Benefits of Platelet Rich Fibrin In Mandibular Molar Furcation Defects

NCT02430519 | Completed

• 1 other identifier: 11/98/12
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Periodontitis

Keywords

Chronic Periodontitis; Clinical Parameters; Furcation defects; Radiographic bone fill

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Plaque Index

  9 Months Post treatment

• Probing depth

  9 Months Post treatment

• Gingival marginal level

  9 months post treatment

Study Arms (2)

11 Patients with Grade II Manibular Molar Furcation

EXPERIMENTAL

Group A- Furcation Treatment with PRF

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

11 Patients with Grade II Mandibular Molar Furcation D

EXPERIMENTAL

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

Furcation treatment with PRF PROCEDURE

PRF Placed into the furcation after flap elevation and debridement

Also known as: Furcation Management with Platelet rich fibrin

11 Patients with Grade II Manibular Molar Furcation

Furcation Treatment with Allograft and GTR PROCEDURE

Allograft and GTR placed into furcation after flap elevation and debridement

Also known as: Furcation Management with DFDBM and Healiguide

11 Patients with Grade II Mandibular Molar Furcation D

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

11 Patients with Grade II Mandibular Molar Furcation D

autologous platelet-rich fibrin DEVICE

11 Patients with Grade II Manibular Molar Furcation

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr.Syed Asimuddin: lead

Related Publications (3)

• 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.

  PMID: 16504852 RESULT

• 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.

  PMID: 19878476 RESULT

• 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.

  PMID: 9205924 RESULT

MeSH Terms

Conditions

Chronic Periodontitis; Furcation Defects

Interventions

Prolactin-Releasing Hormone; Transplantation, Homologous; Guided Tissue Regeneration

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins; Transplantation; Surgical Procedures, Operative; Plastic Surgery Procedures

Study Officials

• Rekha R Koduganti, MDS(Perio)

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

  STUDY DIRECTOR

• Syed Asimuddin, MDS(Perio)

  PG Student,Panineeya Institute of Dental Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Post Graduate

Model Details: Prospective, randomized, parallel arm, interventional trial

Study Record Dates

• First Submitted: April 18, 2015
• First Posted: April 30, 2015
• Study Start: September 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: April 7, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share