Development and Validation of a Multi-Mineral Fluoride Mouthrinse

Study Overview
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Brief Summary
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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.

Official Title
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Development and Validation of a Multi-Mineral Fluoride Mouthrinse

Conditions
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Dental Caries

Intervention / Treatment
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* Drug: Fluoride
* Drug: Fluoride


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: B<br>226 ppm fluoride + 30 ppm calcium 'prototype/new' mouthrinse | Drug: Fluoride<br>* 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.<br>* Other names: New mouthrinse;|
| Active Comparator: A<br>ADA-accepted over-the-counter 226 ppm fluoride mouthrinse (i.e. ACT, 226 ppm fluoride mouthrinse distributed by Chattem, Inc.) | Drug: Fluoride<br>* 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.<br>* Other names: ACT fluoride mouthrinse;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remineralization of non-cavitated enamel lesions. |  | baseline, 6, 12, 18, 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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remineraliation, pre-existing white-spot (non-cavitated) enamel lesions