Intra-Bony Defects in Periodontitis PatientsEarly Phase 1NCT07897292
The Efficacy of Exosomes Combined With Synthetic Bone Graft for the Treatment of Periodontal Intra-bony Defects
A Early Phase 1 study testing single flap approach, single flap approach combined with nanocrystalline hydroxyapatite bone substitute and Exosomes in people with Intra-Bony Defects in Periodontitis Patients, run by Khoshoe Al-mokhtar Mohammed at 2 sites in Egypt.
Trial summary
The aim of this study will be to evaluate clinically, radiographically and biochemically the efficacy of exosomes combined with synthetic bone graft for the treatment of periodontal intra-bony defects. Read more about this study
- Who is it for?
- Ages 16 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Intra-Bony Defects in Periodontitis Patients
- What is being tested?
- single flap approach, single flap approach combined with nanocrystalline hydroxyapatite bone substitute and Exosomes
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesEgypt
- Study dates
- 25 Oct 2026to Nov 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 16 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- periodontitis patients to be included in this study should be diagnosed as having stage III periodontitis.
- 2- or 3-wall intra-bony interproximal defect.
- Patient free from any systemic disease that may effect the periodontal status.
Who cannot join
- smokers.
- Pregnant or lactating female patients.
- Patients with unacceptable oral hygiene after the re-evaluation of phase I therapy.
- teeth with Miller grade II or greater mobility, furcation involvement as well as one-wall defects.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt2 sites
Faculty of Dental Medicine, Al-Azhar University (Assiut branch)
Asyut
Khoshoe Al-mokhtar Mohammed, master degree, +201003529976, KhoshoeAl-Mokhtar@dent.aun.edu.eg
Khoshoe Al-mokhtar Mohammed, Master
Faculty of Dentistry, Assiut University
Asyut
Khoshoe Al-mokhtar Mohammed, Master degree, +201003529976, KhoshoeAl-Mokhtar@dent.aun.edu.eg
Khoshoe Al-mokhtar Mohammed, Master
About this study
Official title: The Efficacy of Exosomes Combined With Synthetic Bone Graft in Treatment of Periodontal Intra-Bony Defects in Periodontitis Patients (A Comparative Clinical, Radiographic and Biochemical Study)
The aim of this study will be to evaluate clinically, radiographically and biochemically the efficacy of exosomes combined with synthetic bone graft for the treatment of periodontal intra-bony defects.
- Being tested
- single flap approach, single flap approach combined with nanocrystalline hydroxyapatite bone substitute, Exosomes
- Keywords
- Periodontitis, Intra-Bony Defectst, Treatment, Exosomes, Regeneration
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single flap approachProcedure or surgery
Periodontitis patients with an intra-bony defect will be treated by single flap approach only
single flap approach combined with nanocrystalline hydroxyapatite bone substituteProcedure or surgery
single flap approach combined with nanocrystalline hydroxyapatite bone substitute
ExosomesBiological
Periodontitis patients with an intra-bony defect will be treated by single flap approach combined with exosome and nanocrystalline hydroxyapatite bone substitute
| Study group | Role | What they receive |
|---|---|---|
| Intra-bony defect will be treated by single flap approach. | Active comparator | Periodontitis patients with an intra-bony defect will be treated by single flap approach. Receives: Procedure: single flap approach |
| intra-bony defect will be treated by single flap approach combined with bone substitute | Active comparator | Periodontitis patients with an intra-bony defect will be treated by single flap approach combined with nanocrystalline hydroxyapatite bone substitute Receives: Procedure: single flap approach combined with nanocrystalline hydroxyapatite bone substitute |
| n intra-bony defect will be treated by single flap approach combined with exosome and bone substitu | Experimental | Periodontitis patients with an intra-bony defect will be treated by single flap approach combined with exosome and nanocrystalline hydroxyapatite bone substitute Receives: Biological: Exosomes |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical attachment level (CAL) gain using UNC-15 periodontal probe (University of North Carolina periodontal probe)
change in attachment level in mm using UNC-15 periodontal probe (University of North Carolina periodontal probe)
Measured: baseline, 3, 6, and 9 months after treatment
Marginal bone level (MBL)
change in marginal bone level (MBL) using Cone beam C.T (CBCT)
Measured: baseline, 3, 6, and 9 months after treatment
Secondary outcomes (4)
Gingival index (GI)
change in gingival inflammation. The degree of gingival inflammation will be recorded as follow:
- 0 = Normal gingiva.
- 1 = Mild inflammation, slight change in color, slight edema and no bleeding on probing.
- 2 = Moderate inflammation, redness, edema and bleeding on probing. 33 Patients and methods
- 3= Severe inflammation, marked redness, edema and tendency to spontaneous bleeding.
Measured: baseline, 3, 6, and 9 months after treatment
Modified plaque index (MPI)
plaque accumulation around the gingival margin. The degree of plaque accumulation will be recorded as follow:
- 0= No plaque around the gingival margin.
- 1= A thin film of plaque around the gingival margin. The plaque may be recognized only by running a probe across the tooth surface.
- 2= Moderate accumulation of soft deposits on the gingival margin and/or adjacent tooth surface, which can be seen by the naked eye.
- 3= Abundance plaque accumulation within the gingival pocket and/or on the gingival margin and adjacent tooth surface and hard deposits on the tooth surface are seen.
