Apical Periodontitis, Trauma
Conditions
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.
Interventions
OTHERrevitalization
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 .
Sponsors
University Ghent
University of Erlangen-Nürnberg
University of Regensburg
University of Coimbra
Universitaire Ziekenhuizen KU Leuven
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| radiographic root area (RRA) | 1 year | RRA post revitalization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| periapical health | 1 year | Maintained or restored periapical health post revitalization |
Other
| Measure | Time frame | Description |
|---|---|---|
| Maintained or restored periapical health 2 and 3 years post revitalization (evaluated within each group separately) | 2 and 3 years | periapical health |
| Pulp sensitivity 1-3 years post revitalization (evaluated within each group separately due to expected baseline inequivalency between groups) | 1 to 3 years | pulp sensitivity |
| Tooth survival 3 years post revitalization (even if no further root development and incomplete periapical bone healing with no clinical symptoms). | 3 years | tooth survival |
| RRA 2 and 3 years post revitalization | 2 and 3 years | RRA post revitalization |
Countries
Belgium
Contacts
Primary ContactNastaran Meschi, MSc, PhD
Outcome results
None listed