A fluoride dose-response evaluation in an anticaries clinical trial

Area of Science:

• Dental Public Health
• Fluoride Chemistry
• Pediatric Dentistry

Background:

• Dental caries remains a significant public health issue globally.
• Fluoride is a well-established agent for caries prevention.
• Optimizing fluoride concentration in dental products is crucial for maximizing efficacy and safety.

Purpose of the Study:

• To evaluate the dose-response relationship between increasing levels of sodium monofluorophosphate (MFP) and dental caries increments in schoolchildren.
• To determine the optimal effective concentration of MFP for caries prevention.
• To assess the safety profile of different MFP concentrations.

Main Methods:

• A cohort of 4424 schoolchildren participated in the study.
• Four increasing levels of fluoride (1000 to 2500 ppm F) as MFP were evaluated.
• Dental caries increments were measured over three years using DMFS, DMFT, and DFS-A indices.
• Statistical models controlled for age and baseline DMFS as covariates.

Main Results:

• Consistent linear decreases in DMFS, DMFT, and DFS-A were observed with increasing MFP concentrations up to 2500 ppm F.
• Average reductions per 1000 ppm F increase were 0.32 in DMFS, 0.13 in DMFT, and 0.17 in DFS-A (p < 0.03).
• For children aged 11 and older, caries reduction slopes quadrupled (p < 0.01).
• No significant differences in adverse reactions or safety issues were noted across different dose levels.

Conclusions:

• Increasing MFP fluoride concentration up to 2500 ppm F provides a dose-dependent reduction in dental caries in schoolchildren.
• Higher MFP concentrations are more effective, particularly in older children.
• MFP at these concentrations is safe and well-tolerated for caries prevention.