Properties of Absorbable and Nonabsorbable Suture Material in Dental Surgery

Universidad Científica del Sur

Status: Unknown

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

Treatments: Drug: Polyglycolic Acid; Drug: Polytetrafluoroethylene; Drug: Catgut; Drug: Polyamide

Study type: Interventional

Funder types: Other

Identifiers

NCT04234308

010-2019-PRO8

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 4 patient groups

Polyglycolic Acid Absorbable suture

Experimental group

Description:

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

Treatment:

Drug: Polyglycolic Acid

Chromic Gut Absorbable suture

Experimental group

Description:

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

Treatment:

Drug: Catgut

ePTFE Non absorbable suture

Experimental group

Description:

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

Treatment:

Drug: Polytetrafluoroethylene

Nylon Non absorbable sutures

Experimental group

Description:

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

Treatment:

Drug: Polyamide