Clinical, Mechanical, and Histological Properties of Absorbable and Nonabsorbable Suture Materials Used in Periodontal and Dental Implant Surgery.
Overview
- Phase
- Not Applicable
- Intervention
- Polyglycolic Acid
- Conditions
- Suture Adverse Reaction
- Sponsor
- Universidad Científica del Sur
- Enrollment
- 200
- Primary Endpoint
- healing changes around each suture material
- Last Updated
- 6 years ago
Overview
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.
Investigators
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.
Arms & Interventions
Polyglycolic Acid Absorbable suture
Periodontal and periimplant flaps closed with at least one suture with Polyglycolic Acid Absorbable suture, synthetic, 4-0. (TAGUM®).
Intervention: Polyglycolic Acid
Chromic Gut Absorbable suture
Periodontal and periimplant flaps closed with at least one suture with Chromic Gut Absorbable suture, natural, 4-0. (TAGUM®)
Intervention: Catgut
ePTFE Non absorbable suture
Periodontal and periimplant flaps closed with at least one suture with ePTFE Non absorbable suture, synthetic, 4-0. (TAGUM®)
Intervention: Polytetrafluoroethylene
Nylon Non absorbable sutures
Periodontal and periimplant flaps closed with at least one suture with Nylon Non absorbable sutures, synthetic, 4-0. (TAGUM®)
Intervention: Polyamide
Outcomes
Primary Outcomes
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
Secondary Outcomes
- complications including erythema, edema, hematoma, infection, wound dehiscence, keloid or scar tissue(1 week, 2 weeks, 1 month and 3 months after surgery.)
- subject satisfaction(1 week and 3 months following surgery.)
- plaque adherence over sutures, number of sutures present and number of stable (untied) sutures(1 week after surgery.)