NCT01650493

In-situ Evaluation of Anti-caries Technology

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 29 (actual)
• Sponsor: Solventum US LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Caries

Interventions

Type	Name	Description
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

Timeline

• Start date: 2012-06-01
• Primary completion: 2013-05-01
• Completion: 2013-07-01
• First posted: 2012-07-26
• Last updated: 2024-10-02

Locations

1 site across 1 country: United States