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Chronic PeriodontitisPRFMMFDNCT02430519

Benefits of Platelet Rich Fibrin In Mandibular Molar Furcation Defects

A study testing Furcation treatment with PRF, Furcation Treatment with Allograft and GTR and allograft and guided tissue regeneration (GTR) membrane (DFDBM and Healiguide) in people with Chronic Periodontitis, run by Dr.Syed Asimuddin.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Background: Furcation is the bifurcation or trifurcation of a multirooted tooth. It is an area of complex anatomic morphology difficult to debride by routine periodontal instrumentation. Read more about this study

Who is it for?
Ages 30 to 50 years
Conditions the study is for
Chronic Periodontitis
What is being tested?
Furcation treatment with PRF, Furcation Treatment with Allograft and GTR and allograft and guided tissue regeneration (GTR) membrane (DFDBM and Healiguide)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
No sites listed yet
Study dates
Sep 2012to May 2013
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
  • No healthy volunteers
  • Adult

Who may be able to join

  • One or more sites showing grade II furcation involvement in mandibular molars, with Probing pocket depth ≥ 5mm
  • Vertical attachment level and horizontal level ≥3mm were considered.
  • Patients who were systemically healthy, with no history of endodontic and periodontal treatment for the last 6 months, and no antibiotic usage for the last 6 months were included in the study. Care was taken to ascertain that the samples taken for the study were not allergic to any drugs nor to the graft materials used.

Who cannot join

  • Patients with a history of diabetes, hypertension, on anticoagulant or steroid therapy (which could alter the effects of PRF), cardiac diseases, insufficient platelet counts and immunocompromised individuals were excluded from the study.
  • Care was taken to exclude pregnant women and lactating mothers, smokers, patients with previous history of graft placement in the experimental site, and importantly those patients who were unable to maintain good oral hygiene (PI Score ≥ 1.5).
  • If Grade II mobility was observed after phase I therapy in the experimental teeth, they were excluded

About this study

Official title: Effect of Autologous Platelet Rich Fibrin In Human Mandibular Molar Grade II Furcation Defects- A Clinical and Radiological Study

Background: Furcation is the bifurcation or trifurcation of a multirooted tooth. It is an area of complex anatomic morphology difficult to debride by routine periodontal instrumentation. Multiple approaches have been used in an effort to treat the furcation Choukroun's platelet-rich fibrin (PRF), a second generation platelet concentrate has biochemical components which have well known synergetic effects on healing processes. The present study was conducted to evaluate the effectiveness of autologous platelet-rich fibrin (PRF) in the treatment of mandibular molar Grade 2 furcation defects in comparison to allograft and guided tissue regeneration (GTR) membrane.

Read the detailed description

ABSTRACT Background: Furcation is the bifurcation or trifurcation of a multirooted tooth. It is an area of complex anatomic morphology difficult to debride by routine periodontal instrumentation. Multiple approaches have been used in an effort to treat the furcation Choukroun's platelet-rich fibrin (PRF), a second generation platelet concentrate has biochemical components which have well known synergetic effects on healing processes. The present study was conducted to evaluate the effectiveness of autologous platelet-rich fibrin (PRF) in the treatment of mandibular molar Grade 2 furcation defects in comparison to allograft and guided tissue regeneration (GTR) membrane. MATERIALS AND METHODS: The study was designed as a randomized, prospective, parallel-arm, interventional clinical trial wherein 30 patients with periodontitis and grade II Mandibular furcation defects attending the Out Patient wing of the Department of Periodontics of a tertiary referral care hospital were equally divided into group A and group B. Patients in.Group A, were treated by the placement of PRF as a Graft and as a membrane at the surgical site , while in Group B, the defects were treated by the placement of Allograft and Healiguide collagen membrane. Plaque Index, Probing depth, Vertical clinical attachment level, Horizontal clinical attachment level, Gingival marginal level, and amount of bonefill using Radiovisiography were recorded at baseline and 9 months. Intra-group comparison of Mean scores between Group A and Group B was done using Paired t test and Inter-group comparison using independent sample t test. CONCLUSION Further studies evaluating the efficacy of PRF using a larger sample size should be performed to evaluate its true beneficial effects on long term basis in patients with mandibular molar Grade 2 furcation defects.

