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| Name | Class |
|---|---|
| University Ghent | OTHER |
| University of Erlangen-Nürnberg | OTHER |
| University of Regensburg | OTHER |
| University of Coimbra |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| with AP |
| ||
| without AP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| revitalization | Other | 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 . |
| Measure | Description | Time Frame |
|---|---|---|
| radiographic root area (RRA) | RRA post revitalization | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| periapical health | Maintained or restored periapical health post revitalization | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| RRA 2 and 3 years post revitalization | RRA post revitalization | 2 and 3 years |
| Maintained or restored periapical health 2 and 3 years post revitalization (evaluated within each group separately) | periapical health |
Inclusion Criteria:
Exclusion Criteria:
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Healthy patients (ASA I and II), younger than 18 years, presenting an immature permanent tooth in need of treatment, etiological factor: (a)symptomatic apical periodontitis or irreversible pulpitis post dental trauma, no other endodontic treatment option than revitalization possible.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nastaran Meschi, MSc, PhD | Contact | +32476313889 | nastaran.meschi@ugent.be |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ghent University | Recruiting | Ghent | 9000 | Belgium |
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| ID | Term |
|---|---|
| D010485 | Periapical Periodontitis |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D010483 | Periapical Diseases |
| D007571 | Jaw Diseases |
| D009057 | Stomatognathic Diseases |
| D010510 | Periodontal Diseases |
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| ID | Term |
|---|---|
| D000389 | Air Conditioning |
| ID | Term |
|---|---|
| D004780 | Environment, Controlled |
| D004777 | Environment |
| D004778 | Environment and Public Health |
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| OTHER |
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|
| 2 and 3 years |
| Pulp sensitivity 1-3 years post revitalization (evaluated within each group separately due to expected baseline inequivalency between groups) | pulp sensitivity | 1 to 3 years |
| Tooth survival 3 years post revitalization (even if no further root development and incomplete periapical bone healing with no clinical symptoms). | tooth survival | 3 years |
| D009059 |
| Mouth Diseases |
| D010518 | Periodontitis |