Evaluation of Staining Propensity of Silver Diamine Fluoride With and Without Potassium Iodide in Children (Project Healthy Smiles): Protocol for a Randomized Controlled Trial
Abstract
Background Silver diamine fluoride (SDF) is becoming more widely recognized as a simple, cost-effective approach to minimize sensitivity and arrest caries. However, SDF results in caries that are stained black. Potassium iodide (KI) treatment with SDF may minimize or lessen the staining. However, the effectiveness of KI on staining has not been investigated. Studies demonstrating that potassium iodide reduces the black staining are still insufficient. This paper presents the study protocol for Healthy Smiles, a randomized controlled trial implemented to compare the staining propensity of SDF and SDF+KI. Objective This study, Healthy Smiles, aims to evaluate the staining propensity of SDF and SDF+KI using a Nix Mini color sensor among children aged 4 to 6 years. Another objective of the study is to evaluate the caries-arresting effect of SDF and SDF+KI in the treatment of carious primary teeth. Methods This study is a randomized controlled trial. A total of 60 children with caries that meet the criteria of the International Caries Detection and Assessment System (code 1 or above) will be randomly assigned to treatment groups, where group 1 will be treated with SDF and group 2 will be treated with SDF+KI. Discoloration of treated lesions will be assessed digitally using a Nix Mini color sensor. Participants will be followed up at 1, 3, and 6 months after treatment to digitally record the ∆L and ∆E values using the Nix Mini color sensor. Data will be analyzed using SPSS…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 60 participants or records.
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