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

Periodontitis Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04270006
• Other study ID #: FDBSUREC/21012020/ME
• Status: Recruiting
• Phase: Early Phase 1
• 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
• 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.

Related Conditions & MeSH terms

• Periodontitis

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