Revitalization of Traumatized Immature Permanent Teeth

Study Overview
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Brief Summary
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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
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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 . 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.

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

Conditions
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Apical Periodontitis, Trauma

Intervention / Treatment
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* Other: revitalization


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| with AP<br> | Other: revitalization<br>* 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 .<br>|
| without AP<br> | Other: revitalization<br>* 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 .<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| radiographic root area (RRA) | RRA post revitalization | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| periapical health | Maintained or restored periapical health post revitalization | 1 year |