Hydroxyapatite-Fluoride Toothpastes on Caries Activity: A Triple-Blind Randomized Clinical Trial.
Summary
In a triple-blind RCT of 610 preschool children over 24 months, hydroxyapatite-fluoride toothpastes achieved greater inactivation of enamel caries lesions than monofluorophosphate toothpastes. Differences for dentinal lesions were smaller, but the hydroxyapatite group showed more inactivated lesions overall. Both regimens were used three times daily, with 518 completing the trial.
Key Findings
- Triple-blind RCT (n=610; 24 months) compared two HAF toothpastes (1000 and 1450 ppmF) versus two NaMFP controls.
- HAF significantly increased inactivation of enamel lesions versus NaMFP (P<.01); transition from active to inactive status in primary teeth favored HAF (P=.04).
- Dentinal lesion outcomes were similar between groups (P=.08), though HAF showed more inactivated lesions overall; 518 participants completed per-protocol.
Clinical Implications
For children with active caries in primary dentition, hydroxyapatite-fluoride toothpastes may be preferred over monofluorophosphate to promote lesion inactivation and enamel remineralization.
Why It Matters
This large, long-term, triple-blind RCT provides high-level evidence that biomimetic hydroxyapatite-fluoride formulations outperform standard monofluorophosphate in managing active enamel caries in children.
Limitations
- Per-protocol analysis may introduce attrition bias.
- Compliance and diet-related confounders were not detailed; radiographic outcomes were not reported.
Future Directions
Confirm findings with intention-to-treat analyses, include radiographic assessments, microbiome profiling, and cost-effectiveness; evaluate real-world adherence.
Study Information
- Study Type
- RCT
- Research Domain
- Prevention
- Evidence Level
- I - High-quality randomized clinical trial with long-term follow-up
- Study Design
- OTHER