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
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Condition or disease | Intervention/treatment | Phase |
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Edentulous Alveolar Ridge | Drug: Allogenic Mesenchymal stem cells | Early Phase 1 |
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 |
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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.
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Drug: Allogenic Mesenchymal stem cells
Allogenic mesenchymal stem cells are introduced during placement of dental implants.
Other Name: Transchymal |
- 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 |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
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
India | |
Sri Sai College Of Dental Surgery and Research Centre | |
Vikarabad, Telangana State, India, 501101 |
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 |
Publications of Results:
Other Publications:
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. |
Dental Implants Allogenic mesenchymal stem cells osseointegration primary stability resonance frequency analysis |
RFA implants and stem cells use of stem cells stem cells |
Mouth, Edentulous Mouth Diseases Stomatognathic Diseases Tooth Diseases |