Triclosan Toothpaste and Third Molar Surgery

Wound Infection Clinical Trial

Official title:

Effect of a Triclosan Containing Dentifrice on Oral Bacteria and Postoperative Complications Following Third Molar Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01292343
• Other study ID #: UREDC3rd
• Status: Completed
• Phase: N/A
• First received: February 4, 2011
• Last updated: October 26, 2015
• Start date: February 2008
• Est. completion date: February 2013

Study information

• Verified date: October 2015
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dry Socket
• Postoperative Complications
• Wound Infection

Intervention

Other:
• Colgate Total Toothpaste
Toothbrushing with Colgate Total Toothpaste
• Colgate Regular Toothpaste
Toothbrushing with Colgate regular toothpaste

Locations

Country	Name	City	State
United States	University of Rochester Eastman Dental Center	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	dry socket	Development of dry socket (alveolar osteitis) 3 to 7 days after tooth extraction	3 to 7 days	No
Secondary	wound infection	Development of tooth extraction wound infection 3 to 7 days after extraction	3 to 7 days	No