Development and Validation of a Multi-Mineral Fluoride Mouthrinse

Dental Caries Clinical Trial

Official title:

Development and Validation of a Multi-Mineral Fluoride Mouthrinse

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00642252
• Other study ID #: Nanotech Phase II April 2008
• Status: Completed
• Phase: Phase 1
• First received: March 17, 2008
• Last updated: March 23, 2015
• Start date: January 2012
• Est. completion date: December 2013

Study information

• Verified date: March 2015
• Source: Indiana Nanotech, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 13 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dental Caries

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Crispus Attucks Medical Magnet High School	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana Nanotech, LLC	The University of Texas Health Science Center at San Antonio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Remineralization of non-cavitated enamel lesions.		baseline, 6, 12, 18, 24 months	No