Measured: baseline, 3, 6, and 9 months after treatment
Probing depth (PD) using UNC-15 periodontal probe (University of North Carolina periodontal probe)
change in pocket depth in mm using UNC-15 periodontal probe (University of North Carolina periodontal probe)
Measured: baseline, 3, 6, and 9 months after treatment
level of BMP-2
Evaluation of the level of BMP-2 in Gingival crevicular fluid (GCF)
Measured: baseline, 1, 4 and 12 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start25 Oct 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intra-Bony Defects in Periodontitis PatientsStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khoshoe Al-mokhtar Mohammed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Khoshoe Al-mokhtar Mohammed, Assiut University
- Investigators
- Ahmed Kassem Mohammed, PhD, Study director, Professor of Oral Medicine, Periodontology, Oral Diagnosis and Dental Radiology Faculty of Dental Medicine Al-Azhar University (Assiut branch)Mahmoud Ali Elsaid, PhD, Study director, Lecturer of Oral Medicine, Periodontology, Oral Diagnosis and Dental Radiology Faculty of Dental Medicine Al-Azhar University (Assiut branch)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07897292
- Sponsor's protocol ID
- AUAREC2025009-6
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Exosomes Combined With Synthetic Bone Graft in Treatment of Periodontal Intra-Bony Defects in Periodontitis Patients (A Comparative Clinical, Radiographic and Biochemical Study)
- ClinicalTrials.gov ID
- NCT07897292
- Acronym / sponsor ID
- AUAREC2025009-6
- Keywords
- Periodontitis, Intra-Bony Defectst, Treatment, Exosomes, Regeneration
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Khoshoe Al-mokhtar MohammedUniversity, hospital or other
- Study start
- 25 Oct 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 27 Oct 2026 (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 aim of this study will be to evaluate clinically, radiographically and biochemically the efficacy of exosomes combined with synthetic bone graft for the treatment of periodontal intra-bony defects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intra-bony defect will be treated by single flap approach. | Active comparator | Procedure: single flap approachPeriodontitis patients with an intra-bony defect will be treated by single flap approach. |
| intra-bony defect will be treated by single flap approach combined with bone substitute | Active comparator | Procedure: single flap approach combined with nanocrystalline hydroxyapatite bone substitutePeriodontitis patients with an intra-bony defect will be treated by single flap approach combined with nanocrystalline hydroxyapatite bone substitute |
| n intra-bony defect will be treated by single flap approach combined with exosome and bone substitu | Experimental | Biological: ExosomesPeriodontitis patients with an intra-bony defect will be treated by single flap approach combined with exosome and nanocrystalline hydroxyapatite bone substitute |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- periodontitis patients to be included in this study should be diagnosed as having stage III periodontitis.
- 2- or 3-wall intra-bony interproximal defect.
- Patient free from any systemic disease that may effect the periodontal status.
Key exclusion criteria (4 listed)
- smokers.
- Pregnant or lactating female patients.
- Patients with unacceptable oral hygiene after the re-evaluation of phase I therapy.
- teeth with Miller grade II or greater mobility, furcation involvement as well as one-wall defects.
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 |
|---|---|---|
| single flap approachPeriodontitis patients with an intra-bony defect will be treated by single flap approach only | Procedure or surgery | Intra-bony defect will be treated by single flap approach. |
| single flap approach combined with nanocrystalline hydroxyapatite bone substitutesingle flap approach combined with nanocrystalline hydroxyapatite bone substitute | Procedure or surgery | intra-bony defect will be treated by single flap approach combined with bone substitute |
| ExosomesPeriodontitis patients with an intra-bony defect will be treated by single flap approach combined with exosome and nanocrystalline hydroxyapatite bone substitute | Biological | n intra-bony defect will be treated by single flap approach combined with exosome and bone substitu |
Primary outcome
clinical attachment level (CAL) gain using UNC-15 periodontal probe (University of North Carolina periodontal probe)
Time frame: baseline, 3, 6, and 9 months after treatment
change in attachment level in mm using UNC-15 periodontal probe (University of North Carolina periodontal probe)
Marginal bone level (MBL)
Time frame: baseline, 3, 6, and 9 months after treatment
change in marginal bone level (MBL) using Cone beam C.T (CBCT)
4 secondary outcomes
Gingival index (GI)
Time frame: baseline, 3, 6, and 9 months after treatment
Modified plaque index (MPI)
Time frame: baseline, 3, 6, and 9 months after treatment
Probing depth (PD) using UNC-15 periodontal probe (University of North Carolina periodontal probe)
Time frame: baseline, 3, 6, and 9 months after treatment
level of BMP-2
Time frame: baseline, 1, 4 and 12 weeks after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: Yes. Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report
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.
Ahmed Kassem Mohammed, PhD study director
Professor of Oral Medicine, Periodontology, Oral Diagnosis and Dental Radiology Faculty of Dental Medicine Al-Azhar University (Assiut branch)
Mahmoud Ali Elsaid, PhD study director
Lecturer of Oral Medicine, Periodontology, Oral Diagnosis and Dental Radiology Faculty of Dental Medicine Al-Azhar University (Assiut branch)
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 single flap approach, single flap approach combined with nanocrystalline hydroxyapatite bone substitute and Exosomes in people with Intra-Bony Defects in Periodontitis Patients, run by Khoshoe Al-mokhtar Mohammed 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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 27 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Khoshoe Al-mokhtar Mohammed, master degree (+201003529976, KhoshoeAl-Mokhtar@dent.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical attachment level (CAL) gain using UNC-15 periodontal probe (University of North Carolina periodontal probe) (time frame: baseline, 3, 6, and 9 months after treatment). The study lists 2 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 27 Oct 2026.