Revitalization of Traumatized Immature Permanent Teeth
Belgium72 participantsStarted 2023-10-01
Plain-language summary
This study aims to assess the hypothesis that revitalization of teeth without (a)symptomatic apical periodontitis have a more favourable outcome in terms of further root development, periapical bone healing, maintaining/regaining pulp sensitivity and survival, than teeth with (a)symptomatic apical periodontitis.
Who can participate
Age range
6 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:
* Provision of Informed Consent
* Female and male patients
* Age range: 6-18 years
* "Healthy": ASA I and II
* Permanent immature tooth (Cvek stage of root maturation ≤ 2) requiring revitalization
* Etiological factor: (a)symptomatic apical periodontitis post dental trauma or irreversible pulpitis post dental trauma
Exclusion Criteria:
* Unlikely to be able to comply with the study procedures, as judged by the investigator
* Patients older than 18 years and younger than 6
* Deciduous teeth
* Cvek root maturation stage \> 2: permanent immature tooth that can be treated by conventional root canal treatment or apexification
* Known or suspected current malignancy
* History of chemotherapy within 5 years prior to study
* History of radiation in the head and neck region
* History of other metabolic bone diseases
* Bleeding disorders
* Involvement in the planning and conduct of the study
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.