Revitalizing traumatized immature permanent teeth
Revitalization of Immature Permanent Teeth With or Without Apical Periodontitis Post Trauma: a European Multicenter Cohort Study
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 type | Observational |
|---|---|
| Enrollment | 72 (estimated) |
| Ages | 6 Years to 18 Years |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Ghent) |
| Trial ID | NCT06043453 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children and adolescents aged 6-18 with immature permanent teeth requiring revitalization due to dental trauma.
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.
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 performed: Other studies have shown promising results with revitalization techniques in similar patient populations, suggesting potential for success in this approach.
Eligibility criteria
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 this trial is running
Ghent
- Ghent University — Ghent, Belgium (Recruiting)
Study contacts
- Study coordinator: Nastaran Meschi, MSc, PhD
- Email: nastaran.meschi@ugent.be
- Phone: +32476313889
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.