N/A
N=32
Study of the Anti-Inflammatory Effects of Colgate Total® During an Experimental Gingivitis Model
Gingivitis
Bottom Line
View on ClinicalTrials.gov: NCT01799226 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Jan 2016
Primary outcome: Primary: Change From Baseline in Plaque Index (Silness & Loe 1964) to Day 35 — 0.37; 0.44; 1.24; 1.49 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Toothpaste without triclosan (Other); Triclosan (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Plaque Index (Silness & Loe 1964) to Day 35 |
0.37; 0.44; 1.24; 1.49; 1.84; 1.81 | — |
| SECONDARY Change From Baseline in Gingival Index (Loe & Silness 1963) to Day 35 |
0.25; 0.32; 1.33; 1.38; 1.56; 1.52 | — |
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.
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
- 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
Data sourced from ClinicalTrials.gov (NCT01799226). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.