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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Gingivitis

Intervention / Treatment
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* Other: Toothpaste without triclosan
* Other: Triclosan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Toothpaste without Triclosan<br>This arm will use a toothpaste that does not contain triclosan | Other: Toothpaste without triclosan<br>* this intervention will use a toothpaste without triclosan<br>|
| Experimental: Triclosan<br>This arm will use colgate total which contains triclosan | Other: Triclosan<br>* this intervention will use Colgate Total which contains triclosan<br>* Other names: Colgate total toothpaste;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Plaque Index (Silness & Loe 1964) to Day 35 | Silness & Loe 1964 is a score of 0-3 with 0 = No plaque, 1 = A film of plaque adhering to free gingival margin and adjacent area of tooth. The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface, 2 = Moderate accumulation of soft deposits within the gingival pocket, or on the tooth and gingival margin, which can be seen with the naked eye, 3 = Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin. This index was used at days 0, 14, 21 and 35. | Baseline to 35 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Gingival Index (Loe & Silness 1963) to Day 35 | Loe & Silness 1963 is a score of 0-3 with 0 = Absence of inflammation, 1 = Mild inflammation, slight change in color and texture, 2 = Moderate inflammation, glazing, redness, edema and hypertrophy, 3 = Severe inflammation, redness and hypertrophy, ulceration. This index was used at days 0, 14, 21 and 35. | Baseline to 35 Days |