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The Effect of Human Umbilical Cord Mesenchymal Stem Cells and Exosomes on the Healing of Postoperative Pain and Periapical Lesions in the Treatment of Apical Periodontitis: Randomized Controlled Clinical Study

NCT06764004 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2025-01-08

No results posted yet for this study

Summary

The main purpose of this study is to evaluate the effect of Mesenchymal Stem Cells (MSCs) isolated from the umbilical cord and exosomes derived from these cells on the success of the treatment in the regenerative endodontic treatment of necrotic open apex molar teeth.

Regenerative endodontic treatment aims to disinfect root canals and revascularize pulp tissue. Our goals in this study are; obtaining umbilical cord-derived MSCs, obtaining exosomes derived from umbilical cord MSCs, selecting patients with molar teeth with necrotic open apex and periapical lesion, initiation of regenerative endodontic treatment and disinfection of root canals, induction of bleeding in the periapical region and formation of a blood clot in the root canal in the 1st patient group, in the 2nd patient group, umbilical cord-derived MSCs were placed in the root canals without bleeding in the periapical region, in the 3rd patient group, placement of exosomes from umbilical cord-derived MSCs into the root canals without causing bleeding in the periapical region, it is the follow-up of patients at regular intervals for up to 1 year after treatment is completed.

Conditions

  • Apical Periodontitis

Interventions

GENETIC

Stem Cell Product

Human umbilical cord stem cells and exosomes will be used.

BIOLOGICAL

Bleeding and clots

Exosomes obtained from human umbilical cord stem cells will be used

Sponsors & Collaborators

  • TC Erciyes University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
9 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2025-02-01
Completion
2025-05-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06764004 on ClinicalTrials.gov