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CompletedNCT02430519PRFMMFDUpdated Apr 7, 2017

Benefits of Platelet Rich Fibrin In Mandibular Molar Furcation Defects

An interventional study of Furcation treatment with PRF and Furcation Treatment with Allograft and GTR in Chronic Periodontitis, sponsored by Dr.Syed Asimuddin. Completed. Open to participants aged 30 Years to 50 Years. Per ClinicalTrials.gov, last updated 2017-04-07.

Sponsored by Dr.Syed Asimuddin · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Randomized
Ages
30 Years to 50 Years
Sex
All
01

Study 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. 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.

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Conditions studied

  • Chronic Periodontitis

Keywords

  • Chronic Periodontitis
  • Clinical Parameters
  • Furcation defects
  • Radiographic bone fill
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Who can participate

Ages eligible
30 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
22 participants (actual)

Study arms

  • Experimental
    11 Patients with Grade II Manibular Molar Furcation

    Group A- Furcation Treatment with PRF

    Procedure: Furcation treatment with PRF · Device: autologous platelet-rich fibrin

  • Experimental
    11 Patients with Grade II Mandibular Molar Furcation D

    Group B- Furcation Treatment with Allograft and GTR

    Procedure: Furcation Treatment with Allograft and GTR · Device: allograft and guided tissue regeneration (GTR) membrane (DFDBM and Healiguide)

Interventions

  • ProcedureFurcation treatment with PRF

    PRF Placed into the furcation after flap elevation and debridement

    Also known as: Furcation Management with Platelet rich fibrin

  • ProcedureFurcation Treatment with Allograft and GTR

    Allograft and GTR placed into furcation after flap elevation and debridement

    Also known as: Furcation Management with DFDBM and Healiguide

  • Deviceallograft and guided tissue regeneration (GTR) membrane (DFDBM and Healiguide)
  • Deviceautologous platelet-rich fibrin
05

What researchers measure

Primary outcomes

  1. Vertical clinical attacment level

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

    Time frame: 9 months Post treatment

  2. Horizontal clinical attachment level

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

    Time frame: 9 months Post treatment

  3. Bone fill

    Bone fill was assessed radiographically and 9 months after surgery

    Time frame: 9 months Post treatment

Secondary outcomes

  1. Plaque Index

    Plaque index was assessed preoperatively and 9 months after surgery

    Time frame: 9 Months Post treatment

  2. Probing depth

    Probing depth was assessed preoperatively and 9 months after surgery

    Time frame: 9 Months Post treatment

  3. Gingival marginal level

    Gingival marginal level was assessed preoperatively and 9 months after surgery

    Time frame: 9 months post treatment

06

Study locations

No study locations are listed for this record.

07

References and documents

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 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT02430519
Lead sponsor
Dr.Syed Asimuddin
Responsible party
Dr.Syed Asimuddin (Post Graduate, Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre) — Sponsor-investigator
First posted
Apr 30, 2015
Start date
Sep 2012
Primary completion
May 2013
Completion
May 2013
Last update
Apr 7, 2017

Study contacts

Rekha R Koduganti, MDS(Perio)
study director · Prof & HOD,Dept of Periodontics,Panineeya Institute of dental sciences
Syed Asimuddin, MDS(Perio)
principal investigator · PG Student,Panineeya Institute of Dental Sciences

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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