Evaluation of Regenerative Endodontic Treatment for Immature Teeth (NCT07210359) | Clinical Trial Compass
RecruitingNot Applicable
Evaluation of Regenerative Endodontic Treatment for Immature Teeth
Egypt36 participantsStarted 2025-09-15
Plain-language summary
The goal of this clinical trial is to evaluate if regenerative endodontic treatment using two different forms of demineralized dentin matrix (DDM) can effectively treat immature permanent single-rooted teeth compared to treatment using RetroMTA in patients aged 9 to 15 years. The main questions it aims to answer are:
Does the use of DDM improve clinical and radiographic outcomes such as root length, dentinal wall thickness, and apex closure?
Is DDM a viable bioactive alternative to RetroMTA as a coronal sealing material in regenerative endodontic procedures?
Researchers will compare three groups: one using RetroMTA, one using a DDM-TheraCal LC mixture, and one using TDM-Hydrogel, to see if these materials differ in their effects on regenerative outcomes.
Participants will:
Undergo two treatment visits including canal disinfection, induction of bleeding to form a blood clot scaffold,
Receive placement of one of the study materials over the blood clot as a coronal barrier,
Have clinical examinations and CBCT imaging at baseline and multiple follow-ups up to 12 months to assess treatment success through signs, symptoms, and radiographic changes.
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:
* Systemically healthy patients (i.e., free of any systemic diseases).
* Patients presenting with immature permanent single-rooted teeth.
* Age: 9 -15 years.
* Teeth diagnosed as either vital (asymptomatic irreversible pulpitis or symptomatic irreversible pulpitis and the bleeding didn't stop after 5 minutes application of hemostatic agent) or non-vital pulp.
Exclusion Criteria:
* Patients who are allergic to any drugs used in this study or with systemic illness
* Teeth that are grossly decayed or fractured and require post and core as final restorations
* Presence of periodontal pockets greater than 4 mm.
* Radiographical evidence of apical foramen less than 1 mm.
* Presence of periapical radiolucency exceeding 10 mm.
* Presence of external or internal root resorption.
* Patients with a history of major surgeries like cardiac, kidney transplantation, haemodialysis.
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.