NCT00946049

Brief Summary

Antibacterial Triclosan-coated suture material (VICRYL PLUS®, Ethicon) and non-coated (VICRYL®) was compared for bacterial colonization after third molar extraction. Sutures were removed postoperatively and adhered bacteria were investigated.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Mar 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 22, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 24, 2009

Completed
Last Updated

July 24, 2009

Status Verified

July 1, 2009

Enrollment Period

2.3 years

First QC Date

July 22, 2009

Last Update Submit

July 23, 2009

Conditions

Bacterial Colonization

Keywords

Checking clinical antibacterial effect of Vicryl Plus compared to conventional Vicryl in intraoral surgeryBacteria

Study Arms (2)

Vicryl Plus

EXPERIMENTAL
Device: Vicryl Plus

Vicryl

ACTIVE COMPARATOR
Device: Vicryl

Interventions

Vicryl PlusDEVICE
Vicryl Plus
VicrylDEVICE
Vicryl

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • planned surgical extraction of 1 to 4 wisdom teeth
  • no inflammation and pain within the planned surgical area
  • legal age
  • clinically healthy patient

You may not qualify if:

  • allergy to Triclosan or phenols
  • gravidity/lactation
  • immunosuppression due to drugs or diseases
  • severe general diseases
  • long-term medication
  • intake or use of other antibiotical drugs/devices

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Albert-Ludwigs-University Freiburg, Department for Oral and Maxillofacial Surgery

Freiburg im Breisgau, 79106, Germany

Location

Study Design

Study Type
interventional
Phase
not applicable
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 22, 2009

First Posted

July 24, 2009

Study Start

March 1, 2005

Primary Completion

June 1, 2007

Study Completion

February 1, 2008

Last Updated

July 24, 2009

Record last verified: 2009-07

Locations

DE(1)