Platelet Rich Fibrin in the Treatment of Multiple Gingival Recessions

December 20, 2013 updated by: Asude Merve Polat, Ege University

Comparison of Platelet Rich Fibrin and Connective Tissue Graft in Treatment of Multiple Gingival Recessions

The aim of this randomized controlled clinical study is to evaluate and compare the effectiveness of platelet rich fibrin (PRF) and connective tissue grafts in the treatment of multiple gingival recessions.

Study Overview

Detailed Description

The aim of this randomized controlled clinical study is to evaluate and compare the effectiveness of platelet rich fibrin (PRF) and connective tissue grafts in the treatment of multiple gingival recessions.

Primary outcome variables were percentage of complete root coverage and mean root coverage percentages at 6 months follow up. The secondary outcome variables include keratinized tissue and gingival thickness gain.

Sample size has been estimated as 13 in each treatment arm. All recessions are treated with modified coronally advanced flap. On test sites PRF membrane and on control sites connective tissue grafts will be placed under modified coronally advanced flaps. Random allocation of the treatment sites to test and control groups were performed using a computer software designed for randomization.

Clinical parameters such as gingival index, plaque index, keratinized tissue width, gingival recession depth and width were measured at 1, 3 and 6 months. Probing pocket depth, clinical attachment level, gingival thickness and gingival recession area were measure at baseline and 6 months. All gingival recession-related parameters such as recession height, recession width and recession area and keratinized tissue width along with mean root coverage and complete root coverage were assessed on standardized clinical photographs using an image analysis software.

Clinical photographs were obtained at baseline and 1, 3 and 6 months after surgical intervention. 4 mm length wire was placed on gingiva to check reproducibility and to obtain standardized pictures.

Gingival tissue thickness were measured with an #15 endodontic reamer attached to rubber stopper inserted perpendicularly into the gingival tissue 2 mm below the gingival margin; thickness of the reamer will be measured with a digital caliper.

Mean root coverage percentage was calculated as percentage of covered root surface area at 6 months.

Follow up of subjects was 6 months.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Bornova
      • Izmir, Bornova, Turkey, 35100
        • Ege University School of Dentistry Department of Periodontology

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Two or more adjacent teeth with at least 2 mm Miller Class I gingival recessions at non-molar teeth
  • Identifiable CEJ on all teeth
  • Age ≥ 18
  • Presence of tooth vitality and absence of restorations and superficial caries in the treatment area
  • No past surgical treatment history of affected area.
  • Gingival thickness ≥ 0,8 mm for recession areas.
  • Sufficient palatal donor tissue for connective tissue harvesting.

Exclusion Criteria:

  • Smoking
  • Pregnancy or lactation
  • Systematic diseases that may affect outcomes of periodontal therapy
  • Self-reported antibiotic medication within three months
  • Occlusal trauma in treatment site

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: connective tissue graft
connective tissue graft harvested from palatum of subjects and placed under modified coronally advanced flap
Experimental: Platelet rich fibrin
Autogenous platelet rich fibrin was obtained from subjects own blood samples after centrifugation. Platelet rich fibrin membranes were placed under modified coronally advanced flaps.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean root coverage percentage
Time Frame: 6 months
mean area of root coverage achieved by surgical root coverage therapy.
6 months
complete root coverage percentage
Time Frame: 6 months
percentage of gingival recession defects completely covered by flaps after 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
keratinized tissue width
Time Frame: 6 months
changes in keratinized tissue width at 6 months
6 months
gingival tissue thickness
Time Frame: 6 months
changes from baseline in gingival tissue thickness at 6 months
6 months

Collaborators and Investigators

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

Sponsor

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

May 1, 2012

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

December 17, 2013

First Submitted That Met QC Criteria

December 20, 2013

First Posted (Estimate)

December 23, 2013

Study Record Updates

Last Update Posted (Estimate)

December 23, 2013

Last Update Submitted That Met QC Criteria

December 20, 2013

Last Verified

December 1, 2013

More Information

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.

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