Status:
UNKNOWN
Effectiveness and Safety of Method of Maxilla Alveolar Process Reconstruction Using Synthetic Tricalcium Phosphate and Autologous MMSCs
Lead Sponsor:
Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation
Conditions:
Partially Edentulous Maxilla
Alveolar Bone Atrophy
Eligibility:
All Genders
20-60 years
Phase:
PHASE1
PHASE2
Brief Summary
Autologous MMSCs will be isolated from oral mucosa biopsy sample and expanded in vitro.Tissue engineered construction will be created using synthetic tricalcium phosphate and autologous MMSCs. Patient...
Detailed Description
Patients with verified diagnosis partially edentulous maxilla and alveolar bone atrophy will undergo oral mucosa biopsy and autologous MMSCs will be derived and expanded in vitro during 3-4 weeks. Aft...
Eligibility Criteria
Inclusion
- Partially edentulous maxilla
- 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
- Non-inclusion Criteria:
- 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
- Patient's refusal from the further participation in trial
- 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
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2018
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT02209311
Start Date
September 1 2014
End Date
March 1 2018
Last Update
November 30 2016
Active Locations (2)
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1
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, 121359
2
A.I. Evdokimov Moscow State Medical Stomatological University
Moscow, Russia, 127473