Revitalization of Traumatized Immature Permanent Teeth

Trauma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06043453
• Other study ID #: S67181
• Status: Recruiting
• Start date: October 1, 2023
• Est. completion date: September 1, 2030

Study information

• Verified date: August 2023
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: Nastaran Meschi, MSc, PhD
• Phone: +32476313889
• Email: nastaran.meschi[@]ugent.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: September 1, 2030
• Est. primary completion date: September 1, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Apical Periodontitis
• Periapical Periodontitis
• Periodontitis
• Trauma

Intervention

Other:
• 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 .

Locations

Country	Name	City	State
Belgium	Ghent University	Ghent

Sponsors (5)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven	Ghent University, Belgium, University of Coimbra, University of Erlangen-Nürnberg, University of Regensburg

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	RRA 2 and 3 years post revitalization	RRA post revitalization	2 and 3 years
Other	Maintained or restored periapical health 2 and 3 years post revitalization (evaluated within each group separately)	periapical health	2 and 3 years
Other	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
Other	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
Primary	radiographic root area (RRA)	RRA post revitalization	1 year
Secondary	periapical health	Maintained or restored periapical health post revitalization	1 year