Partially Edentulous MaxillaPhase 1/2NCT02209311

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

A Phase 1/2 study testing Oral mucosa biopsy, Sinus lift with implantation of tissue engineered construction and Dental implant in people with Partially Edentulous Maxilla and Alveolar Bone Atrophy, run by Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation at 2 sites in Russia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 20 to 60 years
Conditions the study is for: Partially Edentulous Maxilla, Alveolar Bone Atrophy, Alveolar Bone Loss
What is being tested?: Oral mucosa biopsy, Sinus lift with implantation of tissue engineered construction and Dental implant
Type of treatment: Pill or oral medicine, Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 2 sitesRussia
Study dates: Sep 2014to Mar 2018
Phase: Phase 1/2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

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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

Who cannot join

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

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

Trial locations and contacts

2 sites in 1 country.

Russia2 sites

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
A.I. Evdokimov Moscow State Medical Stomatological University
Moscow, 127473

Other trials in Russia

About this study

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

Read the 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.

Conditions: Partially Edentulous Maxilla, Alveolar Bone Atrophy, Alveolar Bone Loss
Being tested: Oral mucosa biopsy, Sinus lift with implantation of tissue engineered construction, Dental implant
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
Medical subject headings: Alveolar Bone Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Oral mucosa biopsyProcedure or surgery
Sinus lift with implantation of tissue engineered constructionProcedure or surgery
Dental implantDevice

Study groups in NCT02209311
Study group	Role	What they receive
Tissue engineered construction implantation	Experimental	Not described Receives: Procedure: Oral mucosa biopsy; Procedure: Sinus lift with implantation of tissue engineered construction; Device: Dental implant

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of serious adverse events (SAEs) and serious adverse reactions (SARs)
Measured: 1 week after treatment

Secondary outcomes (3)

Quality of life monitoring
Quality of life estimated by validated questionnaire: the Short Form (36) Health Survey (SF-36).
Measured: up to 24 weeks after treatment
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)
Measured: up to 24 weeks after treatment
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.
Measured: 24 weeks after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2014Mar 2018

First posted5 Aug 2014 (estimated)
Study startSep 2014
Primary completionOct 2017 (estimated)
Study completionMar 2018 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Partially Edentulous MaxillaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 12 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02209311
Sponsor's protocol ID: RU-CCH-06-01-14
Status last verified: Nov 2016
First submitted: 4 Aug 2014
Last updated: 30 Nov 2016
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Clinical and Radiographic Evaluation of UV-Treated Dental Implants With or Without Melatonin in the Upper Posterior Jaw
Jaw, Edentulous, Partially, Bone Resorption
Not yet recruitingEarly Phase 1
Radiographic Changes in the Maxillary Sinus Following Closed Sinus Augmentation With Leukocyte Platelet Rich Fibrin
Partially Edentulous Maxilla
Active, not recruiting
Non-Guided vs. Guided Surgery to Immediately Loaded PrimeTaper Implants in Partially Edentulous Patients
Partially Edentulous Maxilla or Mandible
Active, not recruiting
Dimensional Changes in Single Crowns Supported by Short Transmucosal Implants With Diverging or Converging Neck Profiles in the Esthetic Zone
Edentulous Alveolar Ridge
Active, not recruiting
Fully Versus Partially Guided Implants Placement: Measurement of Accuracy of Implant Position and Passivity of Superstructures.
Completely Edentulous, Implant Assesment

All Partially Edentulous Maxilla trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02209311
Acronym / sponsor ID: RU-CCH-06-01-14
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
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 12 participants (estimated)
Lead sponsor: Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian FederationOther government
Study start: Sep 2014
Primary completion: Oct 2017 (estimated)
Study completion: Mar 2018 (estimated)
First posted: 5 Aug 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Tissue engineered construction implantation	Experimental	Procedure: Oral mucosa biopsy, Procedure: Sinus lift with implantation of tissue engineered construction, Device: Dental implant

Who may qualify

Ages: 20 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (18 listed)

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

Key exclusion criteria (9 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Oral mucosa biopsy	Procedure or surgery	Tissue engineered construction implantation
Sinus lift with implantation of tissue engineered construction	Procedure or surgery	Tissue engineered construction implantation
Dental implant	Device	Tissue engineered construction implantation

Primary outcome

Number of serious adverse events (SAEs) and serious adverse reactions (SARs)
Time frame: 1 week after treatment

3 secondary outcomes

Quality of life monitoring
Time frame: up to 24 weeks after treatment
Changes in bone tissue volume
Time frame: up to 24 weeks after treatment
Correlation of morphometrical analysis using cone beam CT scan with absolute value of the newly formed bone
Time frame: 24 weeks after treatment

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2016.

Related trials for Partially Edentulous Maxilla

Recruiting
Clinical and Radiographic Evaluation of UV-Treated Dental Implants With or Without Melatonin in the Upper Posterior Jaw
Jaw, Edentulous, Partially, Bone Resorption
Not yet recruitingEarly Phase 1
Radiographic Changes in the Maxillary Sinus Following Closed Sinus Augmentation With Leukocyte Platelet Rich Fibrin
Partially Edentulous Maxilla
Active, not recruiting
Non-Guided vs. Guided Surgery to Immediately Loaded PrimeTaper Implants in Partially Edentulous Patients
Partially Edentulous Maxilla or Mandible
Active, not recruiting
Dimensional Changes in Single Crowns Supported by Short Transmucosal Implants With Diverging or Converging Neck Profiles in the Esthetic Zone
Edentulous Alveolar Ridge
Active, not recruiting
Fully Versus Partially Guided Implants Placement: Measurement of Accuracy of Implant Position and Passivity of Superstructures.
Completely Edentulous, Implant Assesment

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Grigory Volozhin A Volozhin, MD, PhD principal investigator

A.I. Evdokimov Moscow State Medical Stomatological University

Ilya I Eremin, MD, PhD principal investigator

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

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of serious adverse events (SAEs) and serious adverse reactions (SARs) (time frame: 1 week after treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02209311.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2016.