Caries Clinical Trial
Official title:
In-situ Evaluation of Anti-caries Technology
Verified date | July 2014 |
Source | 3M |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
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.
Status | Completed |
Enrollment | 29 |
Est. completion date | July 2013 |
Est. primary completion date | May 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Dows Institute for Dental Research | Iowa City | Iowa |
Lead Sponsor | Collaborator |
---|---|
3M | University of Iowa |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Primary | 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 | No |
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