Effectiveness of silver-di-amine fluoride versus Glass Ionomer Cement for preventing pit and fissure dental caries among institutionalized children in Chandigarh: A randomized controlled trial

Dental caries is a common oral health problem among children, particularly in institutionalized settings where access to preventive dental care is limited. Occlusal pits and fissures of newly erupted permanent molars are especially susceptible to caries during early childhood. Preventive strategies such as silver diamine fluoride and glass ionomer cement pit and fissure sealants are effective; however, evidence comparing their effectiveness in institutionalized children remains limited.

This study is a two-arm parallel randomized controlled trial conducted among institutionalized children aged 6 to 9 years in Chandigarh. Eligible children will be randomly allocated into two groups. In the intervention group, a single application of 38% silver diamine fluoride (SDF) will be applied to the occlusal pits and fissures of permanent molars, with active non-cavitated carious lesions of posterior teeth managed by sealing with SDF, followed by application of 5% sodium fluoride varnish to all teeth at baseline. In the comparator group, glass ionomer cement (GIC) pit and fissure sealants will be placed on the occlusal surfaces of permanent molars, and active carious lesions will be restored using GIC, after which 5% sodium fluoride varnish will be applied to all teeth at baseline.

Sealant placement would be carried out in 166 molar teeth in each group, making a total of 332 teeth (approximately 132 children).  Dental caries status will be assessed using ICDAS II criteria at baseline and at follow-up visits scheduled at 9, 18, and 24 months. The primary outcome will be caries increment on occlusal surfaces of permanent molar teeth. Secondary outcomes will include the cumulative incidence of dental caries in permanent molars and the remaining teeth as assessed using ICDAS II scoring criteria, and also the assessment of glass ionomer cement-based sealants retention using modified Ryge evaluation criteria. Children identified with deep dentinal caries requiring advanced restorative or pulpal care during clinical examination will be referred to the Oral Health Sciences Centre, PGIMER, Chandigarh, and will be offered priority dental care. The findings of this study will help determine whether silver diamine fluoride is as effective as glass ionomer cement pit and fissure sealants in preventing dental caries among institutionalized children. The results may contribute to evidence-based preventive oral health strategies for vulnerable pediatric populations.