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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04234308
Other study ID # 010-2019-PRO8
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 2020
Est. completion date March 2021

Study information

Verified date January 2020
Source Universidad Científica del Sur
Contact Carmen Castro Ruiz, DDS
Phone +51952392367
Email dra.castroruiz@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 200
Est. completion date March 2021
Est. primary completion date December 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Polyglycolic Acid
Periodontal and periimplant flaps closed with at least one suture with Polyglycolic Acid Absorbable suture, synthetic, 4-0. (TAGUM®).
Catgut
Periodontal and periimplant flaps closed with at least one suture with Chromic Gut Absorbable suture, natural, 4-0. (TAGUM®)
Polytetrafluoroethylene
Periodontal and periimplant flaps closed with at least one suture with expanded Polytetrafluoroethylene Non absorbable suture, synthetic, 4-0. (TAGUM®)
Polyamide
Periodontal and periimplant flaps closed with at least one suture with Nylon Non absorbable sutures, synthetic, 4-0. (TAGUM®)

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Universidad Científica del Sur New York University

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Primary 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.
Primary Biofilm formation around each suture material To determinate the biofilm formation around each suture material using PCR following 1 week of clinical application.
Secondary 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.
Secondary 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.
Secondary 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.
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