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Clinical Trials/NCT03410433
NCT03410433
Completed
Not Applicable

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

Universitaire Ziekenhuizen KU Leuven0 sites36 target enrollmentFebruary 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Suture Materials
Sponsor
Universitaire Ziekenhuizen KU Leuven
Enrollment
36
Primary Endpoint
Accumulation of soft deposits
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
February 2015
End Date
November 2016
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Area of inflammation(7 to 14 days)
  • Microbial deposits on the sutures(7 to 14 days)

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