Revitalization of Traumatized Immature Permanent Teeth

NCT06043453 | Recruiting

• 1 other identifier: S67181
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Apical Periodontitis; Trauma

Outcome Measures

Primary Outcomes (1)

• radiographic root area (RRA)

  RRA post revitalization

  1 year

Secondary Outcomes (1)

• periapical health

  1 year

Other Outcomes (4)

• RRA 2 and 3 years post revitalization

  2 and 3 years

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

  2 and 3 years

• Pulp sensitivity 1-3 years post revitalization (evaluated within each group separately due to expected baseline inequivalency between groups)

  1 to 3 years

Study Arms (2)

with AP

Other: revitalization

without AP

Other: revitalization

Interventions

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 .

with AP; without AP

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• University Ghent: collaborator
• University of Erlangen-Nürnberg: collaborator
• University of Regensburg: collaborator
• University of Coimbra: collaborator

Study Sites (1)

Ghent University

Ghent, 9000, Belgium

RECRUITING

MeSH Terms

Conditions

Periapical Periodontitis; Wounds and Injuries

Interventions

Air Conditioning

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Intervention Hierarchy (Ancestors)

Environment, Controlled; Environment; Environment and Public Health

Central Study Contacts

Nastaran Meschi, MSc, PhD

CONTACT

+32476313889; nastaran.meschi@ugent.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2023
• First Posted: September 21, 2023
• Study Start: October 1, 2023
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2030
• Last Updated: July 1, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)