Evaluation of Platelet Rich Fibrin Matrix as Regenerative Material in Intraosseous Defects

NCT03616925 | Completed Phase 3 DMC FDA Drug

• 1 other identifier: KLESociety
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Technological advancement has led to the development of concentrated platelets, by means of centrifugation, popularly known as Platelet concentrates which seem to be a convenient approach to obtain autologous growth factors. Locally delivered platelet concentrates are supposed to increase the proliferation of connective tissue progenitors to stimulate fibroblast and osteoblast activity and enhance angiogenesis, all of which are fundamental to tissue healing and regeneration. Several techniques for platelet concentrates are available, each method leading to a different product with different biology and potential use. Different platelet concentrates are classified, depending on their leucocyte and fibrin content. Conventional platelet rich plasma (PRP), also known as first generation platelet concentrate is plasma with a platelet concentration above the normal physiologic levels found in blood. Platelet Rich Fibrin Matrix (PRFM) is an autologous biologic material created by two step centrifugation of whole blood without the use of exogenous thrombin. Platelets isolated, remain intact and retain their growth factor compliment. This allows a more effective, sustained release of growth factors to the wound site following PRFM application. PRFM possesses the ability to enhance tissue repair by isolation, concentration and preservation of autologous platelets in a dense scaffold like fibrin matrix. The viable platelets contain intrinsic growth factors which are probably released in a desired spatial and temporal manner that affect every aspect of soft tissue and osseous healing. Very limited studies have been conducted to assess the regenerative potential of this new modality i.e. PRFM. This study therefore aims at the evaluation of platelet rich fibrin matrix as a potential regenerative material in comparison with open flap debridement in human periodontal intraosseous defects.

Conditions

Regenerative Inflammation

Outcome Measures

Primary Outcomes (3)

• the clinical change in regenerative potential of platelet rich fibrin matrix (PRFM) and open flap debridement (OFD) and OFD alone in periodontal defects.

  Clinical parameters(plaque index, gingival index, probing pocket depth,attachment level)were combined to assess the change in the regenerative potential

  baseline,3 months and 6 months

• Early wound healing index (EHI) was used to assess the wound healing potential of PRFM

  Early wound healing index (EHI) was used to assess the wound healing potential of PRFM at 1 week.

  1 week

• change in the radiographic parameters in both the groups i.e,PRFM+OFD and OFD alone

  radiographic evidence of bilateral vertical osseous defects were categorized into test group \[OFD + PRFM and control group \[open flap debridement (OFD)\]

  baseline,3 months,6 months

Study Arms (2)

Platelet rich fibrin matrix

EXPERIMENTAL

surgical open flap debridement with Application of Platelet rich fibrin matrix using Platelet Rich Fibrin Matrix kit in 15 intrabony defect sites

Biological: Platelet Rich Fibrin Matrix kit

surgical open flap debridement

ACTIVE COMPARATOR

only surgical open flap debridement was done without application of Platelet rich fibrin matrix in 15 intrabony defect sites

Procedure: surgical open flap debridement

Interventions

Platelet Rich Fibrin Matrix kit BIOLOGICAL

Platelet Rich Fibrin Matrix kit was used to procure platelet rich fibrin matrix using centrifugation machine

Also known as: centrifugation machine

Platelet rich fibrin matrix

surgical open flap debridement PROCEDURE

only surgical open flap debridement was done without use of Platelet Rich Fibrin Matrix kit

surgical open flap debridement

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Systemically healthy patients diagnosed with chronic periodontitis.
• Patients with bilateral infra bony pocket measuring ≥ 6mm with radiographic evidence of intrabony defect.

You may not qualify if:

• Pregnant /lactating women
• Patients taking any drug known to affect the number and function of platelets in the past 3 months.
• Patients with abnormal platelet count.
• Patients with immunologic diseases
• Current smokers.

Sponsors & Collaborators

• KLE Society's Institute of Dental Sciences: lead

Study Sites (1)

Kle Society'S Institute of Dental Sciences

Bengaluru, Karnataka, 560022, India

Location

Study Officials

• Komal D Walia, MDS

  KLE Society's Institute of Dental Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: The patients for this study were selected from the outpatient section of the Department of Periodontics, KLE Society's institute of Dental Sciences, Bangalore, Karnataka. Fifteen patients, aged between 30-55 years (10 males and 5 females) diagnosed with chronic periodontitis, contributing to 30 sites were enrolled for the study by convenience sampling method. It was made clear to the potential subjects that participation was voluntary. Written informed consent was obtained from patients, and ethical clearance for the study was received from the Institutional Ethics Committee (IEC), KLE Society's institute of Dental Sciences, Bangalore. This Randomized controlled trial was carried out from November 2013 to October 2014.

Study Record Dates

• First Submitted: April 8, 2018
• First Posted: August 6, 2018
• Study Start: September 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: November 1, 2014
• Last Updated: August 6, 2018

Record last verified: 2018-08

Locations

IN (1)