JMIR Publications

ABSTRACT

Background:

Silver Diamine Fluoride (SDF) is becoming more widely recognized as a simple, cost-effective approach to minimize sensitivity and arrest caries. SDF, on the other hand, results in caries that are stained black. Potassium iodide (KI) treatment with SDF may minimise 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 implementing to compare the staining propensity of silver diamine fluoride (SDF) and silver diamine fluoride with potassium iodide (SDF+KI).

Objective:

This study “Healthy Smiles” aims to evaluate the staining propensity of silver diamine fluoride (SDF) and silver diamine fluoride with potassium iodide (SDF+KI) using Nix Mini colour sensor among children aged 4 to 6 year. Other objective of the study includes to evaluate the caries arresting effect of silver diamine fluoride (SDF) and silver diamine fluoride with potassium iodide (SDF+KI) in the treatment of carious primary teeth.

Methods:

This study is a randomized controlled trial. A total of 60 carious Children who meet the criteria of International Caries Detection and Assessment System (ICDAS) code 1 or above will be randomly assigned to treatment groups where Group I will be treated with SDF while Group II will be treated with SDF/KI. Discolouration of treated lesions will be assessed digitally using a Nix mini colour sensor. Participants will be followed up in the time frame of 1,3, and 6 months post-treatment to digitally record the ∆L and ∆E values using Nix mini colour sensor. Data will be analysed using SPSS Version 28. Independent sample T-test/ Mann -Whitney U test will be used for comparing between two groups.

Results:

Enrollment will start in September 2023. It is estimated that the enrollment period will be 12 months long. Data-collection is planned to be completed in 2024.

Conclusions:

The presented paper describes “Happy smiles” provides an opportunity to address the aesthetic inconvenience of the patients without compromising the effectiveness of the Silver Diamine Fluoride (SDF) treatment. This trial findings will contribute to the limited evidence base related to the discolouration of the Silver Diamine Fluoride (SDF) intervention to improve the aesthetic appearance child oral health. If the results from the trial are promising it will lead to the development of a model for child oral health and pave the way for further research in child oral health. Clinical Trial: This trial is registered on 31st of August 2022 Clinical Trials Registry- India CTRI/2022/08/045133.