Development and Validation of a Multi-Mineral Fluoride Mouthrinse
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00642252 |
Recruitment Status :
Completed
First Posted : March 25, 2008
Last Update Posted : March 25, 2015
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Dental Caries | Drug: Fluoride | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Double (Participant, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Development and Validation of a Multi-Mineral Fluoride Mouthrinse |
Study Start Date : | January 2012 |
Actual Primary Completion Date : | December 2013 |
Actual Study Completion Date : | December 2013 |
Arm | Intervention/treatment |
---|---|
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 |
- Remineralization of non-cavitated enamel lesions. [ Time Frame: baseline, 6, 12, 18, 24 months ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 13 Years to 65 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
To participate in this study, panelists will be required to meet the following criteria:
- Subjects must be 13 - 65 years of age;
- 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;
- Subjects must have a reasonable functional dentition, without a large number of missing teeth, and teeth #'s 22-27 present;
- 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);
- 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;
- 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:
- Any subject who is pregnant or lactating - based on oral interview only - as pregnancy may interfere with the outcome of the study;
- 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;
- 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;
- Any subject who has full dentures, or full orthodontic appliances. No use of nightguards will be permitted during the study period;
- Any subject who uses oral care products (other than those permitted) during the treatment or wash-out periods;
- Any subject with an immunological disorders such as HIV positive, AIDS, and systemic Lupus Erythematosis;
- Any subject concurrently participating in another clinical study;
- Any subject currently taking antibiotics or other medications, which in the opinion of the Investigator/Examiner might influence the study outcome;
- Any subject with a history of sensitivity to oral products or allergies to ingredients in the products;
- Any subject who fails to keep any of their scheduled appointments.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00642252
United States, Indiana | |
Crispus Attucks Medical Magnet High School | |
Indianapolis, Indiana, United States, 46202 |
Study Director: | George K Stookey, PhD | Indiana Nanotech |
Responsible Party: | Dr. Robert L. Karlinsey, Managing Member, Indiana Nanotech, LLC |
ClinicalTrials.gov Identifier: | NCT00642252 History of Changes |
Other Study ID Numbers: |
Nanotech Phase II April 2008 |
First Posted: | March 25, 2008 Key Record Dates |
Last Update Posted: | March 25, 2015 |
Last Verified: | March 2015 |
remineraliation pre-existing white-spot (non-cavitated) enamel lesions |
Dental Caries Tooth Demineralization Tooth Diseases Stomatognathic Diseases |
Fluorides Cariostatic Agents Protective Agents Physiological Effects of Drugs |