Study of the Anti-Inflammatory Effects of Colgate Total® During an Experimental Gingivitis Model
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
|Official Title:||Study of the Anti-Inflammatory Effects of Colgate Total® During an Experimental Gingivitis Model|
- Change From Baseline in Plaque Index (Silness & Loe 1964) to Day 35 [ Time Frame: Baseline to 35 Days ] [ Designated as safety issue: No ]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.
- Change From Baseline in Gingival Index (Loe & Silness 1963) to Day 35 [ Time Frame: Baseline to 35 Days ] [ Designated as safety issue: No ]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.
- Unstimulated Whole Saliva Will be Collected for Inflammatory Biomarker Expression. [ Time Frame: Baseline to 35 Days ] [ Designated as safety issue: No ]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).
- Plaque Samples Will be Collected for Bacterial Species Detection. [ Time Frame: Baseline to 35 Days ] [ Designated as safety issue: No ]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.
- Gingival Crevicular Fluid (GCF) Will be Collected for Inflammatory Biomarker Expression. [ Time Frame: Baseline to 35 Days ] [ Designated as safety issue: No ]A total of 10 biomarkers will be analyzed based on the results from Lee and colleagues: IL-1α, IL-1β, IL-6, IL-8, IL-10, MCP-1, MMP-8, MMP-9, TIMP-1, and TIMP-2.
|Study Start Date:||March 2013|
|Study Completion Date:||December 2013|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Active Comparator: Toothpaste without Triclosan
This arm will use a toothpaste that does not contain triclosan
Other: Toothpaste without triclosan
this intervention will use a toothpaste without triclosan
This arm will use colgate total which contains triclosan
this intervention will use Colgate Total which contains triclosan
Other Name: Colgate total toothpaste
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01799226
|United States, Michigan|
|Michigan Center for Oral Health Research|
|Ann Arbor, Michigan, United States, 48106|
|Principal Investigator:||Janet Kinney, MS||University of Michigan|