Furcation DefectsCPRFGMHATIDNCT03578744
Comparison of Platelet Rich Fibrin as Graft & Membrane Vs Hyaluronic Acid & Amniotic Membrane in the Treatment of Interradicular Defects
A study testing Conventional Flap surgery in people with Furcation Defects, run by Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Furcation Defects
- What is being tested?
- Conventional Flap surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteIndia
- Study dates
- 16 Nov 2017to 30 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Grade II furcation involvement
Who cannot join
- Smokers,
- Pregnant and lactating women,
- Systemically compromised patients
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Furcation Defects
- Being tested
- Conventional Flap surgery
- Medical subject headings
- Furcation Defects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Flap surgeryProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | 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. Receives: Procedure: Conventional Flap surgery |
| Interventional Comparator | Experimental | 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. Receives: Procedure: Conventional Flap surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiological Parameters
Amount of Bone fill in the furcation (Change in Bone level) to be measured by Cone Beam Computed Tomography(CBCT)
Measured: Baseline and 9 months post surgery.
Secondary outcomes (2)
Clinical Parameter
Change in relative vertical clinical attachment level will be measured by Williams probe in millimeters in the furcation area.
Measured: Baseline and 9 months post surgery.
Clinical Parameter
Change in relative horizontal clinical attachment level will be measured in millimeters by the Nabers probe in the furcation area
Measured: Baseline and 9 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2018
- Study start16 Nov 2017
- Primary completion16 Aug 2018
- Study completion30 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Furcation DefectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Boyeena Lavanya, Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
- Investigators
- Lavanya Boyeena, (MDS), Principal investigator, PG Student
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03578744
- Sponsor's protocol ID
- PMIDS
- Other IDs
- 16201105031D
- Acronym
- CPRFGMHATID
- Status last verified
- Nov 2018
- First submitted
- 31 May 2018
- Last updated
- 6 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 19277899Sharma 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
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03578744
- Acronym / sponsor ID
- CPRFGMHATID / PMIDS
- Conditions
- Furcation Defects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Panineeya Mahavidyalaya Institute of Dental Sciences & Research CentreUniversity, hospital or other
- Study start
- 16 Nov 2017 (actual)
- Primary completion
- 16 Aug 2018 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 6 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Procedure: Conventional Flap surgeryGroup 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. |
| Interventional Comparator | Experimental | Procedure: Conventional Flap surgeryGroup 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. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Grade II furcation involvement
Key exclusion criteria (3 listed)
- Smokers,
- Pregnant and lactating women,
- Systemically compromised patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional Flap surgeryAfter 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. | Procedure or surgery | Interventional, Interventional Comparator |
Primary outcome
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)
2 secondary outcomes
Clinical Parameter
Time frame: Baseline and 9 months post surgery.
Clinical Parameter
Time frame: Baseline and 9 months post surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2018.
- Background: PubMed 19277899Kothiwale 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.
- Background: PubMed 21284545Sharma 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.
- Individual participant dataSharing planned: No
Related trials for Furcation Defects
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Injectable Platelet-Rich Fibrin With Minimally Invasive Non-Surgical Technique in Treatment of Grade II Furcation Defects
Injectable Platelet-Rich Fibrin, Minimally Invasive
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Enamel Matrix Derivative and Xenograft for Mandibular Molar Furcation Defects
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Morphological Characteristics of Mandibular Molar Furcation Involvement and Efficacy of Regenerative Surgical Treatment
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lavanya Boyeena, (MDS) principal investigator
PG Student
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Flap surgery in people with Furcation Defects, run by Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiological Parameters (time frame: Baseline and 9 months post surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03578744, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2018.