Randomised control trial of three caries management methods for primary molars: survival analysis

Abstract

Aim To compare 1-year survival rates of three caries treatment approaches: Non-restorative Caries Treatment (NRCT), the Hall Technique (HT), and Conventional Restorations (CR), for management of Class II caries lesions (ICDAS 3-5) in primary molars. Methods In this multi-centre, secondary care-based, three-arm parallel-group, randomized controlled trial, 169 children (3–8-year-olds; mean = 5.56, SD = 1.45) were allocated to: NRCT (n = 52; opening-up the cavity and applying fluoride), HT (n = 52; sealing in caries with stainless steel crowns without caries removal), CR (n = 65; control arm, complete caries removal and compomer restoration), and treated by 12 paediatric dentists. The primary outcome was treatment failure; caries progression, pulpitis, abscess, pain or treatment replacements. Kaplan-Meier survival analyses with Mantel-Cox statistics, absolute risk reduction (ARR) and numbers-needed-to-treat (NNT) were calculated. Results 148 children (88%) had a minimum follow-up of 11 months. Patients’ dropouts were recorded as censored. Twenty-nine patients (19.6%) experienced at least one failure: NRCT 12 (8.11%), CR 16 (10.81%), HT 1 (< 1%) (p = 0.002, CI = 0.001 to 0.004). Six teeth were extracted: NRCT 3 (2%), CR 3 (2%), HT 0. The cumulative survival rate was 75% for NRCT, 97.7% HT, and 71.4% CR (p = 0.030). Failure rates for CR-HT gave an ARR value of 0.26 (95% CI = 0.14 to 0.39) and NNT of 4, for CR-NRCT: ARR value was 0.04 (95% CI = –0.13 to 0.21) and NNT was 28. Conclusions HT exhibited superior survival rates than NRCT and CR with benefit of no treatment failures, while NRCT and CR failure rates were comparable. This study was funded by Greifswald University/Germany, Paediatric Dentistry Department (Trial registration no. NCT01797458).