Suture Materials: an Evaluation
Split-mouth Analysis of Different Suture Materials in Periodontal Surgery: Microbiological and Clinical Aspects
1 other identifier
interventional
36
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2015
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedFirst Submitted
Initial submission to the registry
January 18, 2018
CompletedFirst Posted
Study publicly available on registry
January 25, 2018
CompletedJanuary 25, 2018
January 1, 2018
1.8 years
January 18, 2018
January 24, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Accumulation of soft deposits
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 Outcomes (2)
Area of inflammation
7 to 14 days
Microbial deposits on the sutures
7 to 14 days
Study Arms (8)
Silk 4.0
ACTIVE COMPARATORSilk suture
PG910 4.0
ACTIVE COMPARATORVicryl Rapid suture
PP 4.0
EXPERIMENTALNon-absorbable polypropylene monofilament
Silk 5.0
ACTIVE COMPARATORSilk suture
PG910 5.0
ACTIVE COMPARATORVicryl suture
PP 5.0
EXPERIMENTALNon-absorbable polypropylene monofilament
APG 5.0
EXPERIMENTALAntibacterial Vicryl suture
ePTFE 5.0
EXPERIMENTALexpanded polytetrafluoroethylene
Interventions
Eligibility Criteria
You may qualify if:
- patients
- in need for periodontal surgery
- patients in good general health
- able to sign IC form
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Officials
- STUDY DIRECTOR
Marc Quirynen
KU Leuven
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 18, 2018
First Posted
January 25, 2018
Study Start
February 1, 2015
Primary Completion
November 1, 2016
Study Completion
November 1, 2016
Last Updated
January 25, 2018
Record last verified: 2018-01
Data Sharing
- IPD Sharing
- Will not share