Viewing Study NCT03410433


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Study NCT ID: NCT03410433
Status: COMPLETED
Last Update Posted: 2018-01-25
First Post: 2018-01-18
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Suture Materials: an Evaluation
Sponsor: Universitaire Ziekenhuizen KU Leuven
Organization:

Study Overview

Official Title: Split-mouth Analysis of Different Suture Materials in Periodontal Surgery: Microbiological and Clinical Aspects
Status: COMPLETED
Status Verified Date: 2018-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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.
Detailed Description: None

Study Oversight

Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: