Effectiveness of Silver Diammine Fluoride Applications for Dental Caries Cessation in Tribal Preschool Children in India: Study Protocol for a Randomized Controlled Trial.

introductionSilver Diammine Fluoride (SDF) is an emerging caries preventive treatment option that is inexpensive, safe, and easily accessible. The evidence is clear that the use of SDF at concentrations of 38% is effective for arresting caries in primary teeth. However, the determination of an optimal SDF application frequency for a cavitated lesion in pragmatic settings is warranted especially among high dental caries risk groups. Hence, the primary objective of this clinical trial is to compare the effectiveness of annual, bi-annual, and four times a year application of 38% SDF application in arresting active coronal dentinal carious lesions on primary teeth among tribal preschool children aged 2-6 years. Methods and Analysis: This study is designed as a randomized, controlled trial consisting of three parallel arms with an allocation ratio of 1:1:1. The trial will enroll 480 preschool tribal children with a cavitated carious lesion (2-6 years) attending a primary health care Centre in Wayanad district, India. Each arm will receive 38% SDF application on an annual (baseline), bi-annual (baseline and 6 months), and four times a year (baseline, 2nd, 4th, and 8th week), respectively. The analysis will be performed both at the tooth- and person-level. Ethics and Dissemination: This trial will be conducted following the principles of the Declaration of Helsinki and local guidelines (Indian Council of Medical Research). The protocol has been approved by Institutional Review Committee (IRB). This trial has been registered prospectively with the Clinical Trial Registry of India [Registration No: CTRI/2020/03/024265].