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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Gingival mesenchymal stem cell derived small extracellular vesicles
Biological/Vaccinegingival 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 interventionin patients with infra-bony periodontal pockets will be received beta tricalcium phosphate scaffold covered by collagen membrane as a control group
Treatment groups
Trial outcomes
Primary outcomes
bone fill/gain
by paralleling periapical technique, evaluate amount of bone fill
Secondary outcomes
Clinical Attachment Level Gain
Clinical attachment level will be assessed using periodontal probing
Severity Of Adverse Effect
the severity of adverse effects will be assessed using a visual analog scale (VAS)
Local Soft Tissue Healing Score
Local soft tissue healing will be assessed using the healing index (HI)
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: