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Development and Validation of a Multi-Mineral Fluoride Mouthrinse

NCT00642252 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2015-03-25

No results posted yet for this study

Summary

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.

Conditions

  • Dental Caries

Interventions

DRUG

Fluoride

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.

DRUG

Fluoride

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.

Sponsors & Collaborators

  • The University of Texas Health Science Center at San Antonio

    collaborator OTHER

  • Indiana Nanotech, LLC

    lead OTHER

Principal Investigators

  • George K Stookey, PhD · Indiana Nanotech

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
13 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00642252 on ClinicalTrials.gov