Properties of Absorbable and Nonabsorbable Suture Material in Dental Surgery

NCT ID: NCT04234308

Last Updated: 2020-01-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-31
• Study Completion Date: 2021-03-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Polyglycolic Acid Absorbable suture

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

Group Type: EXPERIMENTAL

Polyglycolic Acid

Intervention Type: DRUG

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

Chromic Gut Absorbable suture

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

Group Type: EXPERIMENTAL

Catgut

Intervention Type: DRUG

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

ePTFE Non absorbable suture

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

Group Type: EXPERIMENTAL

Polytetrafluoroethylene

Intervention Type: DRUG

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

Nylon Non absorbable sutures

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

Group Type: EXPERIMENTAL

Polyamide

Intervention Type: DRUG

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

Interventions

Polyglycolic Acid

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

Intervention Type: DRUG

Catgut

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

Intervention Type: DRUG

Polytetrafluoroethylene

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

Intervention Type: DRUG

Polyamide

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

Intervention Type: DRUG

Other Intervention Names

ePTFE; Nylon

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

New York University

OTHER

Sponsor Role: collaborator

Universidad Científica del Sur

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ismael Khouly, PhD

Role: PRINCIPAL_INVESTIGATOR

New York University

Central Contacts

Carmen Castro Ruiz, DDS

Role: CONTACT

dra.castroruiz@gmail.com

+51952392367

Andrea Vergara, DDS

Role: CONTACT

andreavvb@gmail.com

+51994968218

Other Identifiers

010-2019-PRO8

Identifier Type: -

Identifier Source: org_study_id