Apical PeriodontitisNCT06043453
Revitalization of Traumatized Immature Permanent Teeth
An observational study of Apical Periodontitis and Trauma, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Apical Periodontitis, Trauma
- What is being tested?
- revitalization
- How many people
- 72 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Oct 2023to 1 Sep 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Ghent University
Ghent, 9000
Nastaran Meschi, MSc, PhD, +32476313889, nastaran.meschi@ugent.be
About this study
Official title: Revitalization of Immature Permanent Teeth With or Without Apical Periodontitis Post Trauma: a European Multicenter Cohort Study
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.
Read the 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.
- Conditions
- Apical Periodontitis, Trauma
- Being tested
- revitalization
- Medical subject headings
- Periapical Periodontitis, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
revitalizationOther
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 .
| Study group | Role | What they receive |
|---|---|---|
| with AP | Not described Receives: Other: revitalization | |
| without AP | Not described Receives: Other: revitalization |
What is being measured
The primary outcome is the main question the study is designed to answer.
radiographic root area (RRA)
RRA post revitalization
Measured: 1 year
Secondary outcomes (1)
periapical health
Maintained or restored periapical health post revitalization
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start1 Oct 2023
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apical PeriodontitisStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent, University of Erlangen-Nürnberg, University of Regensburg, University of Coimbra
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06043453
- Sponsor's protocol ID
- S67181
- Status last verified
- Aug 2023
- First submitted
- 12 Sep 2023
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Revitalization of Immature Permanent Teeth With or Without Apical Periodontitis Post Trauma: a European Multicenter Cohort Study
- ClinicalTrials.gov ID
- NCT06043453
- Acronym / sponsor ID
- S67181
- Conditions
- Apical Periodontitis, Trauma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- University Ghent, University of Erlangen-Nürnberg, University of Regensburg, University of Coimbra
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2030 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| with AP | – | Other: revitalization |
| without AP | – | Other: revitalization |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| revitalizationThe 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 . | Other | with AP, without AP |
Primary outcome
radiographic root area (RRA)
Time frame: 1 year
RRA post revitalization
1 secondary outcome
periapical health
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Apical Periodontitis and Trauma, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nastaran Meschi, MSc, PhD (+32476313889, nastaran.meschi@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
radiographic root area (RRA) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2024.