Evaluation of Oral Hygiene Products in an In Situ Caries Model

Summary

The study will evaluate and compare the potential anti-caries efficacy of a test regimen: placebo (fluoride free) toothpaste (twice daily use) plus fluoride mouthwash (once daily use), in comparison with brushing with a placebo toothpaste alone (twice daily use), to remineralize previously demineralized enamel specimens, as measured by Surface MicroHardness Recovery (%SMHR). This will be a single center, randomized, laboratory analyst blinded, placebo, four treatment, cross-over study in healthy participants. Participants will be assessed at baseline and at the beginning and end of each treatment visit to monitor clinical efficacy and safety.

Timeline

Start

2015-04

Primary completion

2015-07

Completion

2015-08

Outcome

Met primary endpoint

registry p <0.0001; Mean Difference (Net) 16.76 (95% CI 11.061 to 22.454); ANCOVA NCT02399163 ↗

Drugs

Indications