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

Gingivitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01799226
• Other study ID #: HUM00055445
• Status: Completed
• Phase: N/A
• First received: February 24, 2013
• Last updated: January 11, 2016
• Start date: March 2013
• Est. completion date: December 2013

Study information

• Verified date: January 2016
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor)

Related Conditions & MeSH terms

• Gingivitis

Intervention

Other:
• Toothpaste without triclosan
this intervention will use a toothpaste without triclosan
• Triclosan
this intervention will use Colgate Total which contains triclosan

Locations

Country	Name	City	State
United States	Michigan Center for Oral Health Research	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Unstimulated Whole Saliva Will be Collected for Inflammatory Biomarker Expression.	Inflammatory biomarker expression will be quantified using a custom human 10-complex protein array that is optimized for sensitivity, specificity, stability, and intraassay coefficient of variation by comparing to single cytokine enzyme-linked immunosorbent assays (Quantibody Custom Array, RayBiotech, Norcross, GA).	Baseline to 35 Days	No
Other	Plaque Samples Will be Collected for Bacterial Species Detection.	Supra- and sub-gingival plaque samples will be gently collected using a sterile curet and a one stroke method from two randomized sites within the stent area. The detection of 40 bacterial species will be evaluated by the checkerboard DNA-DNA hybridization technique originally described by Socransky et al. 1994.	Baseline to 35 Days	No
Other	Gingival Crevicular Fluid (GCF) Will be Collected for Inflammatory Biomarker Expression.	A total of 10 biomarkers will be analyzed based on the results from Lee and colleagues: IL-1a, IL-1ß, IL-6, IL-8, IL-10, MCP-1, MMP-8, MMP-9, TIMP-1, and TIMP-2.	Baseline to 35 Days	No
Primary	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	No
Secondary	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	No