The Effect of Human Umbilical Cord Mesenchymal Stem Cells and Exosomes on the Healing of Postoper… (NCT06764004) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
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
Turkey (Türkiye)45 participantsStarted 2025-01-01
Plain-language 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.
Who can participate
Age range
9 Years – 15 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Exclusion criteria
. Individuals with systemic diseases and allergic reactions
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluation of patients' postoperative pain with a questionnaire