Trials / Completed
CompletedNCT03410433
Suture Materials: an Evaluation
Split-mouth Analysis of Different Suture Materials in Periodontal Surgery: Microbiological and Clinical Aspects
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 36 (actual)
- Sponsor
- Universitaire Ziekenhuizen KU Leuven · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Silk 4.0 | Silk suture 4.0 |
| DEVICE | PG 910 4.0 | PG 910 4.0 |
| DEVICE | PP 4.0 | PP 4.0 |
| DEVICE | Silk 5.0 | Silk 5.0 |
| DEVICE | PG910 5.0 | PG910 5.0 |
| DEVICE | PP 5.0 | PP 5.0 |
| DEVICE | APG 5.0 | APG 5.0 |
| DEVICE | ePTFE 5.0 | ePTFE 5.0 |
Timeline
- Start date
- 2015-02-01
- Primary completion
- 2016-11-01
- Completion
- 2016-11-01
- First posted
- 2018-01-25
- Last updated
- 2018-01-25
Source: ClinicalTrials.gov record NCT03410433. Inclusion in this directory is not an endorsement.