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Development and Validation of a Multi-Mineral Fluoride Mouthrinse

This study has been terminated.
Sponsor:
Information provided by:
Indiana Nanotech, LLC
ClinicalTrials.gov Identifier:
NCT00642252
First received: March 17, 2008
Last updated: June 21, 2011
Last verified: June 2011
History of Changes
  Purpose

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
Dental Caries
 Drug: Fluoride
 Phase 1

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Indiana Nanotech, LLC:

Primary Outcome Measures:
  • Remineralization of non-cavitated enamel lesions. [ Time Frame: baseline, 6, 12, 18, 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: January 2012
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: B
226 ppm fluoride + 30 ppm calcium 'prototype/new' mouthrinse
 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.
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.)
 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.
Other Name: ACT fluoride mouthrinse

  Eligibility

Ages Eligible for Study:   13 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

To participate in this study, panelists will be required to meet the following criteria:

  1. Subjects must be 13 - 65 years of age;
  2. Subjects must read and sign the Informed Consent prior to initiation of study procedures. All subjects will receive a copy of the signed Informed Consent;
  3. Subjects must have a reasonable functional dentition, without a large number of missing teeth, and teeth #'s 22-27 present;
  4. Have normal salivary gland function (unstimulated whole salivary flow rate equal to or greater than 0.25 ml/min and paraffin stimulated whole salivary flow rate equal to or at least 1.0 ml/min);
  5. Subjects must be willing to participate in the study, be able to follow the study directions, be willing to return for all specified visits at their appointed time, and to use the product as per instructions;
  6. Subjects must be in good general health based on medical history and oral soft and hard tissue examination.

Exclusion Criteria:

Criteria that will not permit participation in this study will be as follows:

  1. Any subject who is pregnant or lactating - based on oral interview only - as pregnancy may interfere with the outcome of the study;
  2. Any subject who has a systemic health condition such as diabetes that could affect the outcome of the study at the discretion of the examiner;
  3. Any subject who has an oral condition, such as excessive, untreated dental caries, periodontal disease, chronic dental neglect, or any oral pathology including xerostomia determined by oral examination and subject history that in the opinion of the dental examiner could affect the outcome of the study;
  4. Any subject who has full dentures, or full orthodontic appliances. No use of nightguards will be permitted during the study period;
  5. Any subject who uses oral care products (other than those permitted) during the treatment or wash-out periods;
  6. Any subject with an immunological disorders such as HIV positive, AIDS, and systemic Lupus Erythematosis;
  7. Any subject concurrently participating in another clinical study;
  8. Any subject currently taking antibiotics or other medications, which in the opinion of the Investigator/Examiner might influence the study outcome;
  9. Any subject with a history of sensitivity to oral products or allergies to ingredients in the products;
  10. Any subject who fails to keep any of their scheduled appointments.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00642252

Locations
United States, Indiana
Crispus Attucks Medical Magnet High School
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana Nanotech, LLC
Investigators
Study Director: George K Stookey, PhD Indiana Nanotech
  More Information

No publications provided

Responsible Party: Dr. Robert L. Karlinsey/Chief Scientific Officer, Indiana Nanotech
ClinicalTrials.gov Identifier: NCT00642252     History of Changes
Other Study ID Numbers: Nanotech Phase II April 2008
Study First Received: March 17, 2008
Last Updated: June 21, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana Nanotech, LLC:
remineraliation
pre-existing white-spot (non-cavitated) enamel lesions

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Fluorides
 Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013