Effectiveness and Safety of Method of Maxilla Alveolar Process Reconstruction Using Synthetic Tri… (NCT02209311) | Clinical Trial Compass
UnknownPhase 1/2
Effectiveness and Safety of Method of Maxilla Alveolar Process Reconstruction Using Synthetic Tricalcium Phosphate and Autologous MMSCs
Russia12 participantsStarted 2014-09
Plain-language 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. 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.
Who can participate
Age range20 Years – 60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 t…
What they're measuring
1
Number of serious adverse events (SAEs) and serious adverse reactions (SARs)
Timeframe: 1 week after treatment
Trial details
NCT IDNCT02209311
SponsorCentral Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation