Suture Materials: an Evaluation

Study Overview
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Brief Summary
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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.

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

Conditions
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Suture Materials

Intervention / Treatment
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* Device: Silk 4.0
* Device: PG 910 4.0
* Device: PP 4.0
* Device: Silk 5.0
* Device: PG910 5.0
* Device: PP 5.0
* Device: APG 5.0
* Device: ePTFE 5.0


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Silk 4.0<br>Silk suture | Device: Silk 4.0<br>* Silk suture 4.0<br>|
| Active Comparator: PG910 4.0<br>Vicryl Rapid suture | Device: PG 910 4.0<br>* PG 910 4.0<br>|
| Experimental: PP 4.0<br>Non-absorbable polypropylene monofilament | Device: PP 4.0<br>* PP 4.0<br>|
| Active Comparator: Silk 5.0<br>Silk suture | Device: Silk 5.0<br>* Silk 5.0<br>|
| Active Comparator: PG910 5.0<br>Vicryl suture | Device: PG910 5.0<br>* PG910 5.0<br>|
| Experimental: PP 5.0<br>Non-absorbable polypropylene monofilament | Device: PP 5.0<br>* PP 5.0<br>|
| Experimental: APG 5.0<br>Antibacterial Vicryl suture | Device: APG 5.0<br>* APG 5.0<br>|
| Experimental: ePTFE 5.0<br>expanded polytetrafluoroethylene | Device: ePTFE 5.0<br>* ePTFE 5.0<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area of inflammation | 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). | 7 to 14 days | 
| Microbial deposits on the sutures | The composition of the microbial deposits on the suture materials was examined with qPCR. | 7 to 14 days |