Apical PeriodontitisREoneNCT04716478
Prospective Endodontics Database
An observational study of Apical Periodontitis, run by Hospices Civils de Lyon at 21 sites in France.
Trial summary
Endodontic treatment is necessary after certain dental trauma or in the presence of a large carious lesion, associated with signs of irreversible pulpal inflammation. The treatment of apical periodontitis is a real public health issue. The endodontic success rate is between 68 and 85%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Apical Periodontitis
- What is being tested?
- Clinical and radiological data collection
- How many people
- 400 participants
- Where
- 21 sitesFrance
- Study dates
- 22 Jan 2021to Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patient with apical periodontitis
Who may be able to join
- Adult patient aged ≥ 18,
- New patients received in consultation by students registered for a Diploma in Endodontics in one of the participating centres (Brest, Bordeaux, Lyon, Nancy, Nantes, Nice, Paris, Toulouse) or received by one of the private practitioners participating in the study;
- Patient with an indication for endodontic treatment or endodontic retreatment on at least one permanent tooth.
Who cannot join
- Patient unable to understand the purpose and conduct of the study.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
France21 sites, 21 recruiting
- Not yet recruiting
CHU de Bordeaux, Service de Médecine Buccodentaire
Bordeaux
Raphaël Devillard, DDS
- Not yet recruiting
CHU de Brest, Service d'Odontologie
Brest
Karen Vallaeys, DDS
- Recruiting
