- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03578744
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Telangana
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Hyderabad, Telangana, India, 500060
- Dr.Rekha Rani Koduganti
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Grade II furcation involvement
Exclusion Criteria:
- Smokers,
- Pregnant and lactating women,
- Systemically compromised patients
Study Plan
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)
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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.
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Baseline and 9 months post surgery.
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Clinical Parameter
Time Frame: Baseline and 9 months post surgery
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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
Investigators
- Principal Investigator: Lavanya Boyeena, (MDS), PG student
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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