Effect on Allogenic Mesenchymal Stem Cells on Osseointegration of Dental Implants

NCT02731586 | Unknown Early Phase 1 DMC

• 1 other identifier: SSCDS-IMP-201601
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Edentulous Alveolar Ridge

Keywords

Dental Implants; Allogenic mesenchymal stem cells; osseointegration; primary stability; resonance frequency analysis; RFA; implants and stem cells; use of stem cells; stem cells

Outcome Measures

Primary Outcomes (1)

• Determination of Implant Stability with RFA

  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.

  3 months

Study Arms (1)

osseointegration using Allogenic MSC's

EXPERIMENTAL

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

Interventions

Allogenic Mesenchymal stem cells DRUG

Allogenic mesenchymal stem cells are introduced during placement of dental implants.

Also known as: Transchymal

osseointegration using Allogenic MSC's

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Sri Sai College of Dental Surgery and Research Centre: lead

Study Sites (1)

Sri Sai College Of Dental Surgery and Research Centre

Vikārābād, Telangana State, 501101, India

Location

Related Publications (6)

• Haniffa MA, Collin MP, Buckley CD, Dazzi F. Mesenchymal stem cells: the fibroblasts' new clothes? Haematologica. 2009 Feb;94(2):258-63. doi: 10.3324/haematol.13699. Epub 2008 Dec 23.

  PMID: 19109217 BACKGROUND

• Uccelli A, Moretta L, Pistoia V. Mesenchymal stem cells in health and disease. Nat Rev Immunol. 2008 Sep;8(9):726-36. doi: 10.1038/nri2395.

  PMID: 19172693 RESULT

• Le Blanc K, Tammik C, Rosendahl K, Zetterberg E, Ringden O. HLA expression and immunologic properties of differentiated and undifferentiated mesenchymal stem cells. Exp Hematol. 2003 Oct;31(10):890-6. doi: 10.1016/s0301-472x(03)00110-3.

  PMID: 14550804 RESULT

• Meredith N. Assessment of implant stability as a prognostic determinant. Int J Prosthodont. 1998 Sep-Oct;11(5):491-501.

  PMID: 9922740 RESULT

• Lavenus S, Berreur M, Trichet V, Pilet P, Louarn G, Layrolle P. Adhesion and osteogenic differentiation of human mesenchymal stem cells on titanium nanopores. Eur Cell Mater. 2011 Aug 26;22:84-96; discussion 96. doi: 10.22203/ecm.v022a07.

  PMID: 21870339 RESULT

• Limet R. [Advantages of side-to-side anastomosis in coronary surgery[(author's transl)]]. Acta Chir Belg. 1976 Jul;75(4):390-401. French.

  PMID: 1087820 RESULT

Related Links

• Osseointegration
• The Coailation Of Americans For Research Ethics
• Voice of Stemcell Research Community
• Stem Cell Research Facts

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Shailaja Reddy, (MDS)

  Sri Sai College of Dental Surgery and Research Centre

  STUDY DIRECTOR

• Mahendranadh Reddy Kareti, MDS

  Sri Sai College of Dental Surgery and Research Centre

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2016
• First Posted: April 7, 2016
• Study Start: January 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: March 1, 2018
• Last Updated: October 6, 2017

Record last verified: 2017-10

Locations

IN (1)