Benefits of Platelet Rich Fibrin In Mandibular Molar Furcation Defects

NCT ID: NCT02430519

Last Updated: 2017-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-05-31

Brief Summary

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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

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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.

Conditions

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Chronic Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, randomized, parallel arm, interventional trial
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
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

Study Groups

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11 Patients with Grade II Manibular Molar Furcation

Group A- Furcation Treatment with PRF

Group Type EXPERIMENTAL

Furcation treatment with PRF

Intervention Type PROCEDURE

PRF Placed into the furcation after flap elevation and debridement

autologous platelet-rich fibrin

Intervention Type DEVICE

11 Patients with Grade II Mandibular Molar Furcation D

Group B- Furcation Treatment with Allograft and GTR

Group Type EXPERIMENTAL

Furcation Treatment with Allograft and GTR

Intervention Type PROCEDURE

Allograft and GTR placed into furcation after flap elevation and debridement

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

Intervention Type DEVICE

Interventions

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Furcation treatment with PRF

PRF Placed into the furcation after flap elevation and debridement

Intervention Type PROCEDURE

Furcation Treatment with Allograft and GTR

Allograft and GTR placed into furcation after flap elevation and debridement

Intervention Type PROCEDURE

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

Intervention Type DEVICE

autologous platelet-rich fibrin

Intervention Type DEVICE

Other Intervention Names

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Furcation Management with Platelet rich fibrin Furcation Management with DFDBM and Healiguide

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dr.Syed Asimuddin

OTHER

Sponsor Role lead

Responsible Party

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Dr.Syed Asimuddin

Post Graduate

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Rekha R Koduganti, MDS(Perio)

Role: STUDY_DIRECTOR

Prof & HOD,Dept of Periodontics,Panineeya Institute of dental sciences

Syed Asimuddin, MDS(Perio)

Role: PRINCIPAL_INVESTIGATOR

PG Student,Panineeya Institute of Dental Sciences

References

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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.

Reference Type RESULT
PMID: 16504852 (View on PubMed)

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.

Reference Type RESULT
PMID: 19878476 (View on PubMed)

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.

Reference Type RESULT
PMID: 9205924 (View on PubMed)

Other Identifiers

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11/98/12

Identifier Type: -

Identifier Source: org_study_id

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