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Sponsored by: |
Indiana Nanotech, LLC |
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Information provided by: | Indiana Nanotech, LLC |
ClinicalTrials.gov Identifier: | NCT00642252 |
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.
Condition | Intervention | Phase |
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Dental Caries |
Drug: Fluoride |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Outcomes Assessor), Crossover Assignment |
Official Title: | Development and Validation of a Multi-Mineral Fluoride Mouthrinse |
Estimated Enrollment: | 300 |
Study Start Date: | December 2009 |
Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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B: Experimental
226 ppm fluoride + 30 ppm calcium 'prototype/new' mouthrinse
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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.
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A: Active Comparator
ADA-accepted over-the-counter 226 ppm fluoride mouthrinse (i.e. ACT, 226 ppm fluoride mouthrinse distributed by Chattem, Inc.)
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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.
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Ages Eligible for Study: | 13 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
To participate in this study, panelists will be required to meet the following criteria:
Exclusion Criteria:
Criteria that will not permit participation in this study will be as follows:
Contact: George K Stookey, PhD | 317-278-7877 | gstookey@iupui.edu |
Contact: Robert L Karlinsey, PhD | 317-278-7892 | rkarlins@gmail.com |
United States, Indiana | |
Crispus Attucks Medical Magnet High School | |
Indianapolis, Indiana, United States, 46202 |
Study Director: | George K Stookey, PhD | Indiana Nanotech |
Responsible Party: | Indiana Nanotech ( Dr. Robert L. Karlinsey/Chief Scientific Officer ) |
Study ID Numbers: | Nanotech Phase II April 2008 |
Study First Received: | March 17, 2008 |
Last Updated: | March 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00642252 History of Changes |
Health Authority: | United States: Institutional Review Board |
remineraliation pre-existing white-spot (non-cavitated) enamel lesions |
Calcium, Dietary Tooth Diseases Stomatognathic Diseases Fluorides Dental Caries |
Tooth Diseases Cariostatic Agents Physiological Effects of Drugs Stomatognathic Diseases Fluorides |
Protective Agents Pharmacologic Actions Tooth Demineralization Dental Caries |