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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
Sponsor:
Collaborator:
University of Iowa
Information provided by (Responsible Party):
3M

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Caries Device: Clinpro 5000 Device: MI Paste Plus Device: Tom's of Maine

Detailed Description:

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 Design
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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

Resource links provided by the National Library of Medicine

Drug Information available for: Listerine

Groups and Cohorts
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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
 Device: Tom's of Maine
Dentrifice that is fluoride free


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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


Eligibility Criteria
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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
Study Population
Generally healthy subjects in need of a full-coverage crown on a mandibular first or second molar
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Iowa
Dows Institute for Dental Research
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
3M
University of Iowa
Investigators
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Principal Investigator: Clark Stanford, PhD Dows Institute for Dental Research
More Information
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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
Keywords provided by 3M:
remineralization
demineralzation
in situ
dentrifice
Additional relevant MeSH terms:
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Listerine
Sodium Fluoride
Cariostatic Agents
Protective Agents
 Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents