The Use of Cyanoacrylate on Palatal Wound

Not Applicable

Completed

• Conditions: Gingival Recession
• Interventions: Procedure: Free gingival graft; Procedure: Cyanoacrylate application

• Registration Number: NCT03273010
• Lead Sponsor: T.C. ORDU ÜNİVERSİTESİ

Brief Summary

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.

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 Timeline

• Study Start: 2015-12
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Study First Submitted: 2017-08-03
• Status Verified: 2017-09
• Study First Submitted QC: 2017-09-01
• Last Update Submitted: 2017-09-01
• Study First Posted: 2017-09-06
• Last Update Posted: 2017-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Periacryl group	Cyanoacrylate application	Periacryl, a tissue adhesive, was applied on wound surfaces to achieve haemostasis
Periacryl group	Free gingival graft	Periacryl, a tissue adhesive, was applied on wound surfaces to achieve haemostasis
Control group	Free gingival graft	Free gingival graft was harvested from palatal region and left to heal without applying periacryl.

Primary Outcome Measures

Name	Time	Method
Primary bleeding time	baseline	The moment of active blood flow stasis that a clinical photograph could be taken by examiner without need for suction.

Secondary Outcome Measures

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