In-situ Evaluation of Anti-caries Technology

This study has been completed.
Sponsor:
Collaborator:
University of Iowa
Information provided by (Responsible Party):
3M
ClinicalTrials.gov Identifier:
NCT01650493
First received: June 14, 2012
Last updated: July 9, 2014
Last verified: July 2014

June 14, 2012
July 9, 2014
June 2012
May 2013   (final data collection date for primary outcome measure)
  • Change in depth of artificial lesion over 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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
Same as current
Complete list of historical versions of study NCT01650493 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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In-situ Evaluation of Anti-caries Technology
In-situ Evaluation of Anti-caries Technology

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.

Observational
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

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

Caries
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
29
July 2013
May 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01650493
CR-11-012
No
3M
3M
University of Iowa
Principal Investigator: Clark Stanford, PhD Dows Institute for Dental Research
3M
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP