In-situ Evaluation of Anti-caries Technology

• ClinicalTrials.gov Identifier: NCT01650493
• Recruitment Status: Completed
• First Posted: July 26, 2012
• Last Update Posted: July 10, 2014
• Sponsor: 3M
• 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
• 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

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

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