Development and Validation of a Multi-Mineral Fluoride Mouthrinse
The primary goals of this project are to determine the anticaries benefits of a prototype multi-mineral mouthrinse containing 225 ppm fluoride and 30 ppm of a Ca through the remineralization of enamel white-spots (non-cavitated lesions). The selection of patients with pre-existing white-spot lesions will permit an opportunity to evaluate the efficacy of the multi-mineral mouthrinse in reminerzalizing and/or inhibiting progression of enamel white-spot lesions.
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Development and Validation of a Multi-Mineral Fluoride Mouthrinse|
- Remineralization of non-cavitated enamel lesions. [ Time Frame: baseline, 6, 12, 18, 24 months ] [ Designated as safety issue: No ]
|Study Start Date:||January 2012|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
226 ppm fluoride + 30 ppm calcium 'prototype/new' mouthrinse
Over-the-counter level of fluoride (226 ppm) plus calcium (30 ppm) in a fluoride mouthrinse; FDA considers fluoride in a rinse formulation as a 'drug'; dosage is 10 mL per treatment.
Other Name: New mouthrinse
Active Comparator: A
ADA-accepted over-the-counter 226 ppm fluoride mouthrinse (i.e. ACT, 226 ppm fluoride mouthrinse distributed by Chattem, Inc.)
Over-the-counter level of fluoride (226 ppm) in a fluoride mouthrinse; FDA considers fluoride in a rinse formulation as a 'drug'; dosage is 10 mL per treatment.
Other Name: ACT fluoride mouthrinse
Please refer to this study by its ClinicalTrials.gov identifier: NCT00642252
|United States, Indiana|
|Crispus Attucks Medical Magnet High School|
|Indianapolis, Indiana, United States, 46202|
|Study Director:||George K Stookey, PhD||Indiana Nanotech|