Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
29 participants
OBSERVATIONAL
2012-06-30
2013-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Group A
Clinpro 5000
Clinpro 5000
Dentrifice containing 950ppm fluoride
Group B
MI Paste Plus
MI Paste Plus
Dentrifice containing 950ppm fluoride
Group C
Toms of Maine
Tom's of Maine
Dentrifice that is fluoride free
Interventions
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Clinpro 5000
Dentrifice containing 950ppm fluoride
MI Paste Plus
Dentrifice containing 950ppm fluoride
Tom's of Maine
Dentrifice that is fluoride free
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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University of Iowa
OTHER
3M
INDUSTRY
Solventum US LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Clark Stanford, PhD
Role: PRINCIPAL_INVESTIGATOR
Dows Institute for Dental Research
Locations
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Dows Institute for Dental Research
Iowa City, Iowa, United States
Countries
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Other Identifiers
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CR-11-012
Identifier Type: -
Identifier Source: org_study_id
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