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: December 30, 2013
Last verified: December 2013
  Purpose

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 Intervention
Caries
Device: Clinpro 5000
Device: MI Paste Plus
Device: Tom's of Maine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: In-situ Evaluation of Anti-caries Technology

Resource links provided by NLM:


Further study details as provided by 3M:

Primary Outcome Measures:
  • 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


Enrollment: 29
Study Start Date: June 2012
Study Completion Date: July 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Clinpro 5000
Device: Clinpro 5000
Dentrifice containing 950ppm fluoride
Experimental: Group B
MI Paste Plus
Device: MI Paste Plus
Dentrifice containing 950ppm fluoride
Placebo Comparator: Group C
Toms of Maine
Device: Tom's of Maine
Dentrifice that is fluoride free

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01650493

Locations
United States, Iowa
Dows Institute for Dental Research
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
3M
University of Iowa
Investigators
Principal Investigator: Clark Stanford, PhD Dows Institute for Dental Research
  More Information

No publications provided

Responsible Party: 3M
ClinicalTrials.gov Identifier: NCT01650493     History of Changes
Other Study ID Numbers: CR-11-012
Study First Received: June 14, 2012
Last Updated: December 30, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by 3M:
remineralization
demineralzation
in situ
dentrifice

Additional relevant MeSH terms:
Sodium Fluoride
Listerine
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014