Infra-bony Periodontal DefectPhase 2NCT07867067
Effect of Gingival Mesenchymal Stem Cell-Derived Small Extracellular Vesicles in Management of Infra-bony Periodontal Defect
A Phase 2 study testing Gingival mesenchymal stem cell derived small extracellular vesicles and β-calcium triphosphate (β-TCP) + collagen membrane in people with Infra-bony Periodontal Defect, run by Ain Shams University at 1 site in Egypt.
Trial summary
The goal of the study to evaluate whether the adjunctive use of gingival mesenchymal stem cell-derived extracellular vesicles (GMSC-derived EVs) combined with β-tricalcium phosphate (β-TCP) and a collagen membrane results in superior radiographic bone fill compared to β-TCP and collagen membrane alone in the surgical… Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Infra-bony Periodontal Defect
- What is being tested?
- Gingival mesenchymal stem cell derived small extracellular vesicles and β-calcium triphosphate (β-TCP) + collagen membrane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2026to 1 Nov 2027
- Phase
- Phase 2
- 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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Healthy Individuals
- Non-smokers
- Presence of interproximal defect in the bone wall of two or three osseous estimated by periapical radiographic evaluation and probing depth ≥6 mm after S1 and S2 therapy
- Loss of clinical attachment ≥4 mm after S1 and S2 treatment
- Full mouth plaque score and bleeding on probing score ≤20% after S1 and S2 therapy
- Only vital teeth involved
- Thick gingival biotype more than 1 mm with enough width of attached gingiva.
Who cannot join
- Pregnant and lactating females.
- Non-cooperating patients. Individuals with decision problems (prisoners, disabled, and mentally retarded patients)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Faculty of Dentistry Ain Shams University
Cairo
Manar R Mehanny, BDS, 01110367866, manar27ramadan@gmail.com
About this study
Official title: Adjunctive Use of Gingival Mesenchymal Stem Cell-Derived Small Extracellular Vesicles in Management of Infra-bony Periodontal Defects: A Randomized Controlled Clinical Trial
The goal of the study to evaluate whether the adjunctive use of gingival mesenchymal stem cell-derived extracellular vesicles (GMSC-derived EVs) combined with β-tricalcium phosphate (β-TCP) and a collagen membrane results in superior radiographic bone fill compared to β-TCP and collagen membrane alone in the surgical management of infra-bony periodontal defects over a 6-month follow-up period.
Read the detailed description
Patients are diagnosed as periodontitis Stage ( III,IV) Grade (A,B,C) with infra-bony periodontal defect in the bone wall of two or three osseous wall estimated by radiographic evaluation and patients not responding to S1 and S2 there is residual pockets ≥4 mm with bleeding on probing or presence of deep periodontal pockets ≥6 mm, full mouth plaque score and bleeding on probing score ≤ 20% , only vital teeth involved, thick gingival biotype more than 1 mm with enough width of attached gingiva
According to S3 EFP guidelines S1 and S2 done with Supra-gingival dental biofilm control, improving the effectiveness of oral hygiene, the selected patients will be assigned to complete full mouth non-surgical periodontal treatment, which include supra-gingival scaling, subgingival root planning and curettage with ultrasonic instruments and manual instrumentation with Gracey curettes, with using adjunctive local antibiotics .Patients will be advised to perform regular oral hygiene and to use mouthwash with chlorhexidine twice a day for a week. The patients will be reminded every 2 days and informed of the appropriate instructions for the complete mechanical control of the plaque, which consisted of brushing with a soft toothbrush with a roller technique and cleaning interdentally with dental floss. Supra-gingival plaque removal will be performed when necessary.
After 4-6 weeks, patients will be re-examined to ensure indication of periodontal surgery after initial therapy.
Patients who refer to S3 divided into subgroups:
Group I: 11 patients with infra-bony periodontal defects will receive beta -tricalcium phosphate (β-TCP) scaffold followed by collagen membrane coverage Group II: 11 patients with infra-bony periodontal defects will receive gingival mesenchymal stem cells derived small extracellular vesicles on the β-TCP scaffold and covered by a collagen membrane.
