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

NCT02935426 | Unknown DMC

• 1 other identifier: B2016:092
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Keywords

cyanoacrylate; sutures

Outcome Measures

Primary Outcomes (1)

• Patient's discomfort from the donor site

  VAS questionnaire

  During the first week after the surgery

Secondary Outcomes (6)

• Operative time

  A baseline-during the surgery

• Pain from the donor site

  one day after the surgery

• Pain from donor site

  During the first week after the surgery

• Painkillers intake

  during the first week after the surgery

• modified EHI early-wound healing index

  one week post-operatively

Study Arms (2)

Cyanoacrylate group

EXPERIMENTAL

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

Suture group

ACTIVE COMPARATOR

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

Interventions

n-butyl cyanoacrylate and 2-octyl cyanoacrylate DEVICE

used in cyanoacrylate group

Also known as: PeriAcryl®90

Cyanoacrylate group

5-0 Polytetrafluoroethylene (PTFE) suture DEVICE

used in suture group

Suture group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

Graduate Periodontics Clinic University of Manitoba

Winnipeg, Manitoba, R3E 0W2, Canada

RECRUITING

Related Publications (26)

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MeSH Terms

Interventions

Sutures

Intervention Hierarchy (Ancestors)

Surgical Fixation Devices; Surgical Equipment; Equipment and Supplies

Study Officials

• Chrysi Stavropoulou, DDS

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chrysi Stavropoulou, DDS

CONTACT

204-960-2447; stavropc@myumanitoba.ca

Anastasia Cholakis, DMD, MDent

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Periodontics Resident

Study Record Dates

• First Submitted: October 13, 2016
• First Posted: October 17, 2016
• Study Start: January 9, 2017
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: October 26, 2017

Record last verified: 2017-10

Locations

CA (1)