Evaluation of a Low-fluoride Anticaries Toothpaste
| Tracking Information | |
|---|---|
| First Received Date ICMJE | March 25, 2010 |
| Last Updated Date | June 21, 2011 |
| Start Date ICMJE | September 2010 |
| Primary Completion Date | March 2011 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE | Not Provided |
| Original Primary Outcome Measures ICMJE | Not Provided |
| Change History | Complete list of historical versions of study NCT01094210 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | Not Provided |
| Original Secondary Outcome Measures ICMJE | Not Provided |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | Evaluation of a Low-fluoride Anticaries Toothpaste |
| Official Title ICMJE | Evaluation of a Low-fluoride Anticaries Toothpaste Containing an Innovative Calcium Technology |
| Brief Summary | The purpose of this trial is to evaluate the anticaries remineralizing potential of a toothpaste containing 500 ppm fluoride plus fTCP technology relative to a commercially available toothpaste via a double-blind cross-over in situ (or intra-oral) clinical model, whereby approved human participants will wear an orthodontic appliance fitted with an enamel specimen for the duration of a leg (28 days). There will be two test legs. |
| Detailed Description | Not Provided |
| Study Type ICMJE | Observational |
| Study Design ICMJE | Observational Model: Case-Crossover Time Perspective: Prospective |
| Target Follow-Up Duration | Not Provided |
| Biospecimen | Not Provided |
| Sampling Method | Probability Sample |
| Study Population | This in situ study will recruit 30 adult subjects (between 18-50 years of age). No potential subject will be excluded from this study, regardless of their gender or racial/ethnic origins. However, it is expected that about 18 (60%) of the 30 subjects in the trial will be women. This distribution will allow for meaningful comparisons between gender groups. We will recruit patients attending the clinics of UTHSCSA dental school clinics, which reflect the ethnic mix of the area the clinics serve. However, majority of subjects will be Hispanic due to the high Hispanic prevalence (57.8%) in San Antonio. Thus, minorities will be included at a similar rate to that in the general population attending for dental care, |
| Condition ICMJE | Tooth Abnormality |
| Intervention ICMJE | Drug: Fluorides, Topical
500 ppm F and 1100 ppm F topical toothpastes comprise sodium fluoride in each. |
| Study Group/Cohort (s) |
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| Publications * | Not Provided |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Estimated Enrollment ICMJE | 30 |
| Completion Date | March 2011 |
| Primary Completion Date | March 2011 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria:
|
| Gender | Both |
| Ages | 18 Years to 50 Years |
| Accepts Healthy Volunteers | Yes |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT Number ICMJE | NCT01094210 |
| Other Study ID Numbers ICMJE | 1R43DE020998-01 |
| Has Data Monitoring Committee | Yes |
| Responsible Party | Dr. Bennett T. Amaechi, Associate Professor and Director of Cariology, University of Texas Health Science Center at San Antonio |
| Study Sponsor ICMJE | Indiana Nanotech, LLC |
| Collaborators ICMJE | University of Texas |
| Investigators ICMJE | Not Provided |
| Information Provided By | Indiana Nanotech, LLC |
| Verification Date | June 2011 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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