Properties of Absorbable and Nonabsorbable Suture Material in Dental Surgery

NCT04234308 | Unknown DMC

• 1 other identifier: 010-2019-PRO8
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Suture Adverse Reaction; Suture; Complications, Mechanical; Suture Failure During Surgical Operation; Suture Related Complication; Suture Rupture; Suture; Complications, Infection or Inflammation; Suture Line Infection

Keywords

dental suture; suture infection; Mechanical properties; absorbable sutures; non-absorbable sutures; histological properties

Outcome Measures

Primary Outcomes (3)

• healing changes around each suture material

  To determinate the healing changes around each suture material using the Healing Index of Landry and colleagues (1988)

  1 week, 2 weeks 1 month and 3 months after surgery.

• Tensile and mechanical properties of each suture material

  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).

  following 1 week of clinical application.

• Biofilm formation around each suture material

  To determinate the biofilm formation around each suture material using PCR

  following 1 week of clinical application.

Secondary Outcomes (3)

• complications including erythema, edema, hematoma, infection, wound dehiscence, keloid or scar tissue

  1 week, 2 weeks, 1 month and 3 months after surgery.

• plaque adherence over sutures, number of sutures present and number of stable (untied) sutures

  1 week after surgery.

• subject satisfaction

  1 week and 3 months following surgery.

Study Arms (4)

Polyglycolic Acid Absorbable suture

EXPERIMENTAL

Periodontal and periimplant flaps closed with at least one suture with Polyglycolic Acid Absorbable suture, synthetic, 4-0. (TAGUM®).

Drug: Polyglycolic Acid

Chromic Gut Absorbable suture

EXPERIMENTAL

Periodontal and periimplant flaps closed with at least one suture with Chromic Gut Absorbable suture, natural, 4-0. (TAGUM®)

Drug: Catgut

ePTFE Non absorbable suture

EXPERIMENTAL

Periodontal and periimplant flaps closed with at least one suture with ePTFE Non absorbable suture, synthetic, 4-0. (TAGUM®)

Drug: Polytetrafluoroethylene

Nylon Non absorbable sutures

EXPERIMENTAL

Periodontal and periimplant flaps closed with at least one suture with Nylon Non absorbable sutures, synthetic, 4-0. (TAGUM®)

Drug: Polyamide

Interventions

Polyglycolic Acid DRUG

Periodontal and periimplant flaps closed with at least one suture with Polyglycolic Acid Absorbable suture, synthetic, 4-0. (TAGUM®).

Polyglycolic Acid Absorbable suture

Catgut DRUG

Periodontal and periimplant flaps closed with at least one suture with Chromic Gut Absorbable suture, natural, 4-0. (TAGUM®)

Chromic Gut Absorbable suture

Polytetrafluoroethylene DRUG

Periodontal and periimplant flaps closed with at least one suture with expanded Polytetrafluoroethylene Non absorbable suture, synthetic, 4-0. (TAGUM®)

Also known as: ePTFE

ePTFE Non absorbable suture

Polyamide DRUG

Periodontal and periimplant flaps closed with at least one suture with Nylon Non absorbable sutures, synthetic, 4-0. (TAGUM®)

Also known as: Nylon

Nylon Non absorbable sutures

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must have read, understood and signed the informed consent form. Subject must require either open flap debridement surgery or implant placement (one to three consecutive teeth replacement) surgery.
• Subjects must be males or females who are a minimum of 20 years of age. No history of periodontal or implant surgery at the investigational area site within the past 12 months.
• Periodontal probing depths ≥5 mm interdentally at the implant site. Subjects that received single interrupted sutures for flap closure following surgical procedures.

You may not qualify if:

• Subject is part of a vulnerable population will be excluded. Female subjects who are pregnant or lactating, or who intend to become pregnant during the study period following entrance into the study.
• Subjects with a systemic disease that would preclude periodontal surgery. Subjects who are smokers or chew tobacco. Subjects that received periodontal dressing on the surgical area. Subjects with the presence of acute infectious lesions in the areas intended for surgery.
• Subjects with conditions or circumstances, in the opinion of the Investigator, which would prevent completion of study participation or interfere with analysis of study results.

Sponsors & Collaborators

• Universidad Científica del Sur: lead
• New York University: collaborator

MeSH Terms

Conditions

Infections; Inflammation

Interventions

Polyglycolic Acid; Catgut; Polytetrafluoroethylene; Nylons

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Polyesters; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Sutures; Surgical Fixation Devices; Surgical Equipment; Equipment and Supplies; Fluorocarbon Polymers; Plastics

Study Officials

• Ismael Khouly, PhD

  New York University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carmen Castro Ruiz, DDS

CONTACT

+51952392367; dra.castroruiz@gmail.com

Andrea Vergara, DDS

CONTACT

+51994968218; andreavvb@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2020
• First Posted: January 21, 2020
• Study Start: March 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: March 1, 2021
• Last Updated: January 21, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share