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

Primary Purpose

Partially Edentulous Maxilla, Alveolar Bone Atrophy, Alveolar Bone Loss

Status
Unknown status
Phase
Phase 1
Locations
Russian Federation
Study Type
Interventional
Intervention
Oral mucosa biopsy
Sinus lift with implantation of tissue engineered construction
Dental implant
Sponsored by
Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Partially Edentulous Maxilla focused on measuring 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

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept 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:

  • Perforation of the Schneider's membrane more than 5 mm on the stage of the sinus-lift operation
  • Pregnancy

Sites / Locations

  • 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
  • A.I. Evdokimov Moscow State Medical Stomatological University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tissue engineered construction implantation

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Quality of life monitoring
Quality of life estimated by validated questionnaire: the Short Form (36) Health Survey (SF-36).
Changes in bone tissue volume
Changes in volume and density of bone tissue at the site of manipulation and newly formed bone micro-architecture assessed by cone beam CT (morphometrical analysis using Hounsfield unit measurements)
Correlation of morphometrical analysis using cone beam CT scan with absolute value of the newly formed bone
Biopsy of bone tissue at the site of sinus lift will be performed as a part of dental implant installation. Bone sample will be evaluated histologically: absolute value of the newly formed bone will be calculated using histomorphometrical analysis.

Full Information

First Posted
August 4, 2014
Last Updated
November 29, 2016
Sponsor
Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation
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1. Study Identification

Unique Protocol Identification Number
NCT02209311
Brief Title
Effectiveness and Safety of Method of Maxilla Alveolar Process Reconstruction Using Synthetic Tricalcium Phosphate and Autologous MMSCs
Official Title
Effectiveness and Safety of Method of Maxilla Alveolar Process Reconstruction Using Tissue Engineered Construction Based on a Synthetic Tricalcium Phosphate and Autologous Multipotent Mesenchymal Stromal Cells Obtained From Oral Mucosa
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
March 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tissue engineered construction implantation
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Oral mucosa biopsy
Intervention Type
Procedure
Intervention Name(s)
Sinus lift with implantation of tissue engineered construction
Intervention Type
Device
Intervention Name(s)
Dental implant
Primary Outcome Measure Information:
Title
Number of serious adverse events (SAEs) and serious adverse reactions (SARs)
Time Frame
1 week after treatment
Secondary Outcome Measure Information:
Title
Quality of life monitoring
Description
Quality of life estimated by validated questionnaire: the Short Form (36) Health Survey (SF-36).
Time Frame
up to 24 weeks after treatment
Title
Changes in bone tissue volume
Description
Changes in volume and density of bone tissue at the site of manipulation and newly formed bone micro-architecture assessed by cone beam CT (morphometrical analysis using Hounsfield unit measurements)
Time Frame
up to 24 weeks after treatment
Title
Correlation of morphometrical analysis using cone beam CT scan with absolute value of the newly formed bone
Description
Biopsy of bone tissue at the site of sinus lift will be performed as a part of dental implant installation. Bone sample will be evaluated histologically: absolute value of the newly formed bone will be calculated using histomorphometrical analysis.
Time Frame
24 weeks after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: Perforation of the Schneider's membrane more than 5 mm on the stage of the sinus-lift operation Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grigory Volozhin A Volozhin, MD, PhD
Organizational Affiliation
A.I. Evdokimov Moscow State Medical Stomatological University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ilya I Eremin, MD, PhD
Organizational Affiliation
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
Official's Role
Principal Investigator
Facility Information:
Facility Name
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
City
Moscow
ZIP/Postal Code
121359
Country
Russian Federation
Facility Name
A.I. Evdokimov Moscow State Medical Stomatological University
City
Moscow
ZIP/Postal Code
127473
Country
Russian Federation

12. IPD Sharing Statement

Learn more about this trial

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

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