Study of the Anti-Inflammatory Effects of Colgate Total® During an Experimental Gingivitis Model

NCT ID: NCT01799226

Last Updated: 2016-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2013-12-31

Brief Summary

This study evaluates the anti-inflammatory effects of Colgate Total® during an experimental gingivitis model developed by Löe et al. Half of the participants will use Colgate Total® (which contains triclosan), while the other half will use a toothpaste which does not contain triclosan as the control.

Detailed Description

This will be a double-blind. Subjects will be randomly assigned to the test or control dentifrice arm. Enrolled subjects will also be randomly assigned to either right or left side mandibular stent.

During the induction phase (i.e., day 0 to day 21), participants are instructed to refrain from all hygiene procedures in the stent area. During this time period, participants evenly distributed 2mL of their assigned dentifrice into their stent, allowing it to come into contact with the areas of experimental gingivitis for two minutes twice daily while traditional tooth brushing was performed in the non-stent areas. Clinical measures, saliva, gingival crevicular fluid and plaque samples will be collected at days 0, 14, 21, and 35 study visits. A randomization chart will be used to identify which two sites (teeth and tooth surface) will be used at the specific study visit for collection of gingival crevicular fluid(GCF) and plaque.

Conditions

Gingivitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: DOUBLE

Study Groups

Toothpaste without Triclosan

This arm will use a toothpaste that does not contain triclosan

Group Type: ACTIVE_COMPARATOR

Toothpaste without triclosan

Intervention Type: OTHER

this intervention will use a toothpaste without triclosan

Triclosan

This arm will use colgate total which contains triclosan

Group Type: EXPERIMENTAL

Triclosan

Intervention Type: OTHER

this intervention will use Colgate Total which contains triclosan

Interventions

Toothpaste without triclosan

this intervention will use a toothpaste without triclosan

Intervention Type: OTHER

Triclosan

this intervention will use Colgate Total which contains triclosan

Intervention Type: OTHER

Other Intervention Names

Colgate total toothpaste

Eligibility Criteria

Inclusion Criteria

• Race - all
• Gender - female or male
• Age - 18 to 40 years old
• Dentition - minimum of 20 permanent teeth
• Probing Pocket Depth of 1-4mm in all sites
• Mean Clinical Attachment Levels of 2mm on all teeth
• Bleeding Upon Probing of greater than 30% at Day -14 Study Visit
• Consent Form - read, understood, and signed
• Study Procedures - willing to follow all study procedures
• BOP less than 10% at the second assessment visit will be exited from the
• study

Exclusion Criteria

• Medical History - a history of alcoholism or drug abuse
• Diseases of the immune system
• Medical condition that may affect outcome (neurologic or psychiatric disorders, systemic infection
• Medications - chronic medications known to affect the periodontal status (calcium antagonists anticonvulsives, immunosuppressives, anti-inflammatory medications, phenytoin, Depo-Provera contraceptive injection users
• New oral contraceptives users within 3 months of baseline or are planning on starting oral contraceptives during the study
• Hypersensitivity - previous known reaction to or oral allergy to any ingredient in the study toothpaste
• Antibiotics - antibiotic therapy within 3 months of baseline visit
• antibiotic therapy needed for infective endocarditis prophylaxis or total joint replacement
• Use of antiseptics - homecare regime using products to control dental plaque formation within 30 days prior to baseline visit
• Smoking - current smokers, smokers who quit smoking less than one year ago, or a pack-year history of more than or equal to 10 (pack-years will be calculated by multiplying the number of years smoked by the average number of cigarette packs smoked per day)
• Continine - positive urine analysis results
• Current Dental Treatment - orthodontic or periodontal treatment
• Untreated Dental Treatment - untreated carious lesions
• Defective restorations which could exacerbate during a period of oral hygiene abstinence
• Pregnant or women breast-feeding

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Janet Kinney

Assistant Professor of Dentistry, Director of Dental Hygiene Program

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Janet Kinney, MS

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

Michigan Center for Oral Health Research

Ann Arbor, Michigan, United States

Countries

United States

References

Pancer BA, Kott D, Sugai JV, Panagakos FS, Braun TM, Teles RP, Giannobile WV, Kinney JS. Effects of triclosan on host response and microbial biomarkers during experimental gingivitis. J Clin Periodontol. 2016 May;43(5):435-44. doi: 10.1111/jcpe.12519. Epub 2016 Apr 6.

Reference Type: DERIVED

PMID: 26820239 (View on PubMed)

Other Identifiers

HUM00055445

Identifier Type: -

Identifier Source: org_study_id