Effectiveness and Safety of Method of Maxilla Alveolar Process Reconstruction Using Synthetic Tricalcium Phosphate and Autologous MMSCs
NCT ID: NCT02209311
Last Updated: 2016-11-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
12 participants
INTERVENTIONAL
2014-09-30
2018-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Tissue engineered construction implantation
Oral mucosa biopsy
Sinus lift with implantation of tissue engineered construction
Dental implant
Interventions
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Oral mucosa biopsy
Sinus lift with implantation of tissue engineered construction
Dental implant
Eligibility Criteria
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Inclusion Criteria
* Height of the bone tissue in the area of reconstruction 1 - 5 mm according to results of cone-beam computed tomography
* Minimal height of the augmentation - 8 mm
* Volume of bone tissue deficiency of the alveolar process of the maxilla 3 - 5 cm3
* Implant installation scheduled to be at least 6 months after sinus-lift operation
* Patient is familiar with Participant information sheet
* Patient signed informed consent form
* Chronic and acute ear, nose and throat diseases, including maxillary sinusitis, foreign bodies in the maxillary sinus, odontogenic and not odontogenic maxillary sinus cyst
* Medical history of surgery on maxillary sinuses during preceding 6 months prior to implantation of tissue engineered construction
* Progressive somatic disease (clinically significant diseases of the cardiovascular, hematopoietic or endocrine system, systemic diseases, immunopathological states)
* Patients with malignant tumors including postoperative period, patients receiving chemotherapy and/or radiotherapy
* Any conditions limiting compliance (dementia, neuropsychiatric disease, drug and alcohol abuse etc.)
* Significant weight loss (\> 10% of body weight in the previous year) of unknown etiology
* Patient prescribed for any medications with proven effect on bone metabolism
* Diabetes mellitus, disorders of thyroid and parathyroid glands
* Clinically significant abnormalities in results of laboratory tests
* Participation in other clinical trials (or administration of investigational drugs) during 3 months prior inclusion
Exclusion Criteria
* Patient's refusal from compliance with the requirements of contraception during the participation in research
* Plaque index (PI)\> 15%
* Sulcus bleeding index (SBI) \> 10%
* Chronic kidney disease IV - V stages (creatinine clearance \< 30 mL/min estimated by Cockroft-Gault formula)
* Confirmed syphilis, HIV, hepatitis B or C infections
Dropout Criteria:
* Perforation of the Schneider's membrane more than 5 mm on the stage of the sinus-lift operation
* Pregnancy
20 Years
60 Years
ALL
No
Sponsors
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Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation
OTHER_GOV
Responsible Party
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Principal Investigators
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Grigory Volozhin A Volozhin, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
A.I. Evdokimov Moscow State Medical Stomatological University
Ilya I Eremin, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Federal State Budgetary Institution "Central Clinical Hospital with Outpatient Health Center" of the Business Administration for the President of the Russian Federation; Center for Biomedical Technologies
Locations
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Federal State Budgetary Institution "Central Clinical Hospital with Outpatient Health Center" of the Business Administration for the President of the Russian Federation; Center for Biomedical Technologies
Moscow, , Russia
A.I. Evdokimov Moscow State Medical Stomatological University
Moscow, , Russia
Countries
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Other Identifiers
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RU-CCH-06-01-14
Identifier Type: -
Identifier Source: org_study_id