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

NCT ID: NCT03578744

Last Updated: 2018-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-16

Study Completion Date

2018-10-30

Brief Summary

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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

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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.

Conditions

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Furcation Defects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Sealed envelopes.

Study Groups

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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.

Group Type EXPERIMENTAL

Conventional Flap surgery

Intervention Type PROCEDURE

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.

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.

Group Type EXPERIMENTAL

Conventional Flap surgery

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Grade II furcation involvement

Exclusion Criteria

* Smokers,
* Pregnant and lactating women,
* Systemically compromised patients
Minimum Eligible Age

30 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre

OTHER

Sponsor Role lead

Responsible Party

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Boyeena Lavanya

Student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lavanya Boyeena, (MDS)

Role: PRINCIPAL_INVESTIGATOR

PG Student

Locations

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Dr.Rekha Rani Koduganti

Hyderabad, Telangana, India

Site Status

Countries

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India

References

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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.

Reference Type BACKGROUND
PMID: 19277899 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21284545 (View on PubMed)

Other Identifiers

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16201105031D

Identifier Type: OTHER

Identifier Source: secondary_id

PMIDS

Identifier Type: -

Identifier Source: org_study_id

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