Study of the Anti-Inflammatory Effects of Colgate Total® During an Experimental Gingivitis Model
Toothpaste without triclosan
+ Triclosan
Gingival Diseases+3
+ Gingivitis
+ Infections
Summary
Study start date: March 1, 2013
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.32 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 40 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Michigan Center for Oral Health Research
Ann Arbor, United StatesOpen Michigan Center for Oral Health Research in Google Maps