Clinical trial NCT03578744: Comparison of Platelet Rich Fibrin as Graft & Membrane Vs Hyaluronic Acid & Amniotic Membrane in the Treatment of Interradicular Defects
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
Overall status: COMPLETED
Phase: NA
Conditions: Furcation Defects
Lead sponsor: Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
Sponsor class: OTHER
First posted: 2018-07-06
Enrollment: 14
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Grade II furcation involvement

Exclusion Criteria:

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

Primary outcomes:
measure: Radiological Parameters
timeFrame: Baseline and 9 months post surgery.
Secondary outcomes:
measure: Clinical Parameter
timeFrame: Baseline and 9 months post surgery.
measure: Clinical Parameter
timeFrame: Baseline and 9 months post surgery
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Dr.Rekha Rani Koduganti
state: Telangana
Study officials:
affiliation: PG Student
name: Lavanya Boyeena, (MDS)
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.