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

Primary Purpose

Periodontitis

Status
Unknown status
Phase
Early Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
adipose derived stem cells exosomes
Sponsored by
Beni-Suef University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis focused on measuring Periodontitis, SRP, ADSCs, Exosomes, treatment

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Beni-Suef UniversityRecruiting
  • Cairo UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Exosomes

Arm Description

Outcomes

Primary Outcome Measures

change in gingival inflammation
Gingival index (GI)
change in pocket depth
Probing depth (PD)
change in attachment level
Clinical attachment level (CAL)
change in Bone level
Cone beam C.T (CBCT)

Secondary Outcome Measures

Full Information

First Posted
February 8, 2020
Last Updated
February 12, 2020
Sponsor
Beni-Suef University
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1. Study Identification

Unique Protocol Identification Number
NCT04270006
Brief Title
Evaluation of Adipose Derived Stem Cells Exo.in Treatment of Periodontitis
Acronym
exosomes
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 12, 2020 (Actual)
Primary Completion Date
September 12, 2020 (Anticipated)
Study Completion Date
October 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beni-Suef University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis
Keywords
Periodontitis, SRP, ADSCs, Exosomes, treatment

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Exosomes
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
adipose derived stem cells exosomes
Intervention Description
they are small extracellular vesicles
Primary Outcome Measure Information:
Title
change in gingival inflammation
Description
Gingival index (GI)
Time Frame
0, 3 and 6 months
Title
change in pocket depth
Description
Probing depth (PD)
Time Frame
0, 3 and 6 months
Title
change in attachment level
Description
Clinical attachment level (CAL)
Time Frame
0, 3 and 6 months
Title
change in Bone level
Description
Cone beam C.T (CBCT)
Time Frame
0 and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Advanced periodontitis (Stage III or IV) Healthy patients. Exclusion Criteria: Smokers, Diabetic, Pregnant ladies, Under corticosteroids or contraceptive treatment,poor oral hygiene.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ebtehal Mohammed, Ph.D
Phone
01224336896
Email
ebtehalmaawad@dent.bsu.edu.eg,
First Name & Middle Initial & Last Name or Official Title & Degree
Noha Saleh, Ph.D
Email
noha.saleh@dentistry.cu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ebtehal Mohammed, Ph.D
Organizational Affiliation
Lecturer of Oral Medicine , Oral diagnosis and Periodontology , Faculty of Dentistry, Beni- Suef University.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nesrine Mohammed Khairy, Associated Professor
Organizational Affiliation
Oral and Maxillofacial Surgery, Faculty of Dentistry, Cairo University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Noha Saleh Mohammed, Associated
Organizational Affiliation
Oral and Maxillofacial Radiology, Faculty of Dentistry, Cairo University.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Dina Sabry, Professor
Organizational Affiliation
Biochemistry, Faculty of Medicine, Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
Beni-Suef University
City
Banī Suwayf
ZIP/Postal Code
62511
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ebtehal Mohammed, lecturer
Phone
01224336896
Email
ebtehalmaawad@dent.bsu.edu.eg
Facility Name
Cairo University
City
Cairo
ZIP/Postal Code
11562
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ebtehal Mohammed
Phone
01224336896
Email
ebtehalmaawad@dent.bsu.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
the data will be published
IPD Sharing Time Frame
the data will be available after at least one year

Learn more about this trial

Evaluation of Adipose Derived Stem Cells Exo.in Treatment of Periodontitis

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