In-situ Evaluation of Anti-caries Technology
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ClinicalTrials.gov Identifier: NCT01650493 |
Recruitment Status :
Completed
First Posted : July 26, 2012
Last Update Posted : July 10, 2014
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Condition or disease | Intervention/treatment |
---|---|
Caries | Device: Clinpro 5000 Device: MI Paste Plus Device: Tom's of Maine |
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.
Study Type : | Observational |
Actual Enrollment : | 29 participants |
Time Perspective: | Prospective |
Official Title: | In-situ Evaluation of Anti-caries Technology |
Study Start Date : | June 2012 |
Actual Primary Completion Date : | May 2013 |
Actual Study Completion Date : | July 2013 |

Group/Cohort | Intervention/treatment |
---|---|
Group A
Clinpro 5000
|
Device: Clinpro 5000
Dentrifice containing 950ppm fluoride |
Group B
MI Paste Plus
|
Device: MI Paste Plus
Dentrifice containing 950ppm fluoride |
Group C
Toms of Maine
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Device: Tom's of Maine
Dentrifice that is fluoride free |
- Change in depth of artificial lesion over 3 months [ Time Frame: 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
- Change in area of artificial lesion over 3 months [ Time Frame: 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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
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

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): NCT01650493
United States, Iowa | |
Dows Institute for Dental Research | |
Iowa City, Iowa, United States, 52242 |
Principal Investigator: | Clark Stanford, PhD | Dows Institute for Dental Research |
Responsible Party: | 3M |
ClinicalTrials.gov Identifier: | NCT01650493 |
Other Study ID Numbers: |
CR-11-012 |
First Posted: | July 26, 2012 Key Record Dates |
Last Update Posted: | July 10, 2014 |
Last Verified: | July 2014 |
remineralization demineralzation in situ dentrifice |
Listerine Sodium Fluoride Cariostatic Agents Protective Agents |
Physiological Effects of Drugs Anti-Infective Agents, Local Anti-Infective Agents |