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% at 6 mo. Providers stated that SDF was easier, faster, and more preferable than RT ( P ≤ 0.001). No significant differences were found in parental satisfaction and acceptability. At 12 mo, children in the RT arm felt significantly ( P < 0.05) happier with their tooth appearance and stated that their visit to the dentist hurt less. Conclusion: At 12 mo, SDF-treated lesions had significantly more minor and major failures than RT, suggesting that SDF-treated teeth need to be closely monitored in a population at high caries risk (ClinicalTrials.gov NCT02601833). Knowledge of Transfer Statement: The results of this study can be used by clinicians when deciding whether to restore or apply silver diamine fluoride to cavitated lesions in primary teeth. Information on treatment outcomes and parent, child, and provider acceptability can help guide appropriate treatment decisions and need for monitoring.

Silver Diamine Fluoride in Pediatric Dentistry: Effectiveness in Preventing and Arresting Dental Caries—A Systematic Review

“…The collected data suggest that the 38% SDF solution is effective in preventing and arresting carious enamel and dentin lesions affecting permanent molars, including those with structural enamel defects such as MIH, in patients aged 1 to 13 years [49,57,82]. SDF had a preventive effect on 6-year-old molars with MIH; no new carious lesions appeared after SDF application) [36].…”

“…In Brazil, two studies explored the effectiveness of 30% SDF in arresting caries affecting molars [55,56]. In Turkey, the study performed by Ballikaya et al, investigated the potential of 38% SDF in the treatment of incipient carious lesions of permanent molars affected by hypomineralization within the syndrome of molars and incisors hypomineralization (MIH) [57].…”

“…The final results show that eight studies have a high risk of bias, two have a very high risk of bias and four have a low risk of bias [63]. [8,11,[43][44][45][46][47][48][49][50][51][52][53][54][55][56][57][58]60,61,64].…”

“…During repeated applications of Riva Star© 38% SDF at 1, 6 and 12 months involving 106 permanent molars with MIH hypomineralization and ICDAS lesions 1-2, Ballikaya E. et al, 2021, did not note a significant difference in hypersensitivity scores between the group who received, following the application of SDF, potassium iodide (KI) and the one who participated to an atraumatic restorative treatment modified with silver and accompanied by a hybrid glass ionomer cement (GIC) filling. Nevertheless, the results were more promising for the occlusal surfaces than for the palatine surfaces where the cumulative efficiency rates were 88.7% and 58.8% [57,65].…”

“…This semi-annual recourse to 38% SDF does not necessarily prevent the clinician from minor or even major failures, especially in high caries risk children, suggesting that the lesions treated by SDF must be correctly monitored [57,93].…”