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Cyanoacrylate With Sutures for Fixation of Free Gingival Graft

Primary Purpose

Soft Tissue Atrophy

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
cyanoacrylate tissue adhesive beside sutures
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Soft Tissue Atrophy

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients with hopeless teeth that need extraction
  • Age: between 20 and 60 years
  • Both sexes.
  • Subjects willing to sign an informed consent form ,participate in the study and return for follow-up visits

Exclusion Criteria:

  • • Patients with coagulation disorders (Hemophilia a/b, von Willebrand disease, liver disease, anticoagulative therapy),

    • patients on corticosteroids,
    • patients with uncontrolled diabetes mellitus
    • smokers
    • Pregnant or lactating mother.
    • Known systemic diseases and/ or drug therapy which may interfere with wound healing or contraindicate periodontal therapy
    • Allergy to cyanoacrylate

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    cyanoacrylate beside sutures for FGG fixation

    Arm Description

    butyl cyanoacrylate

    Outcomes

    Primary Outcome Measures

    graft shrinkage in millimeter
    graft area ,thickness in millimeter

    Secondary Outcome Measures

    success percentage
    % percentage (success of Free Gingival Graft Fixation)

    Full Information

    First Posted
    June 16, 2019
    Last Updated
    August 20, 2019
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04063475
    Brief Title
    Cyanoacrylate With Sutures for Fixation of Free Gingival Graft
    Official Title
    Cyanoacrylate Tissue Adhesive Assisted Soft Tissue Stabilization: a Novel Technique for Free Gingival Graft Fixation (Case Series Study)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 16, 2019 (Anticipated)
    Primary Completion Date
    June 2020 (Anticipated)
    Study Completion Date
    June 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo 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

    5. Study Description

    Brief Summary
    fixation of FGG with sutures alone is not sufficient,we use cyanoacrylate beside sutures for fixation
    Detailed Description
    Inadequate zone of attached mucosa around implants, gingival recession, inadequate ridge width or height despite there is enouph bone for implant placement are problems that face periodontists and can be treated by soft tissue graft Studies have demonstrated the importance of the tissues stability for the first hours when support is provided by underlying osseous or dental structures. Movement of the graft during mastication and phonation will disturb healing procedures. Most of the clinicians prefer a protective device during the healing phase. Transitional dentures are not stable themselves, and hence are not suitable for stabilizing. Circummandibular wiring and impact posts are seemingly very aggressive for patients and need extra clinical practices, skills, and equipment. Studies proved that the maximum tissue shrinkage (approximately 20%-40%) occurs during the first 3 months post operation and will proceed until 12 postsurgical months with a persistent, significantly lower rate. In this study we give more stabilization for free gingival grafts by using cyanoacrylate tissue adhesive beside sutures Its autogenous character, maintenance of keratinization, predictability, ease of technique tlead CTG to be accepted as the golden standard to increase attached gingival dimensions Cyanoacrylate is a simple, inexpensive haemostatic and biocompatible material It is used as tissue adhesives in paediatric surgery general surgery and also dentistry. it has been applied intraorally with different purposes such as periodontal dressing,for sealing sinus membrane perforations for stabilizing bone fragments during fracture fixation, and in closing peripheral nerve anastomosis it seems promising in the intraoral field due to their strong sealing, bacteriostatic, and hemostatic properties. Multiple studies examined the use of cyanoacrylate glues as an alternative to suturing intraoral and extraoral wounds concluding that cyanoacrylates are faster, more reliable ,and less painful and cause better hemostasis .

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Soft Tissue Atrophy

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Cyanoacrylate beside sutures for Fixation of FGG
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    10 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    cyanoacrylate beside sutures for FGG fixation
    Arm Type
    Experimental
    Arm Description
    butyl cyanoacrylate
    Intervention Type
    Drug
    Intervention Name(s)
    cyanoacrylate tissue adhesive beside sutures
    Other Intervention Name(s)
    tissue adhesive
    Intervention Description
    using cyanoacrylate tissue adhesive for FGG fixation
    Primary Outcome Measure Information:
    Title
    graft shrinkage in millimeter
    Description
    graft area ,thickness in millimeter
    Time Frame
    2 weeks,month,3months
    Secondary Outcome Measure Information:
    Title
    success percentage
    Description
    % percentage (success of Free Gingival Graft Fixation)
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients with hopeless teeth that need extraction Age: between 20 and 60 years Both sexes. Subjects willing to sign an informed consent form ,participate in the study and return for follow-up visits Exclusion Criteria: • Patients with coagulation disorders (Hemophilia a/b, von Willebrand disease, liver disease, anticoagulative therapy), patients on corticosteroids, patients with uncontrolled diabetes mellitus smokers Pregnant or lactating mother. Known systemic diseases and/ or drug therapy which may interfere with wound healing or contraindicate periodontal therapy Allergy to cyanoacrylate

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Cyanoacrylate With Sutures for Fixation of Free Gingival Graft

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