Revitalization of Traumatized Immature Permanent Teeth

Sponsor

Universitaire Ziekenhuizen KU Leuven (Other)

Overall Status

Recruiting

CT.gov ID

NCT06043453

Collaborator

Ghent University, Belgium (Other), University of Erlangen-Nürnberg (Other), University of Regensburg (Other), University of Coimbra (Other)

Enrollment

Location

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Apical Periodontitis Trauma	Other: revitalization

Detailed Description

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

72 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2028

Anticipated Study Completion Date :

Sep 1, 2030

Arms and Interventions

Arm	Intervention/Treatment
with AP	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 .
without AP	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 .

Arm

Intervention/Treatment

with AP

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 .

without AP

Other: revitalization

Outcome Measures

Primary Outcome Measures

radiographic root area (RRA) [1 year]
RRA post revitalization

Secondary Outcome Measures

periapical health [1 year]
Maintained or restored periapical health post revitalization

Other Outcome Measures

RRA 2 and 3 years post revitalization [2 and 3 years]
RRA post revitalization
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 18 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ghent University	Ghent		Belgium	9000

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Universitaire Ziekenhuizen KU Leuven

ClinicalTrials.gov Identifier:

NCT06043453

Other Study ID Numbers:

S67181

First Posted:

Sep 21, 2023

Last Update Posted:

Sep 21, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Periodontitis

Periapical Periodontitis

Study Results

No Results Posted as of Sep 21, 2023