Expired Study
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Indianapolis, Indiana 46202


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.


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.


Study is Available At:


Original ID:

Nanotech Phase II April 2


NCT ID:

NCT00642252


Secondary ID:


Study Acronym:


Brief Title:

Development and Validation of a Multi-Mineral Fluoride Mouthrinse


Official Title:

Development and Validation of a Multi-Mineral Fluoride Mouthrinse


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

13 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Indiana Nanotech, LLC


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Intervention Model: Crosso


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

30


Enrollment Type:

Actual


Overall Contact Information

Official Name:George K Stookey, PhD
Study Director
Indiana Nanotech

Study Dates

Start Date:January 2012
Completion Date:December 2013
Completion Type:Actual
Primary Completion Date:December 2013
Primary Completion Type:Actual
Verification Date:March 2015
Last Changed Date:March 23, 2015
First Received Date:March 17, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:Remineralization of non-cavitated enamel lesions.
Time Frame:baseline, 6, 12, 18, 24 months
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Fluoride
Description: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.
Arm Name:A
Other Name:ACT fluoride mouthrinse
Intervention Type:Drug
Name:Fluoride
Description: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.
Arm Name:B
Other Name:New mouthrinse

Study Arms

Study Arm Type:Experimental
Arm Name:B
Description:226 ppm fluoride + 30 ppm calcium 'prototype/new' mouthrinse
Study Arm Type:Active Comparator
Arm Name:A
Description:ADA-accepted over-the-counter 226 ppm fluoride mouthrinse (i.e. ACT, 226 ppm fluoride mouthrinse distributed by Chattem, Inc.)

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Indiana Nanotech, LLC
Agency Class:Other
Agency Type:Collaborator
Agency Name:The University of Texas Health Science Center at San Antonio

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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