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OpenTrials
Completed

NCT Number: NCT03410433

Suture Materials: an Evaluation

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.

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Key information

Conditions

Suture Materials

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Silk 4.0

Device

Silk suture 4.0

PG 910 4.0

Device

PG 910 4.0

PP 4.0

Device

PP 4.0

Silk 5.0

Device

Silk 5.0

PG910 5.0

Device

PG910 5.0

PP 5.0

Device

PP 5.0

APG 5.0

Device

APG 5.0

ePTFE 5.0

Device

ePTFE 5.0

Primary outcomes

  1. 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

  1. 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).

  2. 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.

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 25, 2018
Registry last updated
Jan 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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