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NCT Number: NCT03578744

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

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.

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Key information

Conditions

Furcation Defects Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr.Rekha Rani Koduganti

Hyderabad, Telangana, 500060, India

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Grade II furcation involvement

Exclusion criteria

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

Treatment and study plan

Conventional Flap surgery

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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.

  2. Clinical Parameter

    Time frame: Baseline and 9 months post surgery

    Change in relative horizontal clinical attachment level will be measured in millimeters by the Nabers probe in the furcation area

Sponsors and collaborators

Lead sponsor

Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre

Other

Registry information

Official study 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

Acronym: CPRFGMHATID

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 6, 2018
Registry last updated
Nov 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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