Properties of Absorbable and Nonabsorbable Suture Material in Dental Surgery

Study 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.

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

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

Intervention / Treatment
-----------------
* Drug: Polyglycolic Acid
* Drug: Catgut
* Drug: Polytetrafluoroethylene
* Drug: Polyamide


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Polyglycolic Acid Absorbable suture<br>Periodontal and periimplant flaps closed with at least one suture with Polyglycolic Acid Absorbable suture, synthetic, 4-0. (TAGUM®). | Drug: Polyglycolic Acid<br>* Periodontal and periimplant flaps closed with at least one suture with Polyglycolic Acid Absorbable suture, synthetic, 4-0. (TAGUM®).<br>|
| Experimental: Chromic Gut Absorbable suture<br>Periodontal and periimplant flaps closed with at least one suture with Chromic Gut Absorbable suture, natural, 4-0. (TAGUM®) | Drug: Catgut<br>* Periodontal and periimplant flaps closed with at least one suture with Chromic Gut Absorbable suture, natural, 4-0. (TAGUM®)<br>|
| Experimental: ePTFE Non absorbable suture<br>Periodontal and periimplant flaps closed with at least one suture with ePTFE Non absorbable suture, synthetic, 4-0. (TAGUM®) | Drug: Polytetrafluoroethylene<br>* Periodontal and periimplant flaps closed with at least one suture with expanded Polytetrafluoroethylene Non absorbable suture, synthetic, 4-0. (TAGUM®)<br>* Other names: ePTFE;|
| Experimental: Nylon Non absorbable sutures<br>Periodontal and periimplant flaps closed with at least one suture with Nylon Non absorbable sutures, synthetic, 4-0. (TAGUM®) | Drug: Polyamide<br>* Periodontal and periimplant flaps closed with at least one suture with Nylon Non absorbable sutures, synthetic, 4-0. (TAGUM®)<br>* Other names: Nylon;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complications including erythema, edema, hematoma, infection, wound dehiscence, keloid or scar tissue | To determinate the presence of 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 | To determinate the plaque adherence over sutures, number of sutures present and number of stable (untied) sutures • Plaque adherence over sutures. This will be classified as following: 0: no debris or plaque present; soft debris or plaque covering not more than one third of the sutures, soft debris or plaque covering more than one third of the exposed suture; soft debris of plaque covering more than two thirds of the exposed sutures. | 1 week after surgery. | 
| subject satisfaction | To determinate subject pain/satisfaction using a Visual Analogue Scale (VAS) at Visits 2 and 5. The VAS will be given to the subject in order to rate the satisfaction on a scale from 0 to 10, where 10 is the highest level of pain/satisfaction. | 1 week and 3 months following surgery. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dental suture, suture infection, Mechanical properties, absorbable sutures, non-absorbable sutures, histological properties