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

University of Michigan

Status

Completed

Conditions

Gingivitis

Treatments

Other: Toothpaste without triclosan

Other: Triclosan

Study type

Interventional

Funder types

Other

Identifiers

NCT01799226

HUM00055445

Details and patient eligibility

About

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.

Full 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.

Enrollment

32 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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
At Day 0 Study Visit, all subjects must have a BOP of less than 10%. Subjects not meeting the BOP study criteria will be asked to return in 2 weeks for a second assessment visit. Subjects who do not meet the inclusion criteria
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