Effect of silver diamine fluoride and nano silver fluoride on oral health-related quality of life of children with early childhood caries: A randomized clinical trial.

ABSTRACT

OBJECTIVES: Untreated caries in primary teeth is one of the most prevalent health problems in children worldwide. Silver diamine fluoride (SDF) non-invasively arrests caries but causes staining unlike Nano Silver Fluoride (NSF) which causes no stains. This study compared the effect of NSF and 38 % SDF on the oral health related quality of life (OHRQoL) of preschool children after 6 months. METHODS: Children were included if they were younger than 4 years, with at least one active lesion, ICDAS score ≥3, attending nurseries in a rural area in Alexandria, Egypt. They were randomly assigned to receive NSF once at baseline, or SDF at baseline and after 6 months. The Arabic version of the Early Childhood Oral Health Impact Scale (A-ECOHIS) was used to assess the OHRQoL. The groups were compared using chi-square test and the effect of the intervention on OHRQoL was assessed using multiple linear regression. RESULTS: 360 children were included, mean (SD) age = 42.3 (8.2) months. After 6 months, NSF had significantly lower A-ECOHIS scores than SDF in bivariate analysis (p< 0.05) and in regression analysis (B= -5.02, p = 0.001) after adjusting for confounders. There were significant reductions in the A-ECOHIS total and domains' scores in both study groups, except for the social interaction domain in the SDF group. CONCLUSION: After 6-month, both agents significantly improved children's OHRQoL although NSF had a significantly better impact on OHRQoL than SDF. CLINICAL SIGNIFICANCE: Patient-reported outcomes support the inclusion of the two agents among the options for ECC management with better effect on quality of life after NSF. TRIAL REGISTRATION The trial was registered in the clinicaltrials.gov registry (#NCT05255913).