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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03273010
Other study ID # Ordu Uni
Secondary ID
Status Completed
Phase N/A
First received August 3, 2017
Last updated September 1, 2017
Start date December 2015
Est. completion date December 2016

Study information

Verified date September 2017
Source T.C. ORDU ÜNIVERSITESI
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Procedure:
Free gingival graft
Free gingival graft was harvested from palatal donor site
Cyanoacrylate application
Periacyrl was applied on palatal wounds

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
T.C. ORDU ÜNIVERSITESI

Outcome

Type Measure Description Time frame Safety issue
Primary Primary bleeding time The moment of active blood flow stasis that a clinical photograph could be taken by examiner without need for suction. baseline
Secondary Visual Analog Scale (VAS) The changes in postoperative pain level after the operation 1-7 days after operation
Secondary Analgesic consumption The changes in the number of painkiller taken to relieve pain after the operation 1-7 days after operation
Secondary Completion of epithelization The epithelization assessed by the peroxide test Once a week for a month after the operation
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