In-situ Evaluation of Anti-caries Technology
| Status: | Completed |
|---|---|
| Conditions: | Dental |
| Therapuetic Areas: | Dental / Maxillofacial Surgery |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/18/2012 |
| Start Date: | June 2012 |
| End Date: | July 2013 |
| Contact: | James S Wefel, PhD |
| Email: | james-wefel@uiowa.edu |
| Phone: | 319 335-7376 |
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.
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.
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
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