Comparison of Platelet Rich Fibrin as Graft & Membrane Vs Hyaluronic Acid & Amniotic Membrane in the Treatment of Interradicular Defects (CPRFGMHATID)

Efficacy of Platelet Rich Fibrin as a Graft and Membrane Versus Hyaluronic Acid and Amniotic Membrane in the Treatment of Mandibular Grade II and Grade III Furcation Defects- A Randomized Clinical Trial

This study is intended to compare the efficacy of platelet-rich fibrin as a graft and a membrane versus hyaluronic acid(Gengigel) and amniotic membrane in the treatment of mandibular grade II furcation defects.

Study Overview

Status

Completed

Conditions

Detailed Description

Platelet-rich fibrin is a fraction of plasma that provides a rich source of growth factors and may enhance the stabilization and revascularization of the flaps and grafts.

Hyaluronic acid is a naturally occurring non-sulfated high molecular weight glycosaminoglycan that forms a critical component of the extracellular matrix and contributes significantly to tissue hydrodynamics, cell migration and proliferation. Hence its administration to periodontal wound sites could achieve beneficial effects in periodontal tissue regeneration.

Amniotic membrane is being used for various regenerative procedures as it is a rich source of various collagen and non-collagen proteins such as laminin, fibronectin and proteoglycan.

Study Type

Interventional

Enrollment (Actual)

14

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

    • Telangana
      • Hyderabad, Telangana, India, 500060
        • Dr.Rekha Rani Koduganti

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

30 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Grade II furcation involvement

Exclusion Criteria:

  • Smokers,
  • Pregnant and lactating women,
  • Systemically compromised patients

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: Interventional
Group A patients will be treated with conventional flap surgery. The furcation defects will be debrided and autologous platelet-rich fibrin will be paced as a graft and membrane. Later the flap will be sutured.
After administering local anaesthetic a full thickness flap will be raised and reflected to expose the furcation defects. The furcation defects would then be debrided and the graft and membrane secured in position. Later the flap would be sutured back.
EXPERIMENTAL: Interventional Comparator
Group B patients will be treated with conventional flap surgery. The furcation defects will be debrided and Hyaluronic acid (Gengigel) will be placed as a graft. Amniotic membrane (Tata Memorial Hospital Mumbai) will be placed over the graft and later the flap will be sutured.
After administering local anaesthetic a full thickness flap will be raised and reflected to expose the furcation defects. The furcation defects would then be debrided and the graft and membrane secured in position. Later the flap would be sutured back.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiological Parameters
Time Frame: Baseline and 9 months post surgery.
Amount of Bone fill in the furcation (Change in Bone level) to be measured by Cone Beam Computed Tomography(CBCT)
Baseline and 9 months post surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Parameter
Time Frame: Baseline and 9 months post surgery.
Change in relative vertical clinical attachment level will be measured by Williams probe in millimeters in the furcation area.
Baseline and 9 months post surgery.
Clinical Parameter
Time Frame: Baseline and 9 months post surgery
Change in relative horizontal clinical attachment level will be measured in millimeters by the Nabers probe in the furcation area
Baseline and 9 months post surgery

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Lavanya Boyeena, (MDS), PG student

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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 (ACTUAL)

November 16, 2017

Primary Completion (ACTUAL)

August 16, 2018

Study Completion (ACTUAL)

October 30, 2018

Study Registration Dates

First Submitted

May 31, 2018

First Submitted That Met QC Criteria

July 4, 2018

First Posted (ACTUAL)

July 6, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 6, 2018

Last Update Submitted That Met QC Criteria

November 5, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • PMIDS
  • 16201105031D (OTHER: Kaloji Narayana Rao University of Health Sciences.)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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