In-situ Evaluation of Anti-caries Technology

Solventum US LLC

Status

Completed

Conditions

Caries

Treatments

Device: MI Paste Plus

Device: Tom's of Maine

Device: Clinpro 5000

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT01650493

CR-11-012

Details and patient eligibility

About

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.

Full 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.

Enrollment

29 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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