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

Furcation Defects Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03578744
• Other study ID #: PMIDS
• Secondary ID: 16201105031D
• Status: Completed
• Phase: N/A
• Start date: November 16, 2017
• Est. completion date: October 30, 2018

Study information

• Verified date: November 2018
• Source: Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: October 30, 2018
• Est. primary completion date: August 16, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 50 Years

Eligibility

Inclusion Criteria:

• Grade II furcation involvement

Exclusion Criteria:

• Smokers,

• Pregnant and lactating women,

• Systemically compromised patients

Related Conditions & MeSH terms

• Furcation Defects

Intervention

Procedure:
• Conventional Flap surgery
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.

Locations

Country	Name	City	State
India	Dr.Rekha Rani Koduganti	Hyderabad	Telangana

Sponsors (1)

Lead Sponsor	Collaborator
Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre

Country where clinical trial is conducted

India, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiological Parameters	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	Clinical Parameter	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.
Secondary	Clinical Parameter	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