PeriodontitisEarly Phase 1exosomesNCT04270006
Evaluation of Adipose Derived Stem Cells Exo.in Treatment of Periodontitis
A Early Phase 1 study testing adipose derived stem cells exosomes in people with Periodontitis, run by Beni-Suef University at 2 sites in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- adipose derived stem cells exosomes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesEgypt
- Study dates
- 12 Feb 2020to Oct 2021
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Advanced periodontitis (Stage III or IV)
- Healthy patients.
Who cannot join
- Smokers, Diabetic, Pregnant ladies, Under corticosteroids or contraceptive treatment,poor oral hygiene.
Trial locations and contacts
2 sites in 1 country.
Noha Saleh, Ph.D contact
Egypt2 sites, 2 recruiting
- Recruiting
Beni-Suef University
Banī Suwayf, 62511
Ebtehal Mohammed, lecturer, 01224336896, ebtehalmaawad@dent.bsu.edu.eg
- Recruiting
Cairo University
Cairo, 11562
Ebtehal Mohammed, 01224336896, ebtehalmaawad@dent.bsu.edu.eg
About this study
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
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.
- Conditions
- Periodontitis
- Being tested
- adipose derived stem cells exosomes
- Keywords
- Periodontitis, SRP, ADSCs, Exosomes, treatment
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adipose derived stem cells exosomesBiological
they are small extracellular vesicles
| Study group | Role | What they receive |
|---|---|---|
| Exosomes | Experimental | Not described Receives: Biological: adipose derived stem cells exosomes |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in gingival inflammation
Gingival index (GI)
Measured: 0, 3 and 6 months
change in pocket depth
Probing depth (PD)
Measured: 0, 3 and 6 months
change in attachment level
Clinical attachment level (CAL)
Measured: 0, 3 and 6 months
change in Bone level
Cone beam C.T (CBCT)
Measured: 0 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start12 Feb 2020
- Primary completion12 Sep 2020 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebtehal Mohammed, Beni-Suef University
- Investigators
- Ebtehal Mohammed, Ph.D, Principal investigator, Lecturer of Oral Medicine , Oral diagnosis and Periodontology , Faculty of Dentistry, Beni- Suef University.Nesrine Mohammed Khairy, Associated Professor, Study director, Oral and Maxillofacial Surgery, Faculty of Dentistry, Cairo UniversityNoha Saleh Mohammed, Associated, Study director, Oral and Maxillofacial Radiology, Faculty of Dentistry, Cairo University.Dina Sabry, Professor, Study director, Biochemistry, Faculty of Medicine, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04270006
- Sponsor's protocol ID
- FDBSUREC/21012020/ME
- Acronym
- exosomes
- Status last verified
- Feb 2020
- First submitted
- 8 Feb 2020
- Last updated
- 17 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: the data will be published
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04270006
- Acronym / sponsor ID
- exosomes / FDBSUREC/21012020/ME
- Conditions
- Periodontitis
- Keywords
- Periodontitis, SRP, ADSCs, Exosomes, treatment
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 12 Feb 2020 (actual)
- Primary completion
- 12 Sep 2020 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 17 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exosomes | Experimental | Biological: adipose derived stem cells exosomes |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Advanced periodontitis (Stage III or IV)
- Healthy patients.
Key exclusion criteria (1 listed)
- Smokers, Diabetic, Pregnant ladies, Under corticosteroids or contraceptive treatment,poor oral hygiene.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| adipose derived stem cells exosomesthey are small extracellular vesicles | Biological | Exosomes |
Primary outcome
change in gingival inflammation
Time frame: 0, 3 and 6 months
Gingival index (GI)
change in pocket depth
Time frame: 0, 3 and 6 months
Probing depth (PD)
change in attachment level
Time frame: 0, 3 and 6 months
Clinical attachment level (CAL)
change in Bone level
Time frame: 0 and 6 months
Cone beam C.T (CBCT)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
- Individual participant dataSharing planned: Yes. the data will be published
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Probiotics Versus Antibiotics as an Adjuvant to Non-surgical Periodontal Treatment Among Smokers With Stage II, Grade B Periodontitis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noha Saleh, Ph.D contact
Ebtehal Mohammed, Ph.D principal investigator
Lecturer of Oral Medicine , Oral diagnosis and Periodontology , Faculty of Dentistry, Beni- Suef University.
Nesrine Mohammed Khairy, Associated Professor study director
Oral and Maxillofacial Surgery, Faculty of Dentistry, Cairo University
Noha Saleh Mohammed, Associated study director
Oral and Maxillofacial Radiology, Faculty of Dentistry, Cairo University.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing adipose derived stem cells exosomes in people with Periodontitis, run by Beni-Suef University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ebtehal Mohammed, Ph.D (01224336896, ebtehalmaawad@dent.bsu.edu.eg,), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in gingival inflammation (time frame: 0, 3 and 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.