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Not yet recruitingNCT07897292Updated Oct 27, 2026

The Efficacy of Exosomes Combined With Synthetic Bone Graft for the Treatment of Periodontal Intra-bony Defects

An Early Phase 1 interventional study of single flap approach and single flap approach combined with nanocrystalline hydroxyapatite bone substitute in Intra-Bony Defects in Periodontitis Patients, sponsored by Khoshoe Al-mokhtar Mohammed. Not yet recruiting at 2 sites in Egypt. Open to participants aged 16 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-27.

Sponsored by Khoshoe Al-mokhtar Mohammed · Early Phase 1, Interventional, and Treatment

Updated Oct 27, 2026Newly registeredGo to Updates ↓
Phase
Early Phase 1
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
16 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Intra-Bony Defects in Periodontitis Patients

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Keywords

  • Periodontitis
  • Intra-Bony Defectst
  • Treatment
  • Exosomes
  • Regeneration
03

In context

Periodontitis

1,231 studies on the registry are indexed under Periodontitis; 295 are open to participants now.

This study's planned enrollment of 30 is below the median of 44 across 846 interventional studies indexed under Periodontitis.

Browse Periodontitis studies →

Lead sponsor

This is the only study on the registry with Khoshoe Al-mokhtar Mohammed as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Active comparator
    Intra-bony defect will be treated by single flap approach.

    Periodontitis patients with an intra-bony defect will be treated by single flap approach.

    Procedure: single flap approach

  • Active comparator
    intra-bony defect will be treated by single flap approach combined with bone substitute

    Periodontitis patients with an intra-bony defect will be treated by single flap approach combined with nanocrystalline hydroxyapatite bone substitute

    Procedure: single flap approach combined with nanocrystalline hydroxyapatite bone substitute

  • Experimental
    n intra-bony defect will be treated by single flap approach combined with exosome and bone substitu

    Periodontitis patients with an intra-bony defect will be treated by single flap approach combined with exosome and nanocrystalline hydroxyapatite bone substitute

    Biological: Exosomes

Interventions

  • Proceduresingle flap approach

    Periodontitis patients with an intra-bony defect will be treated by single flap approach only

  • Proceduresingle flap approach combined with nanocrystalline hydroxyapatite bone substitute

    single flap approach combined with nanocrystalline hydroxyapatite bone substitute

  • BiologicalExosomes

    Periodontitis patients with an intra-bony defect will be treated by single flap approach combined with exosome and nanocrystalline hydroxyapatite bone substitute

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: baseline, 3, 6, and 9 months after treatment

  2. Marginal bone level (MBL)

    change in marginal bone level (MBL) using Cone beam C.T (CBCT)

    Time frame: baseline, 3, 6, and 9 months after treatment

Secondary outcomes

  1. 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.

    Time frame: baseline, 3, 6, and 9 months after treatment

  2. 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.

    Time frame: baseline, 3, 6, and 9 months after treatment

  3. 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)

    Time frame: baseline, 3, 6, and 9 months after treatment

  4. level of BMP-2

    Evaluation of the level of BMP-2 in Gingival crevicular fluid (GCF)

    Time frame: baseline, 1, 4 and 12 weeks after surgery

07

Study locations

2 sites
08

References and documents

Individual participant data

Plan to share: Yes — Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Aug 2027, 10 months later.

Of 27 phase 1 interventional studies under Periodontitis, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 19. This study's planned 10 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 14, 2026
First posted
Oct 27, 2026
StartEst.
Oct 25, 2026
Primary completionEst.
Aug 2027
CompletionEst.
Nov 2027
Last update
Oct 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 27, 2026
Show all 1 update
  1. Oct 27, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07897292
Lead sponsor
Khoshoe Al-mokhtar Mohammed
Responsible party
Khoshoe Al-mokhtar Mohammed (assistant lecturer, Assiut University) — Sponsor-investigator
First posted
Oct 27, 2026
Start date
Oct 25, 2026 (estimated)
Primary completion
Aug 2027 (estimated)
Completion
Nov 2027 (estimated)
Last update
Oct 27, 2026

Study contacts

Khoshoe Al-mokhtar Mohammed, master degree
Contact
KhoshoeAl-Mokhtar@dent.aun.edu.eg
+201003529976
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)

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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