A 12-Month Randomized Clinical Trial of 38% SDF vs. Restorative Treatment

Abstract

Purpose The aim of this 2-arm, parallel-group, 12-mo randomized clinical trial was to compare the effectiveness of semiannual application of 38% silver diamine fluoride (SDF) versus restorative treatment (RT) to manage cavitated caries lesions in primary teeth in a diverse population of children in Michigan. Methods Children aged 2 to 10 y with at least 1 soft cavitated lesion (International Caries Detection and Assessment System 5 or 6) with no pain or signs/symptoms of irreversible pulpitis were recruited and randomly assigned to 2 intervention groups. One random lesion per child received 38% SDF (twice, at a 6-mo interval) or RT. All interventions and assessments were done by calibrated dentists. Primary outcome measures were clinical failure rates: minor (e.g., reversible pulpitis, active/soft lesion or progression, restoration loss or need for replacement/repair, secondary caries) and major (e.g., irreversible pulpitis, abscess, extraction). Parent, child, and provider acceptability was also assessed. Results Ninety-eight children were enrolled and randomized, with a mean (SD) age of 4.8 y (1.8); 46% were female and their mean dmft + DMFT was 6.3 (3.9). Sixty-nine children were assessed at 12 mo (sample was within the planned 30% attrition rate). There were significantly more teeth with minor failures (SDF = 65%, RT = 23%, P ≤ 0.001) and major failures (SDF = 13%, RT = 3%, P ≤ 0.001) in the SDF group than the RT group; 74% of SDF-treated lesions were hard at 12 mo vs. 57…