PRF for Accelerating Palatal Healing

March 14, 2016 updated by: Onur Ozcelik, Cukurova University

The Effects of Platelet-Rich Fibrin on Palatal Wound Healing After Free Gingival Graft Harvesting: A Comparative Randomized Controlled Clinical Trial

Backgroung: Various agents are used to reduce post-operative complications associated with palatal donor site surgery for free gingival graft (FGG) harvesting. This study was conducted to evaluate the effects of platelet-rich fibrin (PRF) on palatal wound healing.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

125 patients with isolated recessions were treated. The connective tissue graft was obtained by the de-epithelialization of a free gingival graft in both groups. Three different hemostatic treatments were randomized; PRF with cyanoacrilate adhesive (PRF group, n:42), cyanoacrilate adhesive alone (BC group, n:42) and sterile wet gauze compression (WG group, n:41). Immediate and delayed bleeding, pain, epithelialization, feeding habits and sensation scores were recorded for different time points.

Study Type

Interventional

Enrollment (Actual)

125

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

21 years to 48 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • no contraindications for periodontal surgery;
  • full-mouth plaque score of <10%
  • full-mouth bleeding score of <15%.

Exclusion Criteria:

  • previously undergone surgery for a graft harvested from the palate
  • presence of systemic disease or taking medication known to interfere with periodontal health
  • smokers
  • possible coagulation disorders

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Platelet Rich Fibrin
PRF was laid directly on the palatal wound immediately after harvesting the tissue graft and stabilized
Other: Platelet Rich Fibrin
Immediate and delayed bleeding, pain, epithelialization, feeding habits and sensation scores were recorded after PRF placing on palatal wounds.
ACTIVE_COMPARATOR: Butyl cyanoacrylate
Butyl cyanoacrylate was directly applied on the palatal wound after harvesting the tissue graft
Other: Butyl cyanoacrylate
Immediate and delayed bleeding, pain, epithelialization, feeding habits and sensation scores were recorded after Butyl Cyanoacrylate application on palatal wounds.
PLACEBO_COMPARATOR: Wet Gauze
Wet Gauze was placed for 1 minute on the palatal wound after harvesting the tissue graft
Other: Wet gauze
Immediate and delayed bleeding, pain, epithelialization, feeding habits and sensation scores were recorded after wet gauze pressure on palatal wounds.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Epithelialization
Time Frame: One month
Assessed according to the toluedine blue coloring
One month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensibility disorders
Time Frame: One month
visual analogue scale scores
One month
feeding habits
Time Frame: One month
visual analogue scale scores
One month
Delayed bleeding
Time Frame: 1 week
Bleeding assesment for post-operative one week
1 week
Immediate Bleeding
Time Frame: 1 hour
Bleeding assesment for post-operative one hour
1 hour
Pain
Time Frame: 3 months
Visual Analague Scale scores
3 months

Collaborators and Investigators

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

Sponsor

Cukurova University

Investigators

  • Study Director: Onur Ozcelik, Ph D, Cukurova University, Professor

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

November 1, 2013

Primary Completion (ACTUAL)

May 1, 2015

Study Completion (ACTUAL)

September 1, 2015

Study Registration Dates

First Submitted

March 9, 2016

First Submitted That Met QC Criteria

March 14, 2016

First Posted (ESTIMATE)

March 18, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

March 18, 2016

Last Update Submitted That Met QC Criteria

March 14, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CukurovaU8

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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.

Clinical Trials on Gingival Recession

Clinical Trials on Platelet Rich Fibrin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Madagascar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe