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Comparison of Cyanoacrylate Adhesives to Sutures in the Palate After Connective Tissue Graft

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ClinicalTrials.gov Identifier: NCT02935426
Recruitment Status : Recruiting
First Posted : October 17, 2016
Last Update Posted : October 26, 2017
Sponsor:
Information provided by (Responsible Party):
Chrysi Stavropoulou, University of Manitoba

Brief Summary:
Cyanoacrylate tissue adhesives have been successfully used for wound closure. The purpose of this clinical trial is to compare cyanoacrylate tissue adhesives to polytetrafluoroethylene (PTFE) sutures in the donor site of connective tissue grafts. Two groups of volunteers will randomly assigned to one of the two study groups. The wound closure at the palatal donor area will be achieved with polytetrafluoroethylene (PTFE) sutures in one group and with high viscosity cyanoacrylate tissue adhesives on the other group. The surgical procedure will be performed by one of three calibrated periodontics residents. Data will be collected at baseline-day of the surgery and in one week post-operatively. The primary outcome is patient's discomfort from the donor site during the first week after the surgery. Secondary outcomes is the time required for suture placement or cyanoacrylate application, patient's pain from donor and recipient site one week post-operatively, painkillers intake, presence or absence of inflammation and modified EHI early-wound healing index.

Condition or disease Intervention/treatment Phase
Wound Closure Device: n-butyl cyanoacrylate and 2-octyl cyanoacrylate Device: 5-0 Polytetrafluoroethylene (PTFE) suture Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Cyanoacrylate Tissue Adhesives to Polytetrafluoroethylene (PTFE) Sutures in the Donor Site of Connective Tissue Grafts- A Randomized Clinical Trial
Actual Study Start Date : January 9, 2017
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Arm Intervention/treatment
Experimental: Cyanoacrylate group
Wound closure after harvesting of connective tissue graft in the donor site will be achieved with application of cyanoacrylate tissue adhesive
Device: n-butyl cyanoacrylate and 2-octyl cyanoacrylate
used in cyanoacrylate group
Other Name: PeriAcryl®90

Active Comparator: Suture group
Wound closure after harvesting of connective tissue graft in the donor site will be achieved with polytetrafluoroethylene (PTFE) continuous interlocking sutures
Device: 5-0 Polytetrafluoroethylene (PTFE) suture
used in suture group




Primary Outcome Measures :
  1. Patient's discomfort from the donor site [ Time Frame: During the first week after the surgery ]
    VAS questionnaire


Secondary Outcome Measures :
  1. Operative time [ Time Frame: A baseline-during the surgery ]
    Time required to place sutures or to apply cyanoacrylate tissue adhesives

  2. Pain from the donor site [ Time Frame: one day after the surgery ]
    VAS questionnaire

  3. Pain from donor site [ Time Frame: During the first week after the surgery ]
    VAS questionnaire

  4. Painkillers intake [ Time Frame: during the first week after the surgery ]
    amount of Ibuprofen consumed during the first week after the surgery

  5. modified EHI early-wound healing index [ Time Frame: one week post-operatively ]
    assessment of wound closure and presence of fibrin and/or necrosis

  6. Complications [ Time Frame: one week post-operatively ]
    severe bleeding (more than 20 min), infection (swollen and presence of pus), abnormal pain (maximum consumption of painkillers, self-medication), root exposure, sloughing, other



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients of the Graduate Periodontics Clinic, College of Dentistry, University of Manitoba that require harvesting of subepithelial connective tissue graft from the palate from October 2016 to December 2017 and have signed the consent form.

Exclusion Criteria:

  • Patients with coagulation disorders (Hemophilia a/b, von Willebrand disease, liver disease, anticoagulative therapy), patients on corticosteroids, patients with uncontrolled diabetes mellitus or with any systematic disease that periodontal surgery is contraindicated, and patient with history of contact dermatitis to formaldehyde will be excluded from the trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02935426


Contacts
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Contact: Chrysi Stavropoulou, DDS 204-960-2447 stavropc@myumanitoba.ca
Contact: Anastasia Cholakis, DMD, MDent 204-789-3597 anastasia.cholakis@umanitoba.ca

Locations
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Canada, Manitoba
Graduate Periodontics Clinic University of Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3E 0W2
Contact: Chrysi Stavropoulou    204-960-2447    stavropc@myumanitoba.ca   
Contact: Anastasia Cholakis    204-975-7765    Anastasia.Cholakis@umanitoba.ca   
Sponsors and Collaborators
University of Manitoba
Investigators
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Principal Investigator: Chrysi Stavropoulou, DDS University of Manitoba

Publications of Results:

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Responsible Party: Chrysi Stavropoulou, Periodontics Resident, University of Manitoba
ClinicalTrials.gov Identifier: NCT02935426     History of Changes
Other Study ID Numbers: B2016:092
First Posted: October 17, 2016    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Chrysi Stavropoulou, University of Manitoba:
cyanoacrylate
sutures