search
Back to results

Triclosan Toothpaste and Third Molar Surgery

Primary Purpose

Dry Socket, Wound Infection

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Colgate Total Toothpaste
Colgate Regular Toothpaste
Sponsored by
University of Rochester
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dry Socket focused on measuring third molars, triclosan, toothpaste, dry socket, wound infection

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Rochester Eastman Dental Center

Outcomes

Primary Outcome Measures

dry socket
Development of dry socket (alveolar osteitis) 3 to 7 days after tooth extraction

Secondary Outcome Measures

wound infection
Development of tooth extraction wound infection 3 to 7 days after extraction

Full Information

First Posted
February 4, 2011
Last Updated
October 26, 2015
Sponsor
University of Rochester
search

1. Study Identification

Unique Protocol Identification Number
NCT01292343
Brief Title
Triclosan Toothpaste and Third Molar Surgery
Official Title
Effect of a Triclosan Containing Dentifrice on Oral Bacteria and Postoperative Complications Following Third Molar Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Socket, Wound Infection
Keywords
third molars, triclosan, toothpaste, dry socket, wound infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
141 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
Colgate Total Toothpaste
Other Intervention Name(s)
triclosan, dentifrice
Intervention Description
Toothbrushing with Colgate Total Toothpaste
Intervention Type
Other
Intervention Name(s)
Colgate Regular Toothpaste
Other Intervention Name(s)
fluoride, dentifrice
Intervention Description
Toothbrushing with Colgate regular toothpaste
Primary Outcome Measure Information:
Title
dry socket
Description
Development of dry socket (alveolar osteitis) 3 to 7 days after tooth extraction
Time Frame
3 to 7 days
Secondary Outcome Measure Information:
Title
wound infection
Description
Development of tooth extraction wound infection 3 to 7 days after extraction
Time Frame
3 to 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yanfang Ren, DDS, MPH
Organizational Affiliation
University of Rochester Eastman Dental Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester Eastman Dental Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Triclosan Toothpaste and Third Molar Surgery

We'll reach out to this number within 24 hrs