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

NCT07867067 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: 1675
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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 management of infra-bony periodontal defects over a 6-month follow-up period.

Conditions

Infra-bony Periodontal Defect; Intra-bony Periodontal Defect

Keywords

infra-bony pockets, vertical bone loss, gingival mesenchymal stem cell derived small extracellular vesicles, exosomes

Outcome Measures

Primary Outcomes (1)

• bone fill/gain

  by paralleling periapical technique, evaluate amount of bone fill

  6 months

Secondary Outcomes (3)

• Clinical Attachment Level Gain

  6 months

• Severity Of Adverse Effect

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

• Local Soft Tissue Healing Score

  2 and 4 weeks after the surgical procedure

Study Arms (2)

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

Interventions

Gingival mesenchymal stem cell derived small extracellular vesicles BIOLOGICAL

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

arm 1 include 11 patients

β-calcium triphosphate (β-TCP) + collagen membrane OTHER

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

arm 2 control group include 11 patients

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• (a) Pregnant and lactating females. (b) Non-cooperating patients. Individuals with decision problems (prisoners, disabled, and mentally retarded patients)

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Dentistry Ain Shams University

Cairo, Egypt

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: teaching assistant at periodontology department at BUC University in Cairo

Study Record Dates

• First Submitted: September 23, 2026
• First Posted: October 9, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: October 9, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)