ART/Hall Technique for Primary Molar Multisurface-cavities: 30-Month RCT Results

Objectives: Cavitated occluso-proximal carious lesions in primary molars are common but it is challenging to achieve consistently good outcomes using minimally invasive treatments.This two-arm, parallel group, patient-randomized controlled, superiority trial set in schools, compared survival rates using Atraumatic Restorative Treatment (ART; control group) with the Hall Technique (HT; experimental group).
Methods: Children aged 5-10 years were screened at schools (Tietê, Brazil). If they fitted the inclusion criteria (at least one occluso-proximal dentin lesion in a primary molar) and their parents consented to participate, they were recruited (n=131). One tooth per child was randomly allocated to receive either: ART using GIC (Equia Forte, GC Corp.) or HT. The primary outcome was survival rate, a composite measure of absence of Minor Failures (restoration/crown defect, but not interfering with tooth health) and Major Failures (signs/ symptoms of irreversible pulp damage, e.g. dental fistula/abscess, tooth fracture or failures that cannot be repaired). Kaplan-Meier and log rank tests were carried out for survival analysis. Cox regression investigated associations between the primary outcome and age, sex, surface, dmft/DMFT, side, arch, contamination, tooth or operator (α= 5%).
Results: After 30 months, 103/131 (79%) children were followed-up. A total of 33 failures were observed in the ART group and 2 in the HT group (Minor; 28 ART: 1 HT and Major; 5 ART: 1 HT). The treatment survival were 30.8% for ART and 93.4% for HT. The HT had a statistically significantly higher survival rate than ART (HR=17.45; p<0.001, CI=4.17-73.12). Cox regression found no association between restoration survival and the variables tested.
Conclusions: Occluso-proximal dentin lesions in primary molars treated using the HT had higher survival rates than ART after 30 months. (Local Ethics Committee: #1.293.935; ClinicalTrials.gov: NCT02569047).