Evaluation of Adipose Derived Stem Cells Exo.in Treatment of Periodontitis
exosomes
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
1 other identifier
interventional
10
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for early_phase_1
Started Feb 2020
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 8, 2020
CompletedStudy Start
First participant enrolled
February 12, 2020
CompletedFirst Posted
Study publicly available on registry
February 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 12, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2021
CompletedFebruary 17, 2020
February 1, 2020
7 months
February 8, 2020
February 12, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
change in gingival inflammation
Gingival index (GI)
0, 3 and 6 months
change in pocket depth
Probing depth (PD)
0, 3 and 6 months
change in attachment level
Clinical attachment level (CAL)
0, 3 and 6 months
change in Bone level
Cone beam C.T (CBCT)
0 and 6 months
Study Arms (1)
Exosomes
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Advanced periodontitis (Stage III or IV)
- Healthy patients.
You may not qualify if:
- Smokers, Diabetic, Pregnant ladies, Under corticosteroids or contraceptive treatment,poor oral hygiene.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Beni-Suef University
Banī Suwayf, 62511, Egypt
Cairo University
Cairo, 11562, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of oral medicine, periodontotlogy and oral diagnosis
Study Record Dates
First Submitted
February 8, 2020
First Posted
February 17, 2020
Study Start
February 12, 2020
Primary Completion
September 12, 2020
Study Completion
October 1, 2021
Last Updated
February 17, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- the data will be available after at least one year
the data will be published