Status:
RECRUITING
Revitalization of Traumatized Immature Permanent Teeth
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Collaborating Sponsors:
University Ghent
University of Erlangen-Nürnberg
Conditions:
Apical Periodontitis
Trauma
Eligibility:
All Genders
6-18 years
Brief 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 h...
Detailed Description
1. Trial objectives This study aims to investigate the effectiveness of revitalization procedures, in terms of maintaining or restoring periapical health, further root development and regaining of...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2030
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT06043453
Start Date
October 1 2023
End Date
September 1 2030
Last Update
July 1 2024
Active Locations (1)
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1
Ghent University
Ghent, Belgium, 9000