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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Periodontitis
• Intervention / Treatment: Procedure: Furcation treatment with PRF; Device: autologous platelet-rich fibrin; Procedure: Furcation Treatment with Allograft and GTR; Device: allograft and guided tissue regeneration (GTR) membrane (DFDBM and Healiguide)

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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 11 Patients with Grade II Manibular Molar Furcation; Group A- Furcation Treatment with PRF	Procedure: Furcation treatment with PRF; PRF Placed into the furcation after flap elevation and debridement; Other Names: Furcation Management with Platelet rich fibrin; 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; Allograft and GTR placed into furcation after flap elevation and debridement; Other Names: Furcation Management with DFDBM and Healiguide; Device: allograft and guided tissue regeneration (GTR) membrane (DFDBM and Healiguide)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vertical clinical attacment level	The Vertical clinical attachment level was assessed preoperatively and 9 months after surgery	9 months Post treatment
Horizontal clinical attachment level	The horizontal clinical attachment level was assessed preoperatively and 9 months after surgery.	9 months Post treatment
Bone fill	Bone fill was assessed radiographically and 9 months after surgery	9 months Post treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plaque Index	Plaque index was assessed preoperatively and 9 months after surgery	9 Months Post treatment
Probing depth	Probing depth was assessed preoperatively and 9 months after surgery	9 Months Post treatment
Gingival marginal level	Gingival marginal level was assessed preoperatively and 9 months after surgery	9 months post treatment

Collaborators and Investigators

• Sponsor: Dr.Syed Asimuddin
• Investigators: Study Director: Rekha R Koduganti, MDS(Perio), Prof & HOD,Dept of Periodontics,Panineeya Institute of dental sciences; Principal Investigator: Syed Asimuddin, MDS(Perio), PG Student,Panineeya Institute of Dental Sciences

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: April 18, 2015
• First Submitted That Met QC Criteria: April 29, 2015
• First Posted (Estimate): April 30, 2015

Study Record Updates

• Last Update Posted (Actual): April 7, 2017
• Last Update Submitted That Met QC Criteria: April 5, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Chronic Periodontitis; Furcation defects; Clinical Parameters; Radiographic bone fill
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Chronic Periodontitis; Furcation Defects
• Other Study ID Numbers: 11/98/12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO