Revitalization of Traumatized Immature Permanent Teeth

ConditionsApical Periodontitis Trauma

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age6-18

SponsorUniversitaire Ziekenhuizen KU Leuven

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Provision of Informed Consent

Female and male patients

Age range: 6-18 years

"Healthy": ASA I and II

Disqualifiers

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

Trial population

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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

revitalization
Other intervention
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 .

Treatment groups

72 Participants

are divided into 2 treatment groups

Group A: with AP1 intervention

Group B: without AP1 intervention

Trial outcomes

Primary outcomes

radiographic root area (RRA)

RRA post revitalization

Time frame

1 year

Secondary outcomes

periapical health

Maintained or restored periapical health post revitalization

Time frame

1 year

Other outcomes

RRA 2 and 3 years post revitalization

RRA post revitalization

Time frame

2 and 3 years

Maintained or restored periapical health 2 and 3 years post revitalization (evaluated within each group separately)

periapical health

Time frame

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

Time frame

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

Time frame

3 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universitaire Ziekenhuizen KU Leuven

Lead sponsor

University Ghent

Collaborator

University of Erlangen-Nürnberg

Collaborator

University of Regensburg

Collaborator

University of Coimbra

Collaborator

Source ClinicalTrials.gov

Apply now