Encapsulated Acellular System From Mesenchymal Stem Cells for Dental Pulp Regeneration (NCT05599087) | Clinical Trial Compass
UnknownPhase 1
Encapsulated Acellular System From Mesenchymal Stem Cells for Dental Pulp Regeneration
Chile10 participantsStarted 2022-12-30
Plain-language summary
To evaluate the security and efficacy in the administration of encapsulated acellular system derived from Mesenchymal Stem Cells as a novel regenerative endodontic procedure which to promote the pulpar regenration.
Who can participate
Age range
18 Years – 65 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:
* Systemically healthy patients (ASA I).
* Patient presenting with a maxillary or mandibular incisor/canine and mandibular premolar with mature apex, pulpal necrosis, and apical radiographic evidence of apical periodontitis (PAI ≥2 and CBCTPAI ≥1).
* Patient presents with a tooth that does not respond to electrical and thermal pulp testing.
* Patients with restorable teeth (considering the definition of class A or B, according to Samet and Jotkowitz classification) without the need for a single fine prosthesis (crown) or major restoration.
Exclusion Criteria:
* Patients not available for the follow-up period (27 weeks).
* Patients who will undergo orthodontic treatment in the next six months.
* Patients with reports of allergies to any material or medication used in the study.
* Pregnant patients.
* Heavy smokers (more than 10 cigarettes per day).
* Patients with a history of systemic diseases that impair immune function, such as diabetes mellitus, immunodeficiency, leukemia, Addison's and Cushing's disease.
* Patients who have used immunosuppressive drugs or chemotherapy, 3 months before the study. Or that they will be irradiated or undergo chemotherapy.
* Patients who have endodontically treated teeth.
* Patients who have teeth with signs of severe root resorption.
* Patients who have teeth with mobility class III or Dens invaginatus.
* Patients who have teeth with a history of avulsion-type dentoalveolar trauma.
* Patients who have teeth with clinica…
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.