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Search / Trial NCT06043453

Revitalization of Traumatized Immature Permanent Teeth

Launched by UNIVERSITAIRE ZIEKENHUIZEN KU LEUVEN · Sep 12, 2023

Trial Information

Current as of November 11, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called revitalization for young teeth that have been injured and are not fully developed. The researchers want to see if this treatment works better for teeth that do not have any symptoms of infection compared to those that do. They are focusing on how well the teeth can grow, heal the surrounding bone, regain feeling, and last over time.

To participate in this study, patients need to be between 6 and 18 years old and have a specific type of immature permanent tooth that requires revitalization due to trauma. They must also be generally healthy, as determined by a medical evaluation. Participants can expect to receive care related to their dental condition and will be monitored throughout the study. It's important to note that certain medical conditions and treatments may exclude someone from joining the trial, as the researchers want to ensure the safety and accuracy of the results.

Gender

ALL

Eligibility criteria

  • 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

About Universitaire Ziekenhuizen Ku Leuven

Universitaire Ziekenhuizen KU Leuven is a leading academic medical center in Belgium, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. Affiliated with KU Leuven, one of Europe’s premier universities, the institution integrates cutting-edge scientific inquiry with high-quality patient care. It plays a pivotal role in the development and implementation of clinical trials, fostering collaboration between researchers, healthcare professionals, and industry partners to translate scientific discoveries into effective treatments. The hospital's multidisciplinary approach ensures comprehensive patient safety and ethical standards, positioning it as a trusted sponsor in the realm of clinical research.

Locations

Ghent, Belgium

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported