In-situ Evaluation of Anti-caries Technology

Caries Clinical Trial

Official title:

In-situ Evaluation of Anti-caries Technology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01650493
• Other study ID #: CR-11-012
• Status: Completed
• Phase: N/A
• First received: June 14, 2012
• Last updated: July 9, 2014
• Start date: June 2012
• Est. completion date: July 2013

Study information

• Verified date: July 2014
• Source: 3M
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: July 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Caries

Intervention

Device:
• Clinpro 5000
Dentrifice containing 950ppm fluoride
• MI Paste Plus
Dentrifice containing 950ppm fluoride
• Tom's of Maine
Dentrifice that is fluoride free

Locations

Country	Name	City	State
United States	Dows Institute for Dental Research	Iowa City	Iowa

Sponsors (2)

Lead Sponsor	Collaborator
3M	University of Iowa

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in depth of artificial lesion over 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	3 months	No
Primary	Change in area of artificial lesion over 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	3 months	No