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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04270006
Other study ID # FDBSUREC/21012020/ME
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date February 12, 2020
Est. completion date October 2021

Study information

Verified date February 2020
Source Beni-Suef University
Contact Ebtehal Mohammed, Ph.D
Phone 01224336896
Email ebtehalmaawad@dent.bsu.edu.eg,
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 10
Est. completion date October 2021
Est. primary completion date September 12, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Biological:
adipose derived stem cells exosomes
they are small extracellular vesicles

Locations

Country Name City State
Egypt Beni-Suef University Bani Suwayf
Egypt Cairo University Cairo

Sponsors (1)

Lead Sponsor Collaborator
Beni-Suef University

Country where clinical trial is conducted

Egypt, 

Outcome

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