Randomized Trial of Vitamin D Supplements and Fluoride Treatments for Early Tooth Decay in People Aged 12 to 50

What this Trial Is About

Researchers are investigating the effects of vitamin D supplementation and topical fluoride treatments on people aged 12 to 45 who have vitamin D deficiency and early dental cavities called Initial Carious Lesions ICL. This trial aims to compare how these treatments influence the progression of ICL by measuring changes in the International Caries Detection and Assessment System ICDAS scores, concentrations of proteins in saliva, and the presence of cavity-causing bacteria over six months. The study is conducted as a randomized controlled trial at multiple outpatient centers. Participants are randomly assigned to one of three groups Group A receives vitamin D supplements and oral hygiene instructions Group B receives vitamin D supplements, topical fluoride application, and oral hygiene instructions and Group C, the control group with sufficient vitamin D levels, receives topical fluoride and oral hygiene instructions. Vitamin D supplements include weekly 50,000 IU doses for two months followed by daily maintenance doses of 5,000 IU for one month. Fluoride treatments involve professional application of 5% sodium fluoride gel for five minutes on affected teeth. During the six-month study, participants will have their dental health monitored through assessments of their ICDAS scores, saliva samples analyzed for protein levels using ELISA, and bacterial counts measured by PCR techniques. Researchers will also check serum vitamin D levels. Oral hygiene and diet counseling are provided. The study evaluates the progression of initial cavities, changes in saliva biomarkers, and oral bacteria to understand how these interventions impact dental caries management.

A Randomized Controlled Trial of Vitamin D Supplementation on Salivary Biomarkers and Cariogenic Oral Microbiome