Effect of Gingival Mesenchymal Stem Cell-Derived Small Extracellular Vesicles in Management of Infra-bony Periodontal Defect

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age20-40
SponsorAin Shams University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Gingival mesenchymal stem cell derived small extracellular vesicles

    Biological/Vaccine

    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 membrane

    Other intervention

    in patients with infra-bony periodontal pockets will be received beta tricalcium phosphate scaffold covered by collagen membrane as a control group

Treatment groups

22 Participants
are divided into 2 treatment groups
Group A: arm 1 include 11 patientsActive comparator 1 intervention
Group B: arm 2 control group include 11 patientsActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

bone fill/gain

by paralleling periapical technique, evaluate amount of bone fill

Time frame
6 months

Secondary outcomes

1

Clinical Attachment Level Gain

Clinical attachment level will be assessed using periodontal probing

Time frame
6 months
2

Severity Of Adverse Effect

the severity of adverse effects will be assessed using a visual analog scale (VAS)

Time frame
Days 0, 3, 5, and 7 after surgical procedure
3

Local Soft Tissue Healing Score

Local soft tissue healing will be assessed using the healing index (HI)

Time frame
2 and 4 weeks after the surgical procedure

Other outcomes

Sponsors and contacts

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