Clinical trial NCT01650493: In-situ Evaluation of Anti-caries Technology
Official title: In-situ Evaluation of Anti-caries Technology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Caries
Keywords: remineralization
demineralzation
in situ
dentrifice
Lead sponsor: Solventum US LLC
Sponsor class: INDUSTRY
Collaborators: name: University of Iowa
name: 3M
First posted: 2012-07-26
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Generally healthy subjects in need of a full-coverage crown on a mandibular first or second molar

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.

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

Primary outcomes:
measure: Change in depth of artificial lesion over 3 months
timeFrame: 3 months
measure: Change in area of artificial lesion over 3 months
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: Dows Institute for Dental Research
state: Iowa
Study officials:
affiliation: Dows Institute for Dental Research
name: Clark Stanford, PhD
role: PRINCIPAL_INVESTIGATOR
References: