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 a cost-effective way to reduce sensitivity and stop cavities, but it causes black staining. Potassium iodide (KI) treatment with SDF may reduce this staining, but its effectiveness has not been well studied.
Objective: The Healthy Smiles study aims to evaluate the staining propensity of SDF and SDF+KI in children aged 4 to 6 years, as well as the caries-arresting effect of these treatments.
Methods: The study involves 60 children with caries who will be randomly assigned to receive either SDF or SDF+KI treatment. Discoloration of the treated lesions will be assessed digitally using a Nix Mini color sensor, with follow-up at 1, 3, and 6 months after treatment. Data will be analyzed using SPSS (version 28; IBM Corp).
Results: Enrollment began in October 2023, with an estimated 12-month enrollment period. Data collection is expected to be completed in 2024.
Conclusions: The Happy Smiles project aims to address the aesthetic inconvenience of patients without compromising the effectiveness of SDF treatment, contributing to the evidence base related to discoloration after SDF intervention in child oral health.
International Registered Report Identifier (IRRID): PRR1-10.2196/51087.
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