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NCT Number: NCT06043453

Revitalization of Traumatized Immature Permanent Teeth

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.

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Key information

Conditions

Apical Periodontitis Jaw Diseases Mouth Diseases Periapical Diseases Periapical Periodontitis Periodontal Diseases Periodontitis Stomatognathic Diseases Trauma Wounds and Injuries

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ghent University

Ghent, 9000, Belgium

Location status: Recruiting

Location contact

Nastaran Meschi, MSc, PhD

CONTACT

[email protected]

+32476313889

About this study

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 .

Primary outcomes

  1. radiographic root area (RRA)

    Time frame: 1 year

    RRA post revitalization

Secondary outcomes

  1. periapical health

    Time frame: 1 year

    Maintained or restored periapical health post revitalization

Other outcomes

  1. RRA 2 and 3 years post revitalization

    Time frame: 2 and 3 years

    RRA post revitalization

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

    Time frame: 2 and 3 years

    periapical health

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

    Time frame: 1 to 3 years

    pulp sensitivity

  4. Tooth survival 3 years post revitalization (even if no further root development and incomplete periapical bone healing with no clinical symptoms).

    Time frame: 3 years

    tooth survival

Study contacts

Contact information is provided by the study sponsor or research team.

Nastaran Meschi, MSc, PhD

CONTACT

[email protected]

+32476313889

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

  • University Ghent
  • University of Coimbra
  • University of Erlangen-Nürnberg
  • University of Regensburg

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2028
Study completion
2030
First posted
Sep 21, 2023
Registry last updated
Jul 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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