Being tested
Furcation treatment with PRF, Furcation Treatment with Allograft and GTR, allograft and guided tissue regeneration (GTR) membrane (DFDBM and Healiguide), autologous platelet-rich fibrin
Keywords
Chronic Periodontitis, Clinical Parameters, Furcation defects, Radiographic bone fill
Medical subject headings
Chronic Periodontitis, Furcation Defects

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Furcation treatment with PRFProcedure or surgery

    Also called Furcation Management with Platelet rich fibrin

    PRF Placed into the furcation after flap elevation and debridement

  • Furcation Treatment with Allograft and GTRProcedure or surgery

    Also called Furcation Management with DFDBM and Healiguide

    Allograft and GTR placed into furcation after flap elevation and debridement

  • allograft and guided tissue regeneration (GTR) membrane (DFDBM and Healiguide)Device

  • autologous platelet-rich fibrinDevice

Study groups in NCT02430519
Study groupRoleWhat they receive
11 Patients with Grade II Manibular Molar FurcationExperimentalGroup A- Furcation Treatment with PRF
Receives: Procedure: Furcation treatment with PRF; Device: autologous platelet-rich fibrin
11 Patients with Grade II Mandibular Molar Furcation DExperimentalGroup B- Furcation Treatment with Allograft and GTR
Receives: Procedure: Furcation Treatment with Allograft and GTR; Device: allograft and guided tissue regeneration (GTR) membrane (DFDBM and Healiguide)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Vertical clinical attacment level

    The Vertical clinical attachment level was assessed preoperatively and 9 months after surgery

    Measured: 9 months Post treatment

  2. Horizontal clinical attachment level

    The horizontal clinical attachment level was assessed preoperatively and 9 months after surgery.

    Measured: 9 months Post treatment

  3. Bone fill

    Bone fill was assessed radiographically and 9 months after surgery

    Measured: 9 months Post treatment

Secondary outcomes (3)

  1. Plaque Index

    Plaque index was assessed preoperatively and 9 months after surgery

    Measured: 9 Months Post treatment

  2. Probing depth

    Probing depth was assessed preoperatively and 9 months after surgery

    Measured: 9 Months Post treatment

  3. Gingival marginal level

    Gingival marginal level was assessed preoperatively and 9 months after surgery

    Measured: 9 months post treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2015 (estimated)
  2. Study startSep 2012
  3. Primary completionMay 2013
  4. Study completionMay 2013

Resources

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
Prospective, randomized, parallel arm, interventional trial
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02430519
Sponsor's protocol ID
11/98/12
Acronym
PRFMMFD
Status last verified
Apr 2017
First submitted
18 Apr 2015
Last updated
7 Apr 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Choukroun J, Diss A, Simonpieri A, Girard MO, Schoeffler C, Dohan SL, Dohan AJ, Mouhyi J, Dohan DM. Platelet-rich fibrin (PRF): a second-generation platelet concentrate. Part IV: clinical effects on tissue healing. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Mar;101(3):e56-60. doi: 10.1016/j.tripleo.2005.07.011.

    PubMed 16504852

  • Bosshardt DD, Sculean A. Does periodontal tissue regeneration really work? Periodontol 2000. 2009;51:208-19. doi: 10.1111/j.1600-0757.2009.00317.x. No abstract available.

    PubMed 19878476

  • Luepke PG, Mellonig JT, Brunsvold MA. A clinical evaluation of a bioresorbable barrier with and without decalcified freeze-dried bone allograft in the treatment of molar furcations. J Clin Periodontol. 1997 Jun;24(6):440-6. doi: 10.1111/j.1600-051x.1997.tb00209.x.

    PubMed 9205924

Questions about this trial

What is this clinical trial studying?

A study testing Furcation treatment with PRF, Furcation Treatment with Allograft and GTR and allograft and guided tissue regeneration (GTR) membrane (DFDBM and Healiguide) in people with Chronic Periodontitis, run by Dr.Syed Asimuddin.

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 3 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 7 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

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?

Vertical clinical attacment level (time frame: 9 months Post treatment). The study lists 3 primary outcomes in all. 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 NCT02430519, which also lists 3 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 7 Apr 2017.

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