (SD) observation time of 73 (25) months mean failure rates of 1.3 % and 7.8 % could be observed for test and controls, respectively. Hazard risk (95 % CI) for caries progression was 6.6 (2-22) for the control compared with the test lesions (p = 0.002).

Conclusions: We conclude that resin infiltration of proximal caries lesions extending radiographically around the enamel dentin junction is efficacious to reduce lesion progression after a mean observation time of seven years.

Clinical significance: This randomized clinical trial proves that caries infiltration is highly efficacious compared with non-invasive measures and oral hygiene education alone after a considerably longer observation time of 7 years than studied so far before.

Keywords: Caries infiltration; Caries lesion; Digital subtraction; Infiltrant; Microinvasive; RCT; Resin.