In-situ Evaluation of Anti-caries Technology

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

University of Iowa

Information provided by (Responsible Party):

ClinicalTrials.gov Identifier:

NCT01650493

First received: June 14, 2012

Last updated: January 28, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

June 14, 2012

Last Updated Date

January 28, 2013

Start Date ^ICMJE

June 2012

Estimated Primary Completion Date

July 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change in depth of artificial lesion over 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01650493 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

In-situ Evaluation of Anti-caries Technology

Official Title ^ICMJE

In-situ Evaluation of Anti-caries Technology

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Caries

Intervention ^ICMJE

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

Study Arm (s)

Experimental: Group A
Clinpro 5000

Intervention: Device: Clinpro 5000
Experimental: Group B
MI Paste Plus

Intervention: Device: MI Paste Plus
Placebo Comparator: Group C
Toms of Maine

Intervention: Device: Tom's of Maine

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

November 2013

Estimated Primary Completion Date

July 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01650493

Other Study ID Numbers ^ICMJE

CR-11-012

Has Data Monitoring Committee

Responsible Party

Study Sponsor ^ICMJE

Collaborators ^ICMJE

University of Iowa

Investigators ^ICMJE

Principal Investigator:

Clark Stanford, PhD

Dows Institute for Dental Research

Information Provided By

Verification Date

January 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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