Split-mouth Analysis of Different Suture Materials in Periodontal Surgery: Microbiological and Clinical Aspects
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 36
- Primary Endpoint
- Accumulation of soft deposits
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Silk 4.0
Silk suture
Intervention: Silk 4.0 (Device)
PG910 4.0
Vicryl Rapid suture
Intervention: PG 910 4.0 (Device)
PP 4.0
Non-absorbable polypropylene monofilament
Intervention: PP 4.0 (Device)
Silk 5.0
Silk suture
Intervention: Silk 5.0 (Device)
PG910 5.0
Vicryl suture
Intervention: PG910 5.0 (Device)
PP 5.0
Non-absorbable polypropylene monofilament
Intervention: PP 5.0 (Device)
APG 5.0
Antibacterial Vicryl suture
Intervention: APG 5.0 (Device)
ePTFE 5.0
expanded polytetrafluoroethylene
Intervention: ePTFE 5.0 (Device)
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)