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Properties of Absorbable and Nonabsorbable Suture Material in Dental Surgery

Primary Purpose

Suture Adverse Reaction, Suture; Complications, Mechanical, Suture Failure During Surgical Operation

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Polyglycolic Acid
Catgut
Polytetrafluoroethylene
Polyamide
Sponsored by
Universidad Científica del Sur
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Suture Adverse Reaction focused on measuring dental suture, suture infection, Mechanical properties, absorbable sutures, non-absorbable sutures, histological properties

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Polyglycolic Acid Absorbable suture

    Chromic Gut Absorbable suture

    ePTFE Non absorbable suture

    Nylon Non absorbable sutures

    Arm Description

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

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

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

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

    Outcomes

    Primary Outcome Measures

    healing changes around each suture material
    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
    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
    To determinate the biofilm formation around each suture material using PCR

    Secondary Outcome Measures

    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
    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.
    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.

    Full Information

    First Posted
    January 11, 2020
    Last Updated
    January 15, 2020
    Sponsor
    Universidad Científica del Sur
    Collaborators
    New York University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04234308
    Brief Title
    Properties of Absorbable and Nonabsorbable Suture Material in Dental Surgery
    Official Title
    Clinical, Mechanical, and Histological Properties of Absorbable and Nonabsorbable Suture Materials Used in Periodontal and Dental Implant Surgery.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2020 (Anticipated)
    Primary Completion Date
    December 2020 (Anticipated)
    Study Completion Date
    March 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Universidad Científica del Sur
    Collaborators
    New York University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Suture Adverse Reaction, Suture; Complications, Mechanical, Suture Failure During Surgical Operation, Suture Related Complication, Suture Rupture, Suture; Complications, Infection or Inflammation, Suture Line Infection
    Keywords
    dental suture, suture infection, Mechanical properties, absorbable sutures, non-absorbable sutures, histological properties

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Polyglycolic Acid Absorbable suture
    Arm Type
    Experimental
    Arm Description
    Periodontal and periimplant flaps closed with at least one suture with Polyglycolic Acid Absorbable suture, synthetic, 4-0. (TAGUM®).
    Arm Title
    Chromic Gut Absorbable suture
    Arm Type
    Experimental
    Arm Description
    Periodontal and periimplant flaps closed with at least one suture with Chromic Gut Absorbable suture, natural, 4-0. (TAGUM®)
    Arm Title
    ePTFE Non absorbable suture
    Arm Type
    Experimental
    Arm Description
    Periodontal and periimplant flaps closed with at least one suture with ePTFE Non absorbable suture, synthetic, 4-0. (TAGUM®)
    Arm Title
    Nylon Non absorbable sutures
    Arm Type
    Experimental
    Arm Description
    Periodontal and periimplant flaps closed with at least one suture with Nylon Non absorbable sutures, synthetic, 4-0. (TAGUM®)
    Intervention Type
    Drug
    Intervention Name(s)
    Polyglycolic Acid
    Intervention Description
    Periodontal and periimplant flaps closed with at least one suture with Polyglycolic Acid Absorbable suture, synthetic, 4-0. (TAGUM®).
    Intervention Type
    Drug
    Intervention Name(s)
    Catgut
    Intervention Description
    Periodontal and periimplant flaps closed with at least one suture with Chromic Gut Absorbable suture, natural, 4-0. (TAGUM®)
    Intervention Type
    Drug
    Intervention Name(s)
    Polytetrafluoroethylene
    Other Intervention Name(s)
    ePTFE
    Intervention Description
    Periodontal and periimplant flaps closed with at least one suture with expanded Polytetrafluoroethylene Non absorbable suture, synthetic, 4-0. (TAGUM®)
    Intervention Type
    Drug
    Intervention Name(s)
    Polyamide
    Other Intervention Name(s)
    Nylon
    Intervention Description
    Periodontal and periimplant flaps closed with at least one suture with Nylon Non absorbable sutures, synthetic, 4-0. (TAGUM®)
    Primary Outcome Measure Information:
    Title
    healing changes around each suture material
    Description
    To determinate the healing changes around each suture material using the Healing Index of Landry and colleagues (1988)
    Time Frame
    1 week, 2 weeks 1 month and 3 months after surgery.
    Title
    Tensile and mechanical properties of each suture material
    Description
    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).
    Time Frame
    following 1 week of clinical application.
    Title
    Biofilm formation around each suture material
    Description
    To determinate the biofilm formation around each suture material using PCR
    Time Frame
    following 1 week of clinical application.
    Secondary Outcome Measure Information:
    Title
    complications including erythema, edema, hematoma, infection, wound dehiscence, keloid or scar tissue
    Description
    To determinate the presence of complications including erythema, edema, hematoma, infection, wound dehiscence, keloid or scar tissue
    Time Frame
    1 week, 2 weeks, 1 month and 3 months after surgery.
    Title
    plaque adherence over sutures, number of sutures present and number of stable (untied) sutures
    Description
    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.
    Time Frame
    1 week after surgery.
    Title
    subject satisfaction
    Description
    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.
    Time Frame
    1 week and 3 months following surgery.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Carmen Castro Ruiz, DDS
    Phone
    +51952392367
    Email
    dra.castroruiz@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Andrea Vergara, DDS
    Phone
    +51994968218
    Email
    andreavvb@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ismael Khouly, PhD
    Organizational Affiliation
    New York University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Properties of Absorbable and Nonabsorbable Suture Material in Dental Surgery

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