The Effect of Platelet Rich Fibrin Matrix With and Without Peripheral Blood Mesenchymal Stem Cells on Implant Stability

A Comparative Evaluation of the Effect of Platelet Rich Fibrin Matrix With and Without Peripheral Blood Mesenchymal Stem Cells on Implant Stability : A Randomized Controlled Clinical Trial

The Primary Objectives of the present study are :

• To Evaluate the effect of platelet rich fibrin matrix (PRFM) and peripheral blood mesenchymal stem cells (PBMSCs) on implant stability.
• To Compare the effect of platelet rich fibrin matrix (PRFM) alone to peripheral blood mesenchymal stem cells (PBMSCs) embedded in platelet rich fibrin matrix (PRFM) on implant stability.

Study Overview

• Status: Unknown
• Conditions: Dental Implants
• Intervention / Treatment: Biological: Dental Implant with PRFM; Biological: Dental Implant with PRFM and PBMSCs

Detailed Description

The addition of molecules or growth factors to the implant surface is an approach to enhance bone to implant contact (BIC).1 Platelet rich fibrin matrix (PRFM) is an autologous concentrated platelet-rich thrombin free fibrin matrix, prepared by two step centrifugation of blood. 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.2 During the second spin, a cross-linking of fibrin takes place, resulting in the formation of a dense fibrin matrix, within which a concentration of viable platelets can be found. Having an organized fibrin matrix at the start of healing accelerates the speed of vascular ingress into the wound compared to non-accelerated healing, which requires a longer time for fibrin formation and the development of vascularity. The earlier the vascularity is established, faster is the migration of the bone-forming cells at the wound site and initiation of bone formation. Therapeutic applications of platelet-rich products have led to improved bone regeneration and faster titanium implant osseointegration, which improve the stability and maintenance of dental implants by increasing BIC.1 Mesenchymal stem cells (MSCs) is a multipotent stromal cell with prominent regenerative functions. MSCs were first identified and isolated from bone marrow and then found in various tissues including umbilical cord, adipose tissue and peripheral blood. Among these sources peripheral blood MSCs draw increasing attention as they share similar biological characteristics with MSCs derived from bone marrow or adipose tissue. Bone marrow derived mesenchymal stem cells(BMMSCs) are multipotent cells capable of differentiating into osteoblasts, chondrocytes, adipocytes , fibroblasts, tenocytes, and myoblasts , which are considered as a cell source for various tissue repair and regenerating bone defects.3 The requirements of aspiration of bone marrow from the patient will cause pain and morbidity of the donor sites. It will be very convenient if peripheral blood mesenchymal stem cells (PBMSCs) could be harvested and expanded to enough numbers, with their osteogenic capacity maintained in a clinical permitted period.

The literature search does not show any human clinical trial conducted till date to assess the regenerative potential of this new modality i.e. PRFM and peripheral blood mesenchymal stem cells. This study therefore aims at the evaluation of PRFM and PBMSCs as regenerative materials for implant stability.

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Phase 1

Contacts and Locations

Study Locations

• India
  • Karnataka
    • Bengaluru, Karnataka, India, 560022
      • Recruiting
      • Kle Society'S Institute of Dental Sciences
      • Contact: laveena singhal, mds; Phone Number: 9900330579; Email: laveenasinghal13@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient with age group between 25-50 years
• Radiographic imaging(IOPA/OPG/CBCT/RVG) of the area of interest showing sufficient residual bone volume to receive two or more adjacent implants of ≥ 3.5 mm in diameter and 11.0 mm in length
• Extraction at least 6 months prior to the study.

Exclusion Criteria:

• Para-functional habits
• Smoking more than 10 cigarettes per day
• Excessive consumption of alcohol
• Patient's with systemic diseases contraindicated for surgery
• Localized radiotherapy, Antitumor chemotherapy of the oral cavity
• Liver, blood, and/or kidney diseases
• Immunosuppression
• Current corticosteroid or bisphosphonate use;
• Pregnancy
• Mucocutaneous diseases involving the oral cavity and
• Poor oral hygiene.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dental Implant with PRFM; Intervention in the form of Dental Implants placement in the adjacent edentulous bone with the placement of platelet rich fibrin matrix a biological material procured from patient's peripheral blood	Biological: Dental Implant with PRFM; placement of a minimum of two adjacent dental implants being randomly assigned into (G1) - Dental implant with PRFM
Experimental: Dental Implant with PRFM and PBMSCs; Intervention in the form of Dental Implant placement in the adjacent edentulous bone with the placement of platelet rich fibrin matrix and peripheral blood mesenchymal stem cells which are the biological materials procured from patient's peripheral blood	Biological: Dental Implant with PRFM and PBMSCs; placement of a minimum of two adjacent dental implants being randomly assigned into (G2) - Dental implant with peripheral blood mesenchymal stem cells embedded in PRFM.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insertion torque values at the time of placement of dental implant	insertion torque values will be recorded during the day of placement of implants.	on the implant placement day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant stability quotient (ISQ) using Resonance frequency analysis (RFA).	Implant stability quotient (ISQ) using Resonance frequency analysis (RFA) with the help of Osstell device at 1 week, 1 month and 3 months post operatively	3 months

Collaborators and Investigators

• Sponsor: KLE Society's Institute of Dental Sciences
• Investigators: Principal Investigator: Sudhir R Patil, MDS, Kle Society'S Institute of Dental Sciences

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2018
• Primary Completion (Anticipated): July 20, 2019
• Study Completion (Anticipated): October 20, 2019

Study Registration Dates

• First Submitted: February 2, 2017
• First Submitted That Met QC Criteria: February 2, 2017
• First Posted (Estimate): February 6, 2017

Study Record Updates

• Last Update Posted (Actual): January 16, 2019
• Last Update Submitted That Met QC Criteria: January 14, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: KLESInstitute

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: in the form of research publication

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No