Clinical trial NCT01799226: Study of the Anti-Inflammatory Effects of Colgate Total® During an Experimental Gingivitis Model
Official title: Study of the Anti-Inflammatory Effects of Colgate Total® During an Experimental Gingivitis Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingivitis
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2013-02-26
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

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

Primary outcomes:
measure: Change From Baseline in Plaque Index (Silness & Loe 1964) to Day 35
timeFrame: Baseline to 35 Days
Secondary outcomes:
measure: Change From Baseline in Gingival Index (Loe & Silness 1963) to Day 35
timeFrame: Baseline to 35 Days
Other outcomes:
measure: Unstimulated Whole Saliva Will be Collected for Inflammatory Biomarker Expression.
timeFrame: Baseline to 35 Days
measure: Plaque Samples Will be Collected for Bacterial Species Detection.
timeFrame: Baseline to 35 Days
measure: Gingival Crevicular Fluid (GCF) Will be Collected for Inflammatory Biomarker Expression.
timeFrame: Baseline to 35 Days
Locations:
city: Ann Arbor
country: United States
facility: Michigan Center for Oral Health Research
state: Michigan
Study officials:
affiliation: University of Michigan
name: Janet Kinney, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.