Comparison of Platelet Rich Fibrin as Graft & Membrane Vs Hyaluronic Acid & Amniotic Membrane in the Treatment of Interradicular Defects (CPRFGMHATID)
Primary Purpose
Furcation Defects
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Conventional Flap surgery
Sponsored by
About this trial
This is an interventional treatment trial for Furcation Defects
Eligibility Criteria
Inclusion Criteria:
- Grade II furcation involvement
Exclusion Criteria:
- Smokers,
- Pregnant and lactating women,
- Systemically compromised patients
Sites / Locations
- Dr.Rekha Rani Koduganti
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Interventional
Interventional Comparator
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Radiological Parameters
Amount of Bone fill in the furcation (Change in Bone level) to be measured by Cone Beam Computed Tomography(CBCT)
Secondary Outcome Measures
Clinical Parameter
Change in relative vertical clinical attachment level will be measured by Williams probe in millimeters in the furcation area.
Clinical Parameter
Change in relative horizontal clinical attachment level will be measured in millimeters by the Nabers probe in the furcation area
Full Information
NCT ID
NCT03578744
First Posted
May 31, 2018
Last Updated
November 5, 2018
Sponsor
Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
1. Study Identification
Unique Protocol Identification Number
NCT03578744
Brief Title
Comparison of Platelet Rich Fibrin as Graft & Membrane Vs Hyaluronic Acid & Amniotic Membrane in the Treatment of Interradicular Defects
Acronym
CPRFGMHATID
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
November 16, 2017 (Actual)
Primary Completion Date
August 16, 2018 (Actual)
Study Completion Date
October 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Furcation Defects
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will be equally divided into two test groups, Group A and Group B after phase I therapy. The group A patients will be treated with conventional flap surgery and the furcation would be debrided, following which platelet-rich fibrin will be placed as a graft and a membrane. The flap will then be sutured back. The group B patients will also be treated with conventional flap surgery after furcation area is debrided, and hyaluronic acid (gengigel)will be placed as a graft over which amniotic membrane will be placed. The flap would then be sutured.
Masking
Participant
Masking Description
Sealed envelopes.
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Interventional
Arm Type
Experimental
Arm Description
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.
Arm Title
Interventional Comparator
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Conventional Flap surgery
Intervention Description
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.
Primary Outcome Measure Information:
Title
Radiological Parameters
Description
Amount of Bone fill in the furcation (Change in Bone level) to be measured by Cone Beam Computed Tomography(CBCT)
Time Frame
Baseline and 9 months post surgery.
Secondary Outcome Measure Information:
Title
Clinical Parameter
Description
Change in relative vertical clinical attachment level will be measured by Williams probe in millimeters in the furcation area.
Time Frame
Baseline and 9 months post surgery.
Title
Clinical Parameter
Description
Change in relative horizontal clinical attachment level will be measured in millimeters by the Nabers probe in the furcation area
Time Frame
Baseline and 9 months post surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Grade II furcation involvement
Exclusion Criteria:
Smokers,
Pregnant and lactating women,
Systemically compromised patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lavanya Boyeena, (MDS)
Organizational Affiliation
PG Student
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr.Rekha Rani Koduganti
City
Hyderabad
State/Province
Telangana
ZIP/Postal Code
500060
Country
India
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
19277899
Citation
Kothiwale SV, Anuroopa P, Gajiwala AL. A clinical and radiological evaluation of DFDBA with amniotic membrane versus bovine derived xenograft with amniotic membrane in human periodontal grade II furcation defects. Cell Tissue Bank. 2009 Nov;10(4):317-26. doi: 10.1007/s10561-009-9126-3. Epub 2009 Mar 10.
Results Reference
background
PubMed Identifier
21284545
Citation
Sharma A, Pradeep AR. Autologous platelet-rich fibrin in the treatment of mandibular degree II furcation defects: a randomized clinical trial. J Periodontol. 2011 Oct;82(10):1396-403. doi: 10.1902/jop.2011.100731. Epub 2011 Feb 2.
Results Reference
background
Learn more about this trial
Comparison of Platelet Rich Fibrin as Graft & Membrane Vs Hyaluronic Acid & Amniotic Membrane in the Treatment of Interradicular Defects
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