In-situ Evaluation of Anti-caries Technology - Full Text View

Purpose

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.

Condition	Intervention
Caries	Device: Clinpro 5000 Device: MI Paste Plus Device: Tom's of Maine


Study Type:	Observational
Study Design:	Time Perspective: Prospective
Official Title:	In-situ Evaluation of Anti-caries Technology

Resource links provided by NLM:

Drug Information available for: Listerine

U.S. FDA Resources

Further study details as provided by 3M:

Primary Outcome Measures:

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


Enrollment:	29
Study Start Date:	June 2012
Study Completion Date:	July 2013
Primary Completion Date:	May 2013 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Group A Clinpro 5000	Device: Clinpro 5000 Dentrifice containing 950ppm fluoride
Group B MI Paste Plus	Device: MI Paste Plus Dentrifice containing 950ppm fluoride
Group C Toms of Maine	Device: Tom's of Maine Dentrifice that is fluoride free

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


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability Sample

Study Population

Generally healthy subjects in need of a full-coverage crown on a mandibular first or second molar

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01650493

Locations


United States, Iowa
Dows Institute for Dental Research
Iowa City, Iowa, United States, 52242

Sponsors and Collaborators

3M

University of Iowa

Investigators


Principal Investigator:	Clark Stanford, PhD	Dows Institute for Dental Research

More Information


Responsible Party:	3M
ClinicalTrials.gov Identifier:	NCT01650493 History of Changes
Other Study ID Numbers:	CR-11-012
Study First Received:	June 14, 2012
Last Updated:	July 9, 2014

Keywords provided by 3M:


remineralization demineralzation in situ dentrifice

Additional relevant MeSH terms:


Sodium Fluoride Listerine Cariostatic Agents Protective Agents	Physiological Effects of Drugs Anti-Infective Agents, Local Anti-Infective Agents

ClinicalTrials.gov processed this record on May 25, 2017