NCT04390620

Assessment of DAFILON® Suture Material in Oral Surgery (Mucosal Sutures)

Assessment of DAFILON® Suture Material in Oral Surgery (Mucosal Sutures). A Prospective, Single Arm Observational Study in Daily Practice

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 105 (actual)
• Sponsor: Aesculap AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this non-interventional study (NIS) a polyamide non-absorbable suture (Dafilon) will be evaluated for oral surgery (mucosal closure after e.g. wisdom teeth extraction, implant surgery, etc.) in adult patients

Detailed description

In this non-interventional study (NIS) a polyamide non-absorbable suture (Dafilon) will be evaluated for oral surgery (mucosal closure after e.g. wisdom teeth extraction, implant surgery, etc.) in adult patients. The aim of this NIS is to collect systematically and proactively different clinical parameters regarding safety, effectiveness and performance of Dafilon suture material under the daily routine clinical practice when is intended to be used for oral surgery. All patients enrolled will be prospectively followed until suture removal, which takes place 10 ± 5 days post-operatively (and post-operatively depending on routine clinical practice of each hospital).

Conditions

• Oral Surgery
• Tooth Extraction
• Dental Implants

Interventions

Type	Name	Description
DEVICE	Mucosal Closure	mucosal closure in oral surgery (mucosal sutures)

Timeline

• Start date: 2020-07-06
• Primary completion: 2021-04-07
• Completion: 2021-04-14
• First posted: 2020-05-15
• Last updated: 2021-12-22

Locations

2 sites across 2 countries: Germany, Spain