Viewing Study NCT03589235


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Study NCT ID: NCT03589235
Status: COMPLETED
Last Update Posted: 2019-07-18
First Post: 2018-07-02
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Platelet-Rich Fibrin Dressing in the Management of Free Gingival Graft
Sponsor: Damascus University
Organization:

Study Overview

Official Title: Evaluation of the Usage of Platelet-Rich Fibrin Dressing in the Management of Free Gingival Graft and Donor Site Palatal Wound
Status: COMPLETED
Status Verified Date: 2019-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Evaluation of two dressing materials; a Platelet-Rich Fibrin (PRF) dressing and a non-eugenol-based (Coe-Pak™) dressing in the management of free gingival graft and donor site palatal wound.
Detailed Description: Evaluation of the usage of platelet-rich fibrin dressing in the management of free gingival graft and donor site palatal wound by evaluation of pain score, healing tissue in both donor and receiving sites, coverage of gingival recession, and the gain of attached gingiva.

A total of 20 subjects will be invited to participate in this study from the patients seeking treatment at the Department of Periodontology, Faculty of Dentistry, Damascus University.

The study has been approved by the investigator's local Review Board. Subjects will be recruited according to specific inclusion criteria. After completion of medical and dental history questionnaires, patients will sign a consent form after being advised about the nature of the study.

Patients will be allocated into two groups (10 patients each). A Platelet-Rich Fibrin (PRF) dressing will be used in both donor and receiving sites in the test group, while a non-eugenol-based (Coe-Pak™) dressing will be used in both donor and receiving sites in the control group .

Donor site working time, bleeding (BLE), colour match (CM), pain and re-epithelization (EP) will be evaluated.

Study Oversight

Has Oversight DMC: True
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: