To evaluate the efficacy of 38 percent Silver diamine fluoride along with atraumatic restorative technique in arresting caries among secondary school children in rural Telangana: A Randomized controlled trial

Dental caries in the school children population is a big concern as it escalate oral health burden in communities. It require preventive and therapeutic treatment that are generally neglected in rural communities. Atraumatic restorative technique (ART) is a WHO recommended treatment procedure in rural areas or poor countries lacking sufficient infrastructure for providing dental care. It has been a successful community-based approach to reduce the burden of dental caries which involves removal of caries with hand instruments only without the use of drilling machines followed by placement of suitable restorative materials. Recently, a novel technique has been introduced as silver modified ART in which 38% silver diamine fluoride (SDF) is applied first for arresting carious lesions followed by placement of suitable restoration. It serves as a preventive and restorative procedure to regain the function of the permanent dentition. The aim of this study is to evaluate caries arresting efficacy of the novel technique (SDF application with ART), in comparison with ART alone, for treatment of cavitated proximal carious lesions in a rural community setting. Outcome of this study may improve the optimal dental care in rural settings which lack access to comprehensive dental care.

 Methods and Analysis:

This study will be conducted in secondary school children (12-15yrs) population of rural areas (Yadadri, Bhongir district) of Telangana state. Whole district will be divided into 5 zones (North, East, West, South, Central ) and two school from each zone of the district will be selected following multistage stratified sampling procedures. A total of 10 school will be selected to carry out the study. After clinical and radiographic examination individuals with cavitated proximal carious lesion in mandibular molars indicated for ART restoration will be selected for the study. Consent will be obtained from all the participants before the procedure. A total sample size of 240 will be selected for the study. This study will be a randomized, controlled trial with a 1:1 allocation ratio in two parallel groups. Study arm 1 will receive ART only, and study arm 2 will receive 38% SDF application and ART only. A digital radiograph will be taken immediately after restoration (baseline) as well as at the end of the 1 year for evaluation of caries arrest. The assessment of the survival of the restoration will be done at 1 week, 6 month and 1 year. The primary outcome of this study will be to assess the arrest/reversal of existing cavitated carious lesions and to identify secondary carious lesion around the intervention surface. Secondary outcomes included adverse events, such as nausea, fluorosis, vomiting, allergic reactions, staining, tooth sensitivity, soft tissue trauma, symptomatic progression, pulpal health, lack of retention (for ART).