Recruiting

Cyanoacrylate Adhesives vs. Sutures

Sponsor:

University of Manitoba

Code:

NCT02935426

Conditions

Wound Closure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

n-butyl cyanoacrylate and 2-octyl cyanoacrylate

5-0 Polytetrafluoroethylene (PTFE) suture

Study Details

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.

Conditions

Wound Closure

Study ID

NCT02935426

Start date

Jan 9, 2017

Status verified date

Oct, 2017

Completion date

Aug, 2018

Anticipated

Primary completion date

Aug, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

32 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cyanoacrylate group

Wound closure after harvesting of connective tissue graft in the donor site will be achieved with application of cyanoacrylate tissue adhesive

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

Interventions

n-butyl cyanoacrylate and 2-octyl cyanoacrylate

used in cyanoacrylate group

5-0 Polytetrafluoroethylene (PTFE) suture

used in suture group

Primary outcome measure

  • Patient's discomfort from the donor site [ Time Frame: During the first week after the surgery ]

Central Contacts and Locations

Central contacts

Chrysi Stavropoulou, DDS

204-960-2447stavropc@myumanitoba.ca

Anastasia Cholakis, DMD, MDent

204-789-3597anastasia.cholakis@umanitoba.ca

Locations

Graduate Periodontics Clinic University of Manitoba

Recruiting

Winnipeg, Manitoba, Canada, R3E 0W2

Contacts

More Information

Sponsor

University of Manitoba

Last update posted

Oct 26, 2017

Last verified

Oct, 2017

Keywords

  • cyanoacrylate
  • sutures

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Manitoba on 2017-10-26.