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Effect on Allogenic Mesenchymal Stem Cells on Osseointegration of Dental Implants (MSC&IMPLANTS)

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ClinicalTrials.gov Identifier: NCT02731586
Recruitment Status : Unknown
Verified October 2017 by Sri Sai College of Dental Surgery and Research Centre.
Recruitment status was:  Enrolling by invitation
First Posted : April 7, 2016
Last Update Posted : October 6, 2017
Sponsor:
Information provided by (Responsible Party):
Sri Sai College of Dental Surgery and Research Centre

Brief Summary:
As Regenerative Medicine is the next level in medicinal sciences, the use of mesenchymal cells have become prevalent, Similarly now stem cells are being used in dental research as well in various clinical applications.This study aims to evaluate the overall effect of osseointegration by use of Allogenic Mesenchymal Stem cells while placing dental implants.Healthy subjects will be chosen and dental implants placed bilaterally one with standard surgical protocol and other with the use of Allogenic Mesenchymal Stem cells.The implant stability is checked using Resonance frequency analysis(RFA).The RFA values are statistically evaluated at various intervals and observations will be analysed on both test and control side.

Condition or disease Intervention/treatment Phase
Edentulous Alveolar Ridge Drug: Allogenic Mesenchymal stem cells Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Comparative Clinical Evaluation of Osseointegration of Dental Implants Placed With and Without, the Use of Dental Pulp-derived Allogenic Mesenchymal Stem Cells.
Actual Study Start Date : January 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : March 2018

Arm Intervention/treatment
Experimental: osseointegration using Allogenic MSC's
Evaluation of Osseointegration of Dental Implants to be done using Allogenic Mesenchymal Stem Cells.Primary and Secondary stability are measured using RFA.
Drug: Allogenic Mesenchymal stem cells
Allogenic mesenchymal stem cells are introduced during placement of dental implants.
Other Name: Transchymal




Primary Outcome Measures :
  1. Determination of Implant Stability with RFA [ Time Frame: 3 months ]
    Dental Implant stability is a measure of primary stability and secondary stability.The Implant stability can be perceived as a combination of Mechanical stability, which is the result of compressed bone holding the implant tightly in place (Primary Stability) and biological stability, which is the result of new bone cells forming at the site of the implant and resultant osseointegration(Secondary stability).The Implant Stability Quotient (ISQ) is a scale of measurement developed by Osstell device for use with the Resonance Frequency Analysis (RFA) method of measuring implant stability. The Implant Stability Quotient is a linear mapping from resonance frequency measured in kHz to the more clinically useful scale of 1-100 ISQ. The higher the ISQ, the more stable is the implant. The Implant stability is measured every fortnight for three months in 10 patients.The values on test side and control side are plotted on the graph and analysed.



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Patients with bilateral edentulous condition either partial or complete.
  2. Patients maintaining adequate oral hygiene
  3. Patients with dimensions of alveolar jaw bone in Occlusso-Gingival position >10mm and Bucco-Lingual position < 6mm.

Exclusion Criteria:

  1. Systemic diseases which are likely to compromise Implant surgery like Diabetes Mellitus Type I, II and Osteoporosis.
  2. Patients with oral parafunctional habits like Bruxism.
  3. Smokers who smoke more than 10 cigarettes a day.
  4. Self-declared pregnancy or intention to become Pregnant.
  5. The use of Regenerative procedures in conjunction with Implant placement.Eg- Grafts ,Sinus Lift procedures.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02731586


Locations
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India
Sri Sai College Of Dental Surgery and Research Centre
Vikarabad, Telangana State, India, 501101
Sponsors and Collaborators
Sri Sai College of Dental Surgery and Research Centre
Investigators
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Principal Investigator: Mohammed Sufath UR Rehman, (MDS) Sri Sai College of Dental Surgery and Research Centre
Principal Investigator: Venkat Aditya, MDS Sri Sai College of Dental Surgery and Research Centre
Study Director: Shailaja Reddy, (MDS) Sri Sai College of Dental Surgery and Research Centre
Study Chair: Mahendranadh Reddy Kareti, MDS Sri Sai College of Dental Surgery and Research Centre
Additional Information:
Publications of Results:
Other Publications:
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Responsible Party: Sri Sai College of Dental Surgery and Research Centre
ClinicalTrials.gov Identifier: NCT02731586    
Other Study ID Numbers: SSCDS-IMP-201601
First Posted: April 7, 2016    Key Record Dates
Last Update Posted: October 6, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: upon total enrollment of participants, it shall be decided.
Keywords provided by Sri Sai College of Dental Surgery and Research Centre:
Dental Implants
Allogenic mesenchymal stem cells
osseointegration
primary stability
resonance frequency analysis
RFA
implants and stem cells
use of stem cells
stem cells
Additional relevant MeSH terms:
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Mouth, Edentulous
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases