NCT03044119

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 6, 2017

Completed
1.1 years until next milestone

Study Start

First participant enrolled

March 15, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2019

Completed
Last Updated

January 16, 2019

Status Verified

January 1, 2019

Enrollment Period

1.3 years

First QC Date

February 2, 2017

Last Update Submit

January 14, 2019

Conditions

Dental Implants

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Implant stability quotient (ISQ) using Resonance frequency analysis (RFA).

    3 months

Study Arms (2)

Dental Implant with PRFM

ACTIVE COMPARATOR

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

Dental Implant with PRFM and PBMSCs

EXPERIMENTAL

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

Interventions

Dental Implant with PRFMBIOLOGICAL

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

Dental Implant with PRFM
Dental Implant with PRFM and PBMSCsBIOLOGICAL

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.

Dental Implant with PRFM and PBMSCs

Eligibility Criteria

Age25 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kle Society'S Institute of Dental Sciences

Bengaluru, Karnataka, 560022, India

RECRUITING

MeSH Terms

Interventions

Dental Implants

Intervention Hierarchy (Ancestors)

Dental MaterialsBiomedical and Dental MaterialsDental ProsthesisProsthodonticsDentistryProstheses and ImplantsEquipment and SuppliesManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Sudhir R Patil, MDS

    KLE Society's Institute of Dental Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Laveena Singhal, 1 MDS

CONTACT

9900330579laveenasinghal13@gmail.com

Sphoorthi A Belludi, MDS

CONTACT

9916010380doc_sphoo@yahoo.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The selected sites would be randomly (coin toss method) assigned into an edentulous area .
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Laveena

Study Record Dates

First Submitted

February 2, 2017

First Posted

February 6, 2017

Study Start

March 15, 2018

Primary Completion

July 20, 2019

Study Completion

October 20, 2019

Last Updated

January 16, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will share

in the form of research publication

Locations

IN(1)