A Phase 2 interventional study of Gingival mesenchymal stem cell derived small extracellular vesicles and β-calcium triphosphate (β-TCP) + collagen membrane in Infra-bony Periodontal Defect, sponsored by Ain Shams University. Not yet recruiting at 1 site in Egypt. Open to participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Ain Shams University · Phase 2, Interventional, and Treatment
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.
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.
129 studies on the registry are indexed under Periodontal Pocket; 36 are open to participants now.
This study's planned enrollment of 22 is below the median of 30 across 112 interventional studies indexed under Periodontal Pocket.
Browse Periodontal Pocket studies →Ain Shams University is the lead sponsor of 1,930 studies on the registry; 433 are open to participants now.
Of its 33 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Biological: Gingival mesenchymal stem cell derived small extracellular vesicles
Other: β-calcium triphosphate (β-TCP) + collagen membrane
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
in patients with infra-bony periodontal pockets will be received beta tricalcium phosphate scaffold covered by collagen membrane as a control group
bone fill/gain
by paralleling periapical technique, evaluate amount of bone fill
Time frame: 6 months
Clinical Attachment Level Gain
Clinical attachment level will be assessed using periodontal probing
Time frame: 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
Time frame: 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
Time frame: 2 and 4 weeks after the surgical procedure
Plan to share: No
No publications or documents are linked to this record.
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 ↗
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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