- Conditions
- Infra-bony Periodontal Defect
- Being tested
- Gingival mesenchymal stem cell derived small extracellular vesicles, β-calcium triphosphate (β-TCP) + collagen membrane
- Keywords
- infra-bony pockets, vertical bone loss, periodontal pocket, gingival mesenchymal stem cell derived small extracellular vesicles, gingival mesenchymal stem cell derived exosomes, exosomes
- Medical subject headings
- Periodontal Pocket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gingival mesenchymal stem cell derived small extracellular vesiclesBiological
gingival sample will be taken from the patient and cultured for small extracellular vesicles extraction and then will be carried on a B-TCP scaffold covered by collagen membrane inserted into infra-bony periodontal defect in the same patient for arm group 1
β-calcium triphosphate (β-TCP) + collagen membraneOther
in patients with infra-bony periodontal pockets will be received beta tricalcium phosphate scaffold covered by collagen membrane as a control group
| Study group | Role | What they receive |
|---|---|---|
| arm 1 include 11 patients | Active comparator | Not described Receives: Biological: Gingival mesenchymal stem cell derived small extracellular vesicles |
| arm 2 control group include 11 patients | Active comparator | Not described Receives: Other: β-calcium triphosphate (β-TCP) + collagen membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
bone fill/gain
by paralleling periapical technique, evaluate amount of bone fill
Measured: 6 months
Secondary outcomes (3)
Clinical Attachment Level Gain
Clinical attachment level will be assessed using periodontal probing
Measured: 6 months
Severity Of Adverse Effects as measured by visual analog scale
the visual analog scale (VAS) will be used to assess the severity of adverse effects following the surgical procedure. A score of 0 indicated an absence of pain/bleeding/swelling/bruising and 10 designated severe pain/bleeding/swelling/bruising
Measured: Days 0, 3, 5, and 7 after surgical procedure
Local Soft Tissue Healing Score
Local soft tissue healing will be assessed using the healing index (HI). Score 1, very poor (with presence of 2 or more signs) ,Score 2: poor healing ,Score 3: Good healing, Score 4: Very good healing , Score 5: Excellent healing
Measured: 2 and 4 weeks after the surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infra-bony Periodontal DefectStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manar Ramadan, Badr University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07867067
- Sponsor's protocol ID
- 1675
- Status last verified
- Oct 2026
- First submitted
- 23 Sep 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunctive Use of Gingival Mesenchymal Stem Cell-Derived Small Extracellular Vesicles in Management of Infra-bony Periodontal Defects: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07867067
- Acronym / sponsor ID
- 1675
- Conditions
- Infra-bony Periodontal Defect
- Keywords
- infra-bony pockets, vertical bone loss, periodontal pocket, gingival mesenchymal stem cell derived small extracellular vesicles, gingival mesenchymal stem cell derived exosomes, exosomes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 9 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 goal of the study to evaluate whether the adjunctive use of gingival mesenchymal stem cell-derived extracellular vesicles (GMSC-derived EVs) combined with β-tricalcium phosphate (β-TCP) and a collagen membrane results in superior radiographic bone fill compared to β-TCP and collagen membrane alone in the surgical management of infra-bony periodontal defects over a 6-month follow-up period.
Detailed description
Patients are diagnosed as periodontitis Stage ( III,IV) Grade (A,B,C) with infra-bony periodontal defect in the bone wall of two or three osseous wall estimated by radiographic evaluation and patients not responding to S1 and S2 there is residual pockets ≥4 mm with bleeding on probing or presence of deep periodontal pockets ≥6 mm, full mouth plaque score and bleeding on probing score ≤ 20% , only vital teeth involved, thick gingival biotype more than 1 mm with enough width of attached gingiva
According to S3 EFP guidelines S1 and S2 done with Supra-gingival dental biofilm control, improving the effectiveness of oral hygiene, the selected patients will be assigned to complete full mouth non-surgical periodontal treatment, which include supra-gingival scaling, subgingival root planning and curettage with ultrasonic instruments and manual instrumentation with Gracey curettes, with using adjunctive local antibiotics .Patients will be advised to perform regular oral hygiene and to use mouthwash with chlorhexidine twice a day for a week. The patients will be reminded every 2 days and informed of the appropriate instructions for the complete mechanical control of the plaque, which consisted of brushing with a soft toothbrush with a roller technique and cleaning interdentally with dental floss. Supra-gingival plaque removal will be performed when necessary.
After 4-6 weeks, patients will be re-examined to ensure indication of periodontal surgery after initial therapy.
Patients who refer to S3 divided into subgroups:
Group I: 11 patients with infra-bony periodontal defects will receive beta -tricalcium phosphate (β-TCP) scaffold followed by collagen membrane coverage Group II: 11 patients with infra-bony periodontal defects will receive gingival mesenchymal stem cells derived small extracellular vesicles on the β-TCP scaffold and covered by a collagen membrane.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| arm 1 include 11 patients | Active comparator | Biological: Gingival mesenchymal stem cell derived small extracellular vesicles |
| arm 2 control group include 11 patients | Active comparator | Other: β-calcium triphosphate (β-TCP) + collagen membrane |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy Individuals
- Non-smokers
- Presence of interproximal defect in the bone wall of two or three osseous estimated by periapical radiographic evaluation and probing depth ≥6 mm after S1 and S2 therapy
- Loss of clinical attachment ≥4 mm after S1 and S2 treatment
- Full mouth plaque score and bleeding on probing score ≤20% after S1 and S2 therapy
Key exclusion criteria (2 listed)
- Pregnant and lactating females.
- Non-cooperating patients. Individuals with decision problems (prisoners, disabled, and mentally retarded patients)
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 |
|---|---|---|
| Gingival mesenchymal stem cell derived small extracellular vesiclesgingival sample will be taken from the patient and cultured for small extracellular vesicles extraction and then will be carried on a B-TCP scaffold covered by collagen membrane inserted into infra-bony periodontal defect in the same patient for arm group 1 | Biological | arm 1 include 11 patients |
| β-calcium triphosphate (β-TCP) + collagen membranein patients with infra-bony periodontal pockets will be received beta tricalcium phosphate scaffold covered by collagen membrane as a control group | Other | arm 2 control group include 11 patients |
Primary outcome
bone fill/gain
Time frame: 6 months
by paralleling periapical technique, evaluate amount of bone fill
3 secondary outcomes
Clinical Attachment Level Gain
Time frame: 6 months
Severity Of Adverse Effects as measured by visual analog scale
Time frame: Days 0, 3, 5, and 7 after surgical procedure
Local Soft Tissue Healing Score
Time frame: 2 and 4 weeks after the surgical procedure
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 15 Oct 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gingival mesenchymal stem cell derived small extracellular vesicles and β-calcium triphosphate (β-TCP) + collagen membrane in people with Infra-bony Periodontal Defect, run by Ain Shams University at 1 site 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 7 inclusion and 2 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 15 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 1 site 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bone fill/gain (time frame: 6 months). 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 15 Oct 2026.