Triclosan Toothpaste and Third Molar Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by University of Rochester.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Rochester
ClinicalTrials.gov Identifier:
NCT01292343
First received: February 4, 2011
Last updated: February 7, 2011
Last verified: February 2011
  Purpose

Triclosan containing dentifrices are effective in the prevention of inflammatory complications following third molar surgery through reducing preoperative oral bacteria load.


Condition Intervention
Dry Socket
Wound Infection
Other: Colgate Total Toothpaste
Other: Colgate Regular Toothpaste

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of a Triclosan Containing Dentifrice on Oral Bacteria and Postoperative Complications Following Third Molar Surgery

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • dry socket [ Time Frame: 3 to 7 days ] [ Designated as safety issue: No ]
    Development of dry socket (alveolar osteitis) 3 to 7 days after tooth extraction


Secondary Outcome Measures:
  • wound infection [ Time Frame: 3 to 7 days ] [ Designated as safety issue: No ]
    Development of tooth extraction wound infection 3 to 7 days after extraction


Estimated Enrollment: 120
Study Start Date: February 2008
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Colgate Total Toothpaste
    Toothbrushing with Colgate Total Toothpaste
    Other Names:
    • triclosan
    • dentifrice
    Other: Colgate Regular Toothpaste
    Toothbrushing with Colgate regular toothpaste
    Other Names:
    • fluoride
    • dentifrice
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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01292343

Contacts
Contact: Yanfang Ren, DDS, MPH 585 2735588 yanfang_ren@urmc.rochester.edu

Locations
United States, New York
University of Rochester Eastman Dental Center Recruiting
Rochester, New York, United States, 14620
Contact: Rita Cacciato, RDH    585-275-9001      
Principal Investigator: Yanfang Ren, DDS, MPH         
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Yanfang Ren, DDS, MPH University of Rochester Eastman Dental Center
  More Information

No publications provided

Responsible Party: Yanfang Ren, PI, University of Rochester Eastman Dental Center
ClinicalTrials.gov Identifier: NCT01292343     History of Changes
Other Study ID Numbers: UREDC3rd
Study First Received: February 4, 2011
Last Updated: February 7, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rochester:
third molars
triclosan
toothpaste
dry socket
wound infection

Additional relevant MeSH terms:
Infection
Wound Infection
Postoperative Complications
Dry Socket
Wounds and Injuries
Pathologic Processes
Mouth Diseases
Stomatognathic Diseases
Triclosan
Listerine
Sodium Fluoride
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014