Suture Materials: an Evaluation

January 24, 2018 updated by: Universitaire Ziekenhuizen KU Leuven

Split-mouth Analysis of Different Suture Materials in Periodontal Surgery: Microbiological and Clinical Aspects

Background: Many factors play a role when selecting an appropriate suture for optimal soft tissue healing in oral surgery. Moreover, the oral cavity has its specific challenges: it is an aqueous environment in which biofilm formation takes place on all surfaces. Therefore, oral surgery has specific demands for suture materials.

Aim: The primary objective of this study was to compare the bacterial load on different suture materials. The secondary objective was to determine the impact of suture material on decubitus.

Material & methods: This prospective experimental study with a 'split-mouth' design enrolled 36 patients requiring oral surgery. Five different suture materials were compared regarding their microbiological load and decubitus at the suture removal. Bacterial accumulation on the same 5 suture materials was also tested in an in vitro biofilm model.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 36 patients
  • in need for periodontal surgery
  • patients in good general health
  • able to sign IC form

Exclusion Criteria:

  • patients that were deemed unlikely to comply with the study protocol, as judged by the examiner
  • patients who had a present alcohol and/or drug abuse

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Silk 4.0
Silk suture
Device: Silk 4.0
Silk suture 4.0
ACTIVE_COMPARATOR: PG910 4.0
Vicryl Rapid suture
Device: PG 910 4.0
PG 910 4.0
EXPERIMENTAL: PP 4.0
Non-absorbable polypropylene monofilament
Device: PP 4.0
PP 4.0
ACTIVE_COMPARATOR: Silk 5.0
Silk suture
Device: Silk 5.0
Silk 5.0
ACTIVE_COMPARATOR: PG910 5.0
Vicryl suture
Device: PG910 5.0
PG910 5.0
EXPERIMENTAL: PP 5.0
Non-absorbable polypropylene monofilament
Device: PP 5.0
PP 5.0
EXPERIMENTAL: APG 5.0
Antibacterial Vicryl suture
Device: APG 5.0
APG 5.0
EXPERIMENTAL: ePTFE 5.0
expanded polytetrafluoroethylene
Device: ePTFE 5.0
ePTFE 5.0

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accumulation of soft deposits
Time Frame: 7 to 14 days
Accumulation of soft deposits on each suture material was assessed visually as being present or absent before removing the knots.
7 to 14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area of inflammation
Time Frame: 7 to 14 days
Clinical photographs were taken, calibrated with a ruler of 0.5 mm accuracy as is illustrated in Figure 2, before and after suture removal in both parts of the clinical study. Subsequently, the area of inflammation surrounding the sutures was measured by two separate examiners using the image-analysis program, Image J® (NIH, Bethesda, Maryland, USA).
7 to 14 days
Microbial deposits on the sutures
Time Frame: 7 to 14 days
The composition of the microbial deposits on the suture materials was examined with qPCR.
7 to 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Investigators

  • Study Director: Marc Quirynen, KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2015

Primary Completion (ACTUAL)

November 1, 2016

Study Completion (ACTUAL)

November 1, 2016

Study Registration Dates

First Submitted

January 18, 2018

First Submitted That Met QC Criteria

January 24, 2018

First Posted (ACTUAL)

January 25, 2018

Study Record Updates

Last Update Posted (ACTUAL)

January 25, 2018

Last Update Submitted That Met QC Criteria

January 24, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • S58697

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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