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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

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03044119
Enrollment
15
Registered
2017-02-06
Start date
2018-03-15
Completion date
2019-10-20
Last updated
2019-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Implants

Brief summary

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.

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.

Interventions

BIOLOGICALDental Implant with PRFM

placement of a minimum of two adjacent dental implants being randomly assigned into (G1) - Dental implant with PRFM

BIOLOGICALDental 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.

Sponsors

KLE Society's Institute of Dental Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

The selected sites would be randomly (coin toss method) assigned into an edentulous area .

Intervention model description

The selected sites would be randomly (coin toss method) assigned into an edentulous area allowing for the placement of a minimum of two adjacent dental implants being randomly assigned into (G1) - Dental implant with PRFM and (G2) - Dental implant with peripheral blood mesenchymal stem cells embedded in PRFM.

Eligibility

Sex/Gender
ALL
Age
25 Years to 50 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Insertion torque values at the time of placement of dental implanton the implant placement dayinsertion torque values will be recorded during the day of placement of implants.

Secondary

MeasureTime frameDescription
Implant stability quotient (ISQ) using Resonance frequency analysis (RFA).3 monthsImplant stability quotient (ISQ) using Resonance frequency analysis (RFA) with the help of Osstell device at 1 week, 1 month and 3 months post operatively

Countries

India

Contacts

Primary ContactLaveena Singhal, 1 MDS
laveenasinghal13@gmail.com9900330579
Backup ContactSphoorthi A Belludi, MDS
doc_sphoo@yahoo.com9916010380

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026