Endodontic Regenerative Procedure for Immature Non-vital Teeth
Stopped: The study was not started due to the lack of funding.
United States0Started 2019-06
Plain-language summary
In this clinical trial the investigators will evaluate an alternate treatment option, which was developed for teeth with incomplete roots, called Regenerative Endodontic Procedure (REP). This treatment works by harnessing the blood clot formed within the root canal from tissues surrounding the root as a scaffold for stem cells. These cells could help to increase the thickness and length of the root canal walls resulting in root end maturation.
Results from the 50 participants who will receive the REP treatment will be compared with findings with historical data.
Who can participate
Age range
7 Years – 18 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:
Subjects followed prospectively
* 7-18 years old
* salvageable permanent non-vital tooth with immature apex whether anterior or posterior
* receiving dental care at the Henry M. Goldman School of Dentistry Historical controls
* 7-18 year old
* salvageable permanent non-vital tooth with immature apex whether anterior or posterior
* received care and has accessible records at the Henry M. Goldman School of Dentistry
* had either the Calcium hydroxide apexification or MTA apexification between 2007 and 2017
Exclusion Criteria:
* allergic to medications necessary to complete procedure
* health status not in: a) ASA-1 no organic pathology or patients in whom the pathological process is localized and does not cause any systemic disturbance or abnormality; nor b) ASA 2 A moderate but definite systemic disturbance, caused either by the condition that is to be treated or surgical intervention or which is caused by other existing pathological processes
* history of dental trauma within 6 months due to possibility of internal and external root resorption.
* if tooth pulp space is needed for post/core final restoration
* pregnancy in female subjects
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.