Evaluation of Staining Propensity of Silver Diamine Fluoride Withand Without Potassium Iodide in Children (Project Healthy Smiles):Protocol for a Randomized Controlled Trial

Background: Silver diamine fluoride (SDF) is becoming more widely recognized as a simple, cost-effective approach tominimize sensitivity and arrest caries. However, SDF results in caries that are stained black. Potassium iodide (KI) treatmentwith SDF may minimize or lessen the staining. However, the effectiveness of KI on staining has not been investigated. Studiesdemonstrating that potassium iodide reduces the black staining are still insufficient. This paper presents the study protocol forHealthy 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 colorsensor among children aged 4 to 6 years. Another objective of the study is to evaluate the caries-arresting effect of SDF andSDF+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 InternationalCaries Detection and Assessment System (code 1 or above) will be randomly assigned to treatment groups, where group 1 willbe treated with SDF and group 2 will be treated with SDF+KI. Discoloration of treated lesions will be assessed digitally using aNix Mini color sensor. Participants will be followed up at 1, 3, and 6 months after treatment to digitally record the triangle L and triangle Evalues using the Nix Mini color sensor. Data will be analyzed using SPSS (version 28; IBM Corp). Independent sample ttestsand the Mann-Whitney Utest will be used to compare the 2 groups. Results: Enrollment started in October 2023. It is estimated that the enrollment period will be 12 months. Data collection isplanned to be completed in 2024