Bacterial ColonizationNCT00946049
Oral Bacteria on Suture Materials - Clinical Comparison of an Antibacterial-coated and a Non-coated Suture Material
A study testing Vicryl Plus and Vicryl in people with Bacterial Colonization, run by University Hospital Freiburg at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Bacterial Colonization
- What is being tested?
- Vicryl Plus and Vicryl
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteGermany
- Study dates
- Mar 2005to Feb 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- planned surgical extraction of 1 to 4 wisdom teeth
- no inflammation and pain within the planned surgical area
- legal age
- clinically healthy patient
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Albert-Ludwigs-University Freiburg, Department for Oral and Maxillofacial Surgery
Freiburg im Breisgau, 79106
About this study
Official title: Oral Bacteria on Suture Materials - Clinical Comparison of an Antibacterial-coated and a Non-coated Suture Material (VICRYL PLUS® vs. VICRYL®, Ethicon) in Intraoral Dentoalveolar Surgery
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.
- Conditions
- Bacterial Colonization
- Being tested
- Vicryl Plus, Vicryl
- Keywords
- Checking clinical antibacterial effect of Vicryl Plus compared to conventional Vicryl in intraoral surgery, Bacteria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vicryl PlusDevice
VicrylDevice
| Study group | Role | What they receive |
|---|---|---|
| Vicryl Plus | Experimental | Not described Receives: Device: Vicryl Plus |
| Vicryl | Active comparator | Not described Receives: Device: Vicryl |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2009 (estimated)
- Study startMar 2005
- Primary completionJun 2007
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial ColonizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- University Hospital Freiburg
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00946049
- Sponsor's protocol ID
- 323/05
- Status last verified
- Jul 2009
- First submitted
- 22 Jul 2009
- Last updated
- 24 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Bacteria on Suture Materials - Clinical Comparison of an Antibacterial-coated and a Non-coated Suture Material (VICRYL PLUS® vs. VICRYL®, Ethicon) in Intraoral Dentoalveolar Surgery
- ClinicalTrials.gov ID
- NCT00946049
- Acronym / sponsor ID
- 323/05
- Conditions
- Bacterial Colonization
- Keywords
- Checking clinical antibacterial effect of Vicryl Plus compared to conventional Vicryl in intraoral surgery, Bacteria
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University Hospital FreiburgUniversity, hospital or other
- Study start
- Mar 2005
- Primary completion
- Jun 2007 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 24 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vicryl Plus | Experimental | Device: Vicryl Plus |
| Vicryl | Active comparator | Device: Vicryl |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- planned surgical extraction of 1 to 4 wisdom teeth
- no inflammation and pain within the planned surgical area
- legal age
- clinically healthy patient
Key exclusion criteria (6 listed)
- allergy to Triclosan or phenols
- gravidity/lactation
- immunosuppression due to drugs or diseases
- severe general diseases
- long-term medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vicryl Plus | Device | Vicryl Plus |
| Vicryl | Device | Vicryl |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vicryl Plus and Vicryl in people with Bacterial Colonization, run by University Hospital Freiburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2009.