In-situ Evaluation of Anti-caries Technology

Study Overview
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Brief Summary
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Three toothpastes will be compared, two toothpastes in each subject, to establish whether changes in the depth or area of an artificially created area of tooth decay is the same for each toothpaste.

Detailed Description
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Objective is to evaluate the demineralization and remineralization effects of two experimental fluoride containing dentrifices on enamel and root surface lesions compared with a control dentrifice. Study is a partially randomized, 3-period cross over study involving 30 subjects who need a full-coverage crown on a posterior tooth. Each subject will use each of the study dentrifices over 3 months according to a randomization scheme. Subjects will brush daily with the assigned dentrifice unsupervised. Subjects will each have two provisonal crowns for use during the study. These crowns will contain three hard tooth tissue sections located at interproximal sites. The three tooth tissue slabs will consist of an artificial enamel caries lesion, an artificial root caries lesion, and a sound root. After removal, the tooth slabs will be evaluated using polarized light and photomicrographs for changes in area and depth of lesions.

Official Title
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In-situ Evaluation of Anti-caries Technology

Conditions
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Caries

Intervention / Treatment
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* Device: Clinpro 5000
* Device: MI Paste Plus
* Device: Tom's of Maine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: generally good physical health at least 18 years old needs a full crown on a mandibular first or second molar tooth tooth brushing frequency of twice daily or more agrees not to participate in other clinical study for duration of this study agrees to delay any elective dentistry, including dental prophylaxis, until study complete Exclusion Criteria: any condition requiring antibiotic premedication before a dental procedure active treatment for cancer or seizure disorder diseases or conditions that could interfere with subject safely completing the study currently taking antibiotics or anti-cholinergic medications currently using extensive daily fluoride therapy gross, visible caries chronic use of chlorhexidine within 3 months of baseline use of systemic antibiotics within 7 days of baseline severe periodontal disease use of any fluoride rinses or gels one month prior to study initiation pregnancy, the intention to become pregnant presence of orthodontic bands or removable retainers

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A<br>Clinpro 5000 | Device: Clinpro 5000<br>* Dentrifice containing 950ppm fluoride<br>|
| Group B<br>MI Paste Plus | Device: MI Paste Plus<br>* Dentrifice containing 950ppm fluoride<br>|
| Group C<br>Toms of Maine | Device: Tom's of Maine<br>* Dentrifice that is fluoride free<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in depth of artificial lesion over 3 months | Comparison of two 950 ppm fluoride containing dentrifices, Clinpro Toothcreme and MI Paste Plus, with fluoride-free dentrifice (Toms of Maine)for any change in artificial lesion depth due to demineralization or remineralization over the time period of the study | 3 months | 
| Change in area of artificial lesion over 3 months | Comparison of two 950 ppm fluoride containing dentrifices, Clinpro 5000 and MI Paste Plus, with fluoride-free dentrifice (Toms of Maine) for any change in artificial lesion area due to demineralization or remineralization over time period of study | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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remineralization, demineralzation, in situ, dentrifice