Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
72 participants
OBSERVATIONAL
2023-10-01
2030-09-01
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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with AP
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 .
without AP
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 .
Interventions
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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 .
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
6 Years
18 Years
ALL
Yes
Sponsors
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University Ghent
OTHER
University of Erlangen-Nürnberg
OTHER
University of Regensburg
OTHER
University of Coimbra
OTHER
Universitaire Ziekenhuizen KU Leuven
OTHER
Responsible Party
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Locations
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Ghent University
Ghent, , Belgium
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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S67181
Identifier Type: -
Identifier Source: org_study_id
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