Study of the Anti-Inflammatory Effects of Colgate Total® During an Experimental Gingivitis Model
The overall objective of this proposal is to examine 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: Single Blind (Outcomes Assessor)
|Official Title:||Study of the Anti-Inflammatory Effects of Colgate Total® During an Experimental Gingivitis Model|
- anti-inflammatory effects [ Time Frame: 21 days ] [ Designated as safety issue: No ]The following ten biomarkers will be analyzed in saliva and Gingival crevicular fluid: IL-1α, IL-1β, IL-6, IL-8, IL-10, MCP-1, MMP-8, MMP-9, TIMP-1, TIMP-2.
- clinical measures [ Time Frame: 21 days ] [ Designated as safety issue: No ]Plaque and gingival indices will be monitored
|Study Start Date:||March 2013|
|Estimated Study Completion Date:||June 2014|
|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, parallel group study utilizing the experimental gingivitis model. Subjects will be randomly assigned to an arm of the study. Enrolled subjects will also be randomly assigned to either right or left side mandibular stent.
Saliva and gingival crevicular fluid and plaque samples will be collected at Day 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. Gingival crevicular fluid (GCF) and plaque samples will not be taken from implants. If one of the posterior teeth is missing, the cuspid tooth will be used as a substitute tooth. Repeat gingival crevicular fluid (GCF) samples will be taken at Day 14, and 21.
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|