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Assessment of DAFILON® Suture Material in Oral Surgery (Mucosal Sutures) | Clinical Trials | Clareo Health

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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

NCT04390620•Aesculap AG

View on ClinicalTrials.gov

Summary

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Adult patients undergoing mucosal wound closure using Dafilon as suture material in oral surgery (in the event that more than one incision is performed in the same patient, only one incision will be included).
•Written informed consent regarding the data collection for the PMCF.

Exclusion Criteria

•Emergency surgery.
•Oral surgery procedures requiring bone regeneration.
•Pregnancy.
•Patients taking medication that might affect wound healing.
•Patients with hypersensitivity or allergy to the suture material.

Locations (2)

Praxisklinik für Mund-, Kiefer- und Gesichtschirurgie, Ästhetische und Plastische Chirurgie

Esslingen am Neckar, Germany

Universitat Internacional de Catalunya (UIC)

Barcelona, Spain

Key Dates

Start Date

July 6, 2020

Primary Completion Date

April 7, 2021

Completion Date

April 14, 2021

Last Updated

December 22, 2021

Enrollment

105

ACTUAL participants

Conditions

Oral SurgeryTooth ExtractionDental Implants

Interventions

Mucosal Closure

DEVICE

The Effect of Different Flap Closure Techniques on Postoperative Morbidity in Impacted Third Molar Surgery

NCT07198282

Impacted Mandibular Third MolarPostoperative Morbidity+1 more

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RECRUITING

Clinical and Radiographic Evaluation of Dentsply Sirona PrimeTaper Implants

NCT05500755

Dental Implants

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 22, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

The Effect of Different Flap Closure Techniques on Postoperative Morbidity in Impacted Third Molar Surgery

Clinical and Radiographic Evaluation of Dentsply Sirona PrimeTaper Implants

Clinical Evaluation of a Modified Technique for Free Gingival Graft Stabilization Using Titanium Fixation Tacs Around Implants Versus Conventional Suturing Technique

Combination Therapy Effect of Laser on Wound Healing and Bone Regeneration of Dental Sockets

Comparison of Two Collagen Membranes for Bone Augmentation Around Dental Implants Restored with Monolithic Zirconia Single Crowns

The Application of Root Analogy Implant in Immediate Implantation