Comparison of three management approaches for dental caries in primary molars: A two-year randomized clinical trial

Aim to compare two-year clinical success rates of caries management in children (Hall Technique HT, Nonrestorative caries treatment NRCT, Conventional restorations CR), and to evaluate pain perception, behaviour, technique acceptability by patients, parents and dentists. Methods 122, 3-8-year-olds were enrolled in 2-year parallel group randomised controlled trial (CR, n = 52, HT, n = 35, NRCT, n = 35). Caries was recorded using Nyvad criteria to measure clinical success/ failure rates. Child's pain perception (Visual Analogue Scale of Faces), child behaviour (Frankl scale), parents' and dentists' treatment opinions (5-point Likert scale) were assessed. Statistical analysis included Chi-square, non-parametric Kruskal-Wallis, Bonferroni-corrected Mann-Whitney U tests (p < 0.05), absolute risk reduction (ARR) and number needed to treat (NNT). Results After two years, with 116 participants, clinical success rates were: CR=60.8 % (n = 31), HT=93.8 % (n = 30), NRCT=42.5 % (n = 14) (p < 0.001). Major/minor failure rates differed: CR=17.6 % (n = 9) / 21.6 % (n = 11); HT=6.2 % (n = 2)/ 0 %, NRCT=33.3 % (n = 11)/ 24.2 % (n = 8), (p < 0.05). When comparing HT to CR, ARR = 0.33; NNT= 3 (95 % CI 0.02 -0.58); NRCT to CR, - no observed benefit from NRCT. More than 70 % of children demonstrated "positive/definitely positive" behaviour during treatment. Pain intensity was "very low/low" in 92.3 % of cases for CR, 88.6 % for HT, and 77.1 % for NRCT . NRCT was "very easy" to perform for 82.9 % of participants, compared to 42.3 % for CR and 17.1 % for HT (p < 0.05). CR were reported to take longer than NRCT and HT (p < 0.05). Conclusion Clinical success rates of HT were superior to CR and NRCT. All treatment techniques were well tolerated by children, CR was more time-consuming and HT - technically more difficult to perform. Clinical significance caries management in primary molars can be successfully performed using minimal intervention, particularly, sealing in caries lesions with Hall technique. NRCT can prevent caries progression when adequate access to mechanical plaque disruption and fluoride is provided. However, occasional fluoride application, and uncontrolled toothbrushing with fluoride toothpaste cannot replace restorative procedures.