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

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.

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