NCT06043453

Revitalization of Traumatized Immature Permanent Teeth

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 72 (estimated)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: 6 Years – 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Apical Periodontitis
• Trauma

Interventions

Type	Name	Description
OTHER	revitalization	The main idea behind revitalization is to firstly disinfect the root canal and subsequently attract or transplant mesenchymal stem cells from the (remaining) dental pulp and apical papilla (in case of immature permanent teeth) into the root canal. More specifically, this therapy is not based on mechanical and (aggressive) chemical debridement as in conventional root canal treatment but is supported by the pillars of tissue engineering: stem cells, growth factors and a scaffold .

Timeline

• Start date: 2023-10-01
• Primary completion: 2028-09-01
• Completion: 2030-09-01
• First posted: 2023-09-21
• Last updated: 2024-07-01

Locations

1 site across 1 country: Belgium