Revitalization of Traumatized Immature Permanent Teeth

Recruiting

• Conditions: Apical Periodontitis; Trauma
• Interventions: Other: revitalization

• Registration Number: NCT06043453
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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 healing, maintaining/regaining pulp sensitivity and survival, than teeth with (a)symptomatic apical periodontitis.

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 pulp sensitivity, in immature permanent teeth with (group 1) or without (group 2) (a)symptomatic apical periodontitis .

2. Primary endpoints RRA at 1 year post revitalization. 3 Secondary endpoints Maintained or restored periapical health (evaluated within each group separately due to expected baseline inequivalency between groups) 1 year post revitalization.

4 Other endpoints

* RRA 2 and 3 years post revitalization

* Maintained or restored periapical health 2 and 3 years post revitalization (evaluated within each group separately)

* Pulp sensitivity 1-3 years post revitalization (evaluated within each group separately due to expected baseline inequivalency between groups)

* Tooth survival 3 years post revitalization (even if no further root development and incomplete periapical bone healing with no clinical symptoms).

5 Trial Design Open, prospective cohort, multicenter Blinded: radiographic assessment and statistical analysis; operators and patients cannot be blinded, due to practically not feasible.

Study Timeline

• Status Verified: 2023-08
• Study First Submitted: 2023-09-12
• Study First Submitted QC: 2023-09-12
• Study First Posted: 2023-09-21
• Study Start: 2023-10-01
• Last Update Submitted: 2024-06-28
• Last Update Posted: 2024-07-01
• Primary Completion: 2028-09-01
• Study Completion: 2030-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
with AP	revitalization	-
without AP	revitalization	-

Primary Outcome Measures

Name	Time	Method
radiographic root area (RRA)	1 year	RRA post revitalization

Secondary Outcome Measures

Name	Time	Method
periapical health	1 year	Maintained or restored periapical health post revitalization

Trial Locations

Locations (1)

Ghent University; 🇧🇪 Ghent, Belgium