Clinical trial NCT02430519: Benefits of Platelet Rich Fibrin In Mandibular Molar Furcation Defects
Official title: Effect of Autologous Platelet Rich Fibrin In Human Mandibular Molar Grade II Furcation Defects- A Clinical and Radiological Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Periodontitis
Keywords: Chronic Periodontitis
Clinical Parameters
Furcation defects
Radiographic bone fill
Lead sponsor: Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
Sponsor class: OTHER
First posted: 2015-04-30
Enrollment: 22
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, parallel arm, interventional trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Vertical clinical attacment level
timeFrame: 9 months Post treatment
measure: Horizontal clinical attachment level
timeFrame: 9 months Post treatment
measure: Bone fill
timeFrame: 9 months Post treatment
Secondary outcomes:
measure: Plaque Index
timeFrame: 9 Months Post treatment
measure: Probing depth
timeFrame: 9 Months Post treatment
measure: Gingival marginal level
timeFrame: 9 months post treatment
Other outcomes:
Locations:
Study officials:
affiliation: Prof & HOD,Dept of Periodontics,Panineeya Institute of dental sciences
name: Rekha R Koduganti, MDS(Perio)
role: STUDY_DIRECTOR
affiliation: PG Student,Panineeya Institute of Dental Sciences
name: Syed Asimuddin, MDS(Perio)
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.