Evaluation of Adipose Derived Stem Cells Exo.in Treatment of Periodontitis (exosomes)

February 12, 2020 updated by: Ebtehal Mohammed, Beni-Suef University

Effect of Adipose Derived Stem Cells Exosomes as an Adjunctive Therapy to Scaling and Root Planning in the Treatment of Periodontitis: A Human Clinical Trial

The adipose stem cells exosomes will be extracted from adipose stem cells isolated autogenously from the patient to be injected locally into the periodontal pockets in order to evaluate their regenerative effect.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Early 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 Contact

Study Contact Backup

Study Locations

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

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Advanced periodontitis (Stage III or IV)
  • Healthy patients.

Exclusion Criteria:

  • Smokers, Diabetic, Pregnant ladies, Under corticosteroids or contraceptive treatment,poor oral hygiene.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exosomes
Biological: adipose derived stem cells exosomes
they are small extracellular vesicles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in gingival inflammation
Time Frame: 0, 3 and 6 months
Gingival index (GI)
0, 3 and 6 months
change in pocket depth
Time Frame: 0, 3 and 6 months
Probing depth (PD)
0, 3 and 6 months
change in attachment level
Time Frame: 0, 3 and 6 months
Clinical attachment level (CAL)
0, 3 and 6 months
change in Bone level
Time Frame: 0 and 6 months
Cone beam C.T (CBCT)
0 and 6 months

Collaborators and Investigators

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

Sponsor

Beni-Suef University

Investigators

  • Principal Investigator: Ebtehal Mohammed, Ph.D, Lecturer of Oral Medicine , Oral diagnosis and Periodontology , Faculty of Dentistry, Beni- Suef University.
  • Study Director: Nesrine Mohammed Khairy, Associated Professor, Oral and Maxillofacial Surgery, Faculty of Dentistry, Cairo University
  • Study Director: Noha Saleh Mohammed, Associated, Oral and Maxillofacial Radiology, Faculty of Dentistry, Cairo University.
  • Study Director: Dina Sabry, Professor, Biochemistry, Faculty of Medicine, Cairo University

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)

February 12, 2020

Primary Completion (Anticipated)

September 12, 2020

Study Completion (Anticipated)

October 1, 2021

Study Registration Dates

First Submitted

February 8, 2020

First Submitted That Met QC Criteria

February 12, 2020

First Posted (Actual)

February 17, 2020

Study Record Updates

Last Update Posted (Actual)

February 17, 2020

Last Update Submitted That Met QC Criteria

February 12, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FDBSUREC/21012020/ME

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

the data will be published

IPD Sharing Time Frame

the data will be available after at least one year

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

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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