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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

Tracking Information
First Submitted Date June 14, 2012
First Posted Date July 26, 2012
Last Update Posted Date July 10, 2014
Study Start Date June 2012
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 25, 2012)
  • 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title In-situ Evaluation of Anti-caries Technology
Official Title In-situ Evaluation of Anti-caries Technology
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.
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 Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Generally healthy subjects in need of a full-coverage crown on a mandibular first or second molar
Condition Caries
Intervention
  • Device: Clinpro 5000
    Dentrifice containing 950ppm fluoride
  • Device: MI Paste Plus
    Dentrifice containing 950ppm fluoride
  • Device: Tom's of Maine
    Dentrifice that is fluoride free
Study Groups/Cohorts
  • Group A
    Clinpro 5000
    Intervention: Device: Clinpro 5000
  • Group B
    MI Paste Plus
    Intervention: Device: MI Paste Plus
  • Group C
    Toms of Maine
    Intervention: Device: Tom's of Maine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 30, 2013)
29
Original Estimated Enrollment
 (submitted: July 25, 2012)
30
Actual Study Completion Date July 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01650493
Other Study ID Numbers CR-11-012
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party 3M
Study Sponsor 3M
Collaborators University of Iowa
Investigators
Principal Investigator: Clark Stanford, PhD Dows Institute for Dental Research
PRS Account 3M
Verification Date July 2014