Comparison of Cyanoacrylate Adhesives to Sutures in the Palate After Connective Tissue Graft
NCT02935426 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32
Last updated 2017-10-26
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
Interventions
- DEVICE
-
n-butyl cyanoacrylate and 2-octyl cyanoacrylate
used in cyanoacrylate group
- DEVICE
-
5-0 Polytetrafluoroethylene (PTFE) suture
used in suture group
Sponsors & Collaborators
-
University of Manitoba
lead OTHER
Principal Investigators
-
Chrysi Stavropoulou, DDS · University of Manitoba
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2017-01-09
- Primary Completion
- 2018-08-31
- Completion
- 2018-08-31
Countries
- Canada
Study Locations
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