search
Back to results

Benefits of Platelet Rich Fibrin In Mandibular Molar Furcation Defects (PRFMMFD)

Primary Purpose

Chronic Periodontitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Furcation treatment with PRF
Furcation Treatment with Allograft and GTR
allograft and guided tissue regeneration (GTR) membrane (DFDBM and Healiguide)
autologous platelet-rich fibrin
Sponsored by
Dr.Syed Asimuddin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Periodontitis focused on measuring Chronic Periodontitis, Clinical Parameters, Furcation defects, Radiographic bone fill

Eligibility Criteria

30 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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:

  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    11 Patients with Grade II Manibular Molar Furcation

    11 Patients with Grade II Mandibular Molar Furcation D

    Arm Description

    Group A- Furcation Treatment with PRF

    Group B- Furcation Treatment with Allograft and GTR

    Outcomes

    Primary Outcome Measures

    Vertical clinical attacment level
    The Vertical clinical attachment level was assessed preoperatively and 9 months after surgery
    Horizontal clinical attachment level
    The horizontal clinical attachment level was assessed preoperatively and 9 months after surgery.
    Bone fill
    Bone fill was assessed radiographically and 9 months after surgery

    Secondary Outcome Measures

    Plaque Index
    Plaque index was assessed preoperatively and 9 months after surgery
    Probing depth
    Probing depth was assessed preoperatively and 9 months after surgery
    Gingival marginal level
    Gingival marginal level was assessed preoperatively and 9 months after surgery

    Full Information

    First Posted
    April 18, 2015
    Last Updated
    April 5, 2017
    Sponsor
    Dr.Syed Asimuddin
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02430519
    Brief Title
    Benefits of Platelet Rich Fibrin In Mandibular Molar Furcation Defects
    Acronym
    PRFMMFD
    Official Title
    Effect of Autologous Platelet Rich Fibrin In Human Mandibular Molar Grade II Furcation Defects- A Clinical and Radiological Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2012 (undefined)
    Primary Completion Date
    May 2013 (Actual)
    Study Completion Date
    May 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Dr.Syed Asimuddin

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Periodontitis
    Keywords
    Chronic Periodontitis, Clinical Parameters, Furcation defects, Radiographic bone fill

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Prospective, randomized, parallel arm, interventional trial
    Masking
    ParticipantInvestigator
    Masking Description
    The eligible samples were screened and randomly assigned by lottery method by investigator KRR into PRF (Group A) and GTR + Allograft (Group B). The treatment was performed by investigator SA who was blinded to the randomization process
    Allocation
    Randomized
    Enrollment
    22 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    11 Patients with Grade II Manibular Molar Furcation
    Arm Type
    Experimental
    Arm Description
    Group A- Furcation Treatment with PRF
    Arm Title
    11 Patients with Grade II Mandibular Molar Furcation D
    Arm Type
    Experimental
    Arm Description
    Group B- Furcation Treatment with Allograft and GTR
    Intervention Type
    Procedure
    Intervention Name(s)
    Furcation treatment with PRF
    Other Intervention Name(s)
    Furcation Management with Platelet rich fibrin
    Intervention Description
    PRF Placed into the furcation after flap elevation and debridement
    Intervention Type
    Procedure
    Intervention Name(s)
    Furcation Treatment with Allograft and GTR
    Other Intervention Name(s)
    Furcation Management with DFDBM and Healiguide
    Intervention Description
    Allograft and GTR placed into furcation after flap elevation and debridement
    Intervention Type
    Device
    Intervention Name(s)
    allograft and guided tissue regeneration (GTR) membrane (DFDBM and Healiguide)
    Intervention Type
    Device
    Intervention Name(s)
    autologous platelet-rich fibrin
    Primary Outcome Measure Information:
    Title
    Vertical clinical attacment level
    Description
    The Vertical clinical attachment level was assessed preoperatively and 9 months after surgery
    Time Frame
    9 months Post treatment
    Title
    Horizontal clinical attachment level
    Description
    The horizontal clinical attachment level was assessed preoperatively and 9 months after surgery.
    Time Frame
    9 months Post treatment
    Title
    Bone fill
    Description
    Bone fill was assessed radiographically and 9 months after surgery
    Time Frame
    9 months Post treatment
    Secondary Outcome Measure Information:
    Title
    Plaque Index
    Description
    Plaque index was assessed preoperatively and 9 months after surgery
    Time Frame
    9 Months Post treatment
    Title
    Probing depth
    Description
    Probing depth was assessed preoperatively and 9 months after surgery
    Time Frame
    9 Months Post treatment
    Title
    Gingival marginal level
    Description
    Gingival marginal level was assessed preoperatively and 9 months after surgery
    Time Frame
    9 months post treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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: 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Rekha R Koduganti, MDS(Perio)
    Organizational Affiliation
    Prof & HOD,Dept of Periodontics,Panineeya Institute of dental sciences
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Syed Asimuddin, MDS(Perio)
    Organizational Affiliation
    PG Student,Panineeya Institute of Dental Sciences
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    16504852
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    19878476
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    9205924
    Citation
    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.
    Results Reference
    result

    Learn more about this trial

    Benefits of Platelet Rich Fibrin In Mandibular Molar Furcation Defects

    We'll reach out to this number within 24 hrs