- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01292343
Triclosan Toothpaste and Third Molar Surgery
October 26, 2015 updated by: Yanfang Ren, University of Rochester
Effect of a Triclosan Containing Dentifrice on Oral Bacteria and Postoperative Complications Following Third Molar Surgery
Triclosan containing dentifrices are effective in the prevention of inflammatory complications following third molar surgery through reducing preoperative oral bacteria load.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study may provide evidence on the effect of triclosan containing dentifrice on oral bacteria and oral inflammation prior to third molar surgery, and on the incidence of inflammatory complications after the surgery.
If proven effective, dentifrice containing triclosan may be recommended prior to tooth extractions and replace antibiotics and other antimicrobial products as a prophylactic procedure before oral surgery procedures.
Study Type
Interventional
Enrollment (Actual)
141
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Rochester, New York, United States, 14620
- University of Rochester Eastman Dental Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 33 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- must include at least one mandibular third molar with partial or full bony impaction
- no sign of active pericoronal (around the crown) infections
- must have not taken antibiotics for any reason in the past 30 days
- must be healthy and between 18 and 35 years of age
- must be able to read and sign an informed consent
Exclusion Criteria:
- Subjects with systemic diseases and pregnant or lactating women
- Subjects with advanced periodontal diseases or having two or more untreated caries lesions
- Subjects who cannot read and sign an informed consent
- Subjects with signs of pericoronal infections
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
dry socket
Time Frame: 3 to 7 days
|
Development of dry socket (alveolar osteitis) 3 to 7 days after tooth extraction
|
3 to 7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
wound infection
Time Frame: 3 to 7 days
|
Development of tooth extraction wound infection 3 to 7 days after extraction
|
3 to 7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Yanfang Ren, DDS, MPH, University of Rochester Eastman Dental Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2008
Primary Completion (Actual)
February 1, 2013
Study Completion (Actual)
February 1, 2013
Study Registration Dates
First Submitted
February 4, 2011
First Submitted That Met QC Criteria
February 7, 2011
First Posted (Estimate)
February 9, 2011
Study Record Updates
Last Update Posted (Estimate)
October 28, 2015
Last Update Submitted That Met QC Criteria
October 26, 2015
Last Verified
October 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Stomatognathic Diseases
- Mouth Diseases
- Wound Infection
- Dry Socket
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents, Local
- Anti-Infective Agents
- Antimetabolites
- Protective Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Cariostatic Agents
- Fatty Acid Synthesis Inhibitors
- Listerine
- Fluorides
- Sodium Fluoride
- Triclosan
Other Study ID Numbers
- UREDC3rd
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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