Effectiveness and Safety of Method of Maxilla Alveolar Process Reconstruction Using Synthetic Tricalcium Phosphate and Autologous MMSCs

Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation

Status and phase

Unknown

Phase 2

Phase 1

Conditions

Partially Edentulous Maxilla

Alveolar Bone Loss

Alveolar Bone Atrophy

Treatments

Procedure: Oral mucosa biopsy

Device: Dental implant

Procedure: Sinus lift with implantation of tissue engineered construction

Study type

Interventional

Funder types

Other

Identifiers

NCT02209311

RU-CCH-06-01-14

Details and patient eligibility

About

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. Patients will undergo sinus lift procedure with implantation of created tissue-engineered construction. This is a single arm study with no control. All patients receive cell therapy.

Full 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. After that tissue engineered construction will be created using synthetic tricalcium phosphate and autologous MMSCs. Patients will undergo sinus lift procedure with implantation of created tissue-engineered construction. Six months later patients will undergo dental implant installation. Biopsy of bone tissue at the site of sinus lift will be performed as a part of dental implant installation with subsequent histological analysis of bone specimen.

Enrollment

12 estimated patients

Sex

All

Ages

20 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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: