Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Adjunctive Role of PRF After Free Gingival Graft Harvesting - Case Series

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02521467
Recruitment Status : Completed
First Posted : August 13, 2015
Last Update Posted : August 13, 2015
Sponsor:
Information provided by (Responsible Party):
Doaa Adel Salah Khattab, Ain Shams University

Brief Summary:
Free gingival grafts are important to increase zone of attached gingiva and root coverage. This case series reveals role of platelet-rich fibrin (PRF) as adjunctive therapy in palatal wound healing. The superior healing observed at the PRF membrane sites supports its use in accelerating soft-tissue healing. PRF membrane as a palatal bandage is an efficacious approach to protect the raw wound area of a palatal donor site to reduce healing time and patient discomfort.

Condition or disease Intervention/treatment Phase
Platelets Rich Fibrin, Palatal Donor Tissue Biological: Platelets Rich Fibrin in healing of palatal donor tissue Other: Placebo Phase 4

Detailed Description:

Introduction:

Free gingival grafts are one of the common treatment modalities used to increase the zone of keratinized tissue (KT) around implants or prior to ridge augmentation and root coverage. The palatal donor sites had many complications as pain, discomfort and healing by secondary intention. Platelets Rich Fibrin (PRF) is a second generation of platelets concentrate full of growth factors fasten the healing and decrease the pain.

Materials and methods:

Ten patients requiring augmentation of KT participated in this case series. The palatal donor sites of 7 of these patients were covered with PRF membranes with a new suturing technique without palatal stent, the other 3 had palatal stent. Palatal tissue will examined clinically after 3, 7, 10 and 14 days. Considerably very fast healing with 0 pain score was observed during one week in the group with PRF.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Adjunctive Role of Platelets Rich Fibrin in Palatal Wound Healing After Free Gingival Graft Harvesting - Case Series
Study Start Date : January 2014
Actual Primary Completion Date : January 2015

Arm Intervention/treatment
Active Comparator: PRF
Platelets Rich Fibrin
Biological: Platelets Rich Fibrin in healing of palatal donor tissue
Platelets Rich Fibrin (PRF) is a second generation of platelets concentrate full of growth factors as PDGF, IGF, TGF which had a role in hemostasis fasten the healing and decrease the pain.

Placebo Comparator: palatal stent
Palatal stent
Other: Placebo
the other group is a control group, had no biologic in the palatal wound, only palatal stent
Other Name: Palatal stent




Primary Outcome Measures :
  1. Pain Assessment by Visual Analog Scale (VAS) [ Time Frame: 1 week postoperative ]
    VAS ranged from 0 (no pain ) to 10 (severe pain)

  2. Clinical healing of the palate [ Time Frame: 2 weeks postoperative ]
    color match, consistency and thickness of palate (Composite measure)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Systemic free, Good oral hygiene and insufficient attached gingiva prior to ridge augmentation

Exclusion Criteria:

  • High arched palate, medically compromised

Layout table for additonal information
Responsible Party: Doaa Adel Salah Khattab, Assistant Lecturer Oral Periodontology Department, Ain Shams University
ClinicalTrials.gov Identifier: NCT02521467    
Other Study ID Numbers: Doaa Adel
First Posted: August 13, 2015    Key Record Dates
Last Update Posted: August 13, 2015
Last Verified: August 2015