Twelve-month randomized controlled trial of 38% silver diamine fluoride with or without potassium iodide in indirect pulp capping of young permanent molars.

Background: The clinical and radiographic effectiveness of 38% silver diamine fluoride (SDF) with and without potassium iodide (KI) was tested and compared with resin-modified glass ionomer cement (RMGIC) in indirect pulp capping of deep carious lesions in young permanent molars.

Methods: One hundred eight permanent first molars with deep occlusal cavitated carious lesions in 49 children aged 6 through 9 years were randomly allocated into 3 groups (n = 36 molars per group) and treated with SDF plus KI, SDF, and RMGIC. RMGIC was used as a base and a resin-based composite restoration followed. Clinical assessments for secondary caries (primary outcome), postoperative pain, tooth vitality, and restoration success and quality rates according to Modified US Public Health Service and Ryge Criteria for Direct Clinical Evaluation of Restorations were performed after 3, 6, and 12 months. Periapical radiographs were obtained at baseline, 6 months, and 12 months. Outcomes were assessed using mixed effects multilevel logistic and linear regression analyses.

Results: There were no significant differences (P = .26) among the groups at all times for secondary caries, postoperative pain, tooth vitality, clinical abscess, radiographic signs of pulpal pathology, restorations' marginal adaption, anatomic form, and surface roughness. There was a significant difference (P = .03) in restoration color, marginal staining, and luster. The RMGIC group outperformed the 2 SDF groups in color and luster.

Conclusions: The authors did not find differences among the groups in preventing secondary caries or pain or in maintaining pulpal health. The RMGIC group had better restoration color and luster than both SDF groups and better marginal staining than the SDF group.

Practical Implications: The results of this study can help guide treatment decision making regarding use of SDF and SDF plus KI as indirect pulp capping materials in deep cavitated lesions. This clinical trial was registered at ClinicalTrials.gov. The registration number is NCT04236830.