The Use of Cyanoacrylate on Palatal Wound

September 1, 2017 updated by: Ceren Gökmenoğlu, T.C. ORDU ÜNİVERSİTESİ

The Efficacy of Cyanoacrylate on Palatal Wound Healing and Postoperative Complaints

The palatal donor site of autogenous free gingival grafts significantly influences the patient's morbidity. The purpose of this study was to evaluate the efficacy of cyanoacrylate on palatal wound healing and postoperative complaints.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A total of 35 patients were included in the study. In the test group (19 patient), cyanoacrylate was placed over the palatal wounds; conversely, the 16 control group patients were allowed to heal in a conventional way without cyanoacrylate.

Primary bleeding time, presence of secondary bleeding, postoperative pain and completion of epithelization were assessed following free gingival graft operation. As a result, compared to the control group it was determined that the cyanoacrylate tissue adhesive could reduce the postoperative morbidity and improve the wound healing.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • no systemic diseases
  • no coagulation disorders
  • no drug intake in the previous 6 months that might effect the periodontal health status
  • no pregnancy or lactation
  • no smoking habit
  • <1 mm attached gingiva width on one or two lower anterior teeth
  • Miller Class I- II- III (Miller 1985) with deep gingival recession (˃ 3mm)

Exclusion Criteria:

  • Hematologic disorders
  • No cooperation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Periacryl group
Periacryl, a tissue adhesive, was applied on wound surfaces to achieve haemostasis
Procedure: Free gingival graft
Free gingival graft was harvested from palatal donor site
Procedure: Cyanoacrylate application
Periacyrl was applied on palatal wounds
Active Comparator: Control group
Free gingival graft was harvested from palatal region and left to heal without applying periacryl.
Procedure: Free gingival graft
Free gingival graft was harvested from palatal donor site

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary bleeding time
Time Frame: baseline
The moment of active blood flow stasis that a clinical photograph could be taken by examiner without need for suction.
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale (VAS)
Time Frame: 1-7 days after operation
The changes in postoperative pain level after the operation
1-7 days after operation
Analgesic consumption
Time Frame: 1-7 days after operation
The changes in the number of painkiller taken to relieve pain after the operation
1-7 days after operation
Completion of epithelization
Time Frame: Once a week for a month after the operation
The epithelization assessed by the peroxide test
Once a week for a month after the operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

T.C. ORDU ÜNİVERSİTESİ

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2015

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

August 3, 2017

First Submitted That Met QC Criteria

September 1, 2017

First Posted (Actual)

September 6, 2017

Study Record Updates

Last Update Posted (Actual)

September 6, 2017

Last Update Submitted That Met QC Criteria

September 1, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ordu Uni

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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