Treatment of Chronic Medium-severe Periodontitis With Mesenchymal Stem Cells Predifferentiated in Osteogenic Direction

February 8, 2021 updated by: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

Treatment of Chronic Medium-severe Periodontitis With Mesenchymal Stem Cells Predifferentiated in Osteogenic Direction Immobilised on a Biodegradable Carrier

Treatment of chronic medium-severe periodontitis with mesenchymal stem cells and mesenchymal stem cells predifferentiated in osteogenic direction

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The bone defect will be filled with a porous membrane based on bone collagen measuring 5x5 mm or more with mesenchymal stem cells and mesenchymal stem cells predifferentiated in osteogenic direction

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belarus
      • Minsk, Belarus, 220072
        • Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years to 70 years (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

- chronic medium-severe periodontitis

Exclusion Criteria:

  • pregnancy
  • breast-feeding
  • acute and chronic infectious diseases: HIV, viral hepatitis, tuberculosis
  • mental disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: mesenchymal stem cells
standard treatment according to clinical protocols plus mesenchymal stem cells
Biological: mesenchymal stem cells
autologous mesenchymal stem cells
Other: standard treatment
standard treatment according to clinical protocols
ACTIVE_COMPARATOR: standard treatment
standard treatment according to clinical protocols
Other: standard treatment
standard treatment according to clinical protocols

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of patients cured
Time Frame: 1 month
number of patients cured
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

Collaborators

Belarusian Medical Academy of Post-Graduate Education

Investigators

  • Study Director: Sergey Rubnikovich, Prof, Head of the Department of Prosthodontics of BMAPE

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 3, 2020

Primary Completion (ACTUAL)

December 31, 2020

Study Completion (ACTUAL)

December 31, 2020

Study Registration Dates

First Submitted

June 22, 2020

First Submitted That Met QC Criteria

June 22, 2020

First Posted (ACTUAL)

June 25, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 9, 2021

Last Update Submitted That Met QC Criteria

February 8, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IBCE_MSC(periodontitis)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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