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

NCT02209311 | Unknown Phase 1

• 1 other identifier: RU-CCH-06-01-14
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

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. 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.

Conditions

Partially Edentulous Maxilla; Alveolar Bone Atrophy; Alveolar Bone Loss

Keywords

Alveolar Bone Loss; Alveolar Bone Atrophy; Dental Implantation; Bone Tissue Reconstruction; Sinus Lift; Autologous Multipotent Mesenchymal Stem Cell; Autologous MMSCs; Synthetic Tricalcium Phosphate; Tissue Engineered Construction; Oral Mucosa

Outcome Measures

Primary Outcomes (1)

• Number of serious adverse events (SAEs) and serious adverse reactions (SARs)

  1 week after treatment

Secondary Outcomes (3)

• Quality of life monitoring

  up to 24 weeks after treatment

• Changes in bone tissue volume

  up to 24 weeks after treatment

• Correlation of morphometrical analysis using cone beam CT scan with absolute value of the newly formed bone

  24 weeks after treatment

Study Arms (1)

Tissue engineered construction implantation

EXPERIMENTAL

Procedure: Oral mucosa biopsy; Procedure: Sinus lift with implantation of tissue engineered construction; Device: Dental implant

Interventions

Oral mucosa biopsy PROCEDURE

Tissue engineered construction implantation

Sinus lift with implantation of tissue engineered construction PROCEDURE

Tissue engineered construction implantation

Dental implant DEVICE

Tissue engineered construction implantation

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (2)

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, 121359, Russia

Location

A.I. Evdokimov Moscow State Medical Stomatological University

Moscow, 127473, Russia

Location

MeSH Terms

Conditions

Alveolar Bone Loss

Interventions

Dental Implants

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Materials; Biomedical and Dental Materials; Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Grigory Volozhin A Volozhin, MD, PhD

  A.I. Evdokimov Moscow State Medical Stomatological University

  PRINCIPAL INVESTIGATOR

• Ilya I Eremin, MD, PhD

  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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2014
• First Posted: August 5, 2014
• Study Start: September 1, 2014
• Primary Completion: October 1, 2017
• Study Completion: March 1, 2018
• Last Updated: November 30, 2016

Record last verified: 2016-11

Locations

RU (2)