Clinical trial Recruiting at 1 site Observational Ages 6 to 18

Revitalizing traumatized immature permanent teeth

Official title: Revitalization of Immature Permanent Teeth With or Without Apical Periodontitis Post Trauma: a European Multicenter Cohort Study

Run by Universitaire Ziekenhuizen KU Leuven · NCT06043453 · Data updated 2026-11-12

This study is testing how well revitalization treatments work for young permanent teeth that have been injured, with or without infection, to see if they can heal and develop properly over three years.

Quick facts

Study typeObservational
Ages6 Years to 18 Years
SexAll
Enrollment72 (estimated)
SponsorUniversitaire Ziekenhuizen KU Leuven
Academic / other
Drugs / interventionschemotherapy, radiation
Locations1 site (Ghent)
StatusRecruiting
StartedOctober 1, 2023
Main results expectedSeptember 1, 2028
Study endsSeptember 1, 2030
Registry record updatedJuly 1, 2024
Trial IDNCT06043453 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are children and adolescents aged 6-18 with immature permanent teeth requiring revitalization due to dental trauma.

Probably not a fit

Patients with mature teeth or those who do not meet the specific inclusion criteria, such as older than 18 years or with certain medical histories, may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study investigates the effectiveness of revitalization procedures on immature permanent teeth with and without (a)symptomatic apical periodontitis. It aims to compare outcomes such as root development, periapical bone healing, pulp sensitivity, and tooth survival over a period of up to three years. The study will involve a multicenter approach with blinded assessments for radiographic analysis and statistical evaluation, although operators and patients cannot be blinded due to practical constraints.

Why it matters

Potential benefit: If successful, this study could improve treatment outcomes for children and adolescents with traumatized teeth, enhancing their dental health and quality of life.

How similar studies have gone: Other studies have shown promising results with revitalization techniques in similar patient populations, suggesting potential for success in this approach.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Ghent University
    Ghent, Belgium
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.