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CompletedNCT03578744CPRFGMHATIDUpdated Nov 6, 2018

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

An interventional study of Conventional Flap surgery in Furcation Defects, sponsored by Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre. Completed at 1 site in India. Open to participants aged 30 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-11-06.

Sponsored by Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Nov 2017, registered May 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
14
Allocation
Randomized
Ages
30 Years to 50 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Furcation Defects

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03

In context

Furcation Defects

42 studies on the registry are indexed under Furcation Defects; 13 are open to participants now.

This study's enrollment of 14 is below the median of 27 across 38 interventional studies indexed under Furcation Defects.

Browse Furcation Defects studies →

Lead sponsor

Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre is the lead sponsor of 25 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Grade II furcation involvement

Exclusion criteria

Exclusion Criteria:

  • Smokers,
  • Pregnant and lactating women,
  • Systemically compromised patients
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
14 participants (actual)

Study arms

  • 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.

    Procedure: Conventional Flap surgery

  • 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.

    Procedure: Conventional Flap surgery

Interventions

  • ProcedureConventional 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.

06

What researchers measure

Primary outcomes

  1. Radiological Parameters

    Amount of Bone fill in the furcation (Change in Bone level) to be measured by Cone Beam Computed Tomography(CBCT)

    Time frame: Baseline and 9 months post surgery.

Secondary outcomes

  1. Clinical Parameter

    Change in relative vertical clinical attachment level will be measured by Williams probe in millimeters in the furcation area.

    Time frame: Baseline and 9 months post surgery.

  2. Clinical Parameter

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

    Time frame: Baseline and 9 months post surgery

07

Study locations

1 site
  • Dr.Rekha Rani Koduganti
    Hyderabad, Telangana 500060, India
08

References and documents

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. PubMed 19277899 ↗
  • 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. PubMed 21284545 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2017 to primary completion in Aug 2018, 9 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 31, 2018
First posted
Jul 6, 2018
StartActual
Nov 16, 2017
Primary completionActual
Aug 16, 2018
CompletionActual
Oct 30, 2018
Last update
Nov 6, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 6, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03578744
Lead sponsor
Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
Responsible party
Boyeena Lavanya (Student, Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre) — Principal investigator
First posted
Jul 6, 2018
Start date
Nov 16, 2017
Primary completion
Aug 16, 2018
Completion
Oct 30, 2018
Last update
Nov 6, 2018

Study contacts

Lavanya Boyeena, (MDS)
principal investigator · PG Student

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

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