Randomised clinical trial on caries management options for primary molars: 2-year outcomes

Abstract

The standard surgical approach to treat cavitated carious lesions in children has shown limited effectiveness in controlling the carious process with more conservative techniques involving partial or even no caries removal becoming more commonly used. The aim of this study was to compare the 2-year clinical efficacy and survival rates of three caries treatment approaches: Non-Restorative Caries Treatment (NRCT), the Hall Technique (HT), and Conventional Restorations (CR), for management of occlusoproximal caries lesions (ICDAS 3–5) in primary molars. In this multi-centre, secondary care-based, three-arm parallel-group, randomized controlled trial, 169 children, with one included tooth each, (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 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. Statistical analyses: Non-parametric Kruskal-Wallis analysis of variance, Mann-Whitney U test and Kaplan-Meier survival analyses with Mantel-Cox statistics. 141 children (80.1%) had 23 months minimum follow-up. Patients’ dropouts were censored. Nine patients (6.4%) experienced at least one ‘Major’ failure (irreversible pulpitis, abscess, unrestorable tooth): NRCT 3 (2.1%), CR 5 (3.5%) and HT 1 (0.7%). Twenty-five teeth experienced at least one ‘Minor’ failure (reversible pulpitis, caries progression, and secondary caries): NRCT 9 (6.4%), CR 14 (10%), HT 2 (1.4%). By independently comparing two samples, there was no statistically significant difference in failures between NRCT-CR (p = 0.59, CI = 0.40 to 0.65). Continuing the trend from one-year results, there were still differences between NRCT-HT (p = 0.018, CI = 0.015 to 0.022) and CR-HT (p = 0.004, CI = 0.004 to 0.007). The cumulative survival rate[...].