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 | Not Yet Recruiting Phase 1

• 1 other identifier: 2025
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Regenerative endodontics, rejeneration, stem cell

Outcome Measures

Primary Outcomes (1)

• Evaluation of patients' postoperative pain with a questionnaire

  It indicates the achievement of outcome measures upon completion of the treatment administered to patients. Pain assessment will be made with the visual analog scale (VAS). A score between 0 and 100 will be given for pain evaluation. '0' indicates no pain, '100' indicates severe pain.

  1-4 months

Secondary Outcomes (1)

• Follow-up of patients with questionnaire their pain and symptoms at regular intervals for up to 1 year

  1-12 mouths

Study Arms (3)

Stem cell group

EXPERIMENTAL

Human umbilical cord stem cells will be used.

Genetic: Stem Cell Product

Exosome group

EXPERIMENTAL

Exosomes obtained from umbilical cord stem cells will be used.

Genetic: Stem Cell Product

Bleeding group

EXPERIMENTAL

A clot will be formed by bleeding in the periapical region of the root canals.

Biological: Bleeding and clots

Interventions

Stem Cell Product GENETIC

Human umbilical cord stem cells and exosomes will be used.

Exosome group; Stem cell group

Bleeding and clots BIOLOGICAL

Exosomes obtained from human umbilical cord stem cells will be used

Bleeding group

Eligibility Criteria

• Age: 9 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Molar teeth with open apex
• Teeth with apical periodontitis
• Teeth for which prosthetic restoration is not planned
• Patients between the ages of 9-15 without any significant health problems
• Patients who are not accompanied by periodontal problems and whose oral hygiene is in good condition

You may not qualify if:

• Individuals with systemic diseases and allergic reactions
• Severely damaged teeth
• Previous root canal treatment has been performed on the tooth.
• Use of antibiotics, anti-inflammatory, and painkillers in the last two weeks
• Teeth with cracks and broken lines

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes University

Melikgazi, Kayseri, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periapical Periodontitis

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Central Study Contacts

İpek ERASLAN AKYÜZ

CONTACT

+9 5385591409; ipekemamak@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dentist

Study Record Dates

• First Submitted: December 22, 2024
• First Posted: January 8, 2025
• Study Start: January 1, 2025
• Primary Completion: February 1, 2025
• Study Completion: May 1, 2025
• Last Updated: January 8, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)