NCT04234308

Clinical, Mechanical, and Histological Properties of Absorbable and Nonabsorbable Suture Materials Used in Periodontal and Dental Implant Surgery.

Status unknown NA Last updated 15 January 2020

What this trial tests

NA trial testing Polyglycolic Acid in Suture Adverse Reaction in 200 participants. Status unknown.

Timeline

1 March 2020

Primary endpoint
1 December 2020

1 March 2021

Quick facts

Lead sponsor	Universidad Científica del Sur
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	other
Enrollment	200
Start date	1 March 2020
Primary completion	1 December 2020
Estimated completion	1 March 2021

Drugs / interventions tested

• Polyglycolic Acid — full drug profile →
• Catgut — full drug profile →
• Polytetrafluoroethylene — full drug profile →
• Polyamide — full drug profile →

Conditions studied

• Suture Adverse Reaction — all drugs for Suture Adverse Reaction →
• Suture; Complications, Mechanical — all drugs for Suture; Complications, Mechanical →
• Suture Failure During Surgical Operation — all drugs for Suture Failure During Surgical Operation →
• Suture Related Complication — all drugs for Suture Related Complication →

Sponsor

Universidad Científica del Sur — full company profile →

Who can join

20 and older, any sex, with Suture Adverse Reaction or Suture; Complications, Mechanical. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• healing changes around each suture material
  Time frame: 1 week, 2 weeks 1 month and 3 months after surgery.
  To determinate the healing changes around each suture material using the Healing Index of Landry and colleagues (1988)
• Tensile and mechanical properties of each suture material
  Time frame: following 1 week of clinical application.
  Evaluation of the tensile mechanical properties of each suture material using a Chatilloin TCD200 jig attachment, and tensile load will be applied to each suture at 0.05N/mm per min. Each suture will be stretched to failure and the maximum load will be recorded in Newtons (N).
• Biofilm formation around each suture material
  Time frame: following 1 week of clinical application.
  To determinate the biofilm formation around each suture material using PCR

Sponsor's own description

A suture is a biomedical device that is made of natural or synthetic materials. Sutures are used to close tissue surfaces until wounds heal and regain their ability to withstand normal stresses. Although different suture materials are available for various dental procedures, clinicians commonly neglect to select sutures based on their mechanical properties and capabilities. Instead, clinicians rely on their clinical experience to determine which suture material will suffice for wound closure and healing. To our knowledge, there have been no published studies detailing the results of mechanical testing on sutures after clinical application. The aim of this study is to clinically, histologically, and mechanically assess the four common sutures used in periodontal and dental surgery, with the hopes of providing clinicians with a guide that will allow them to choose sutures based on the clinical, histological, mechanical properties that best fit the stress and strain applied to the wound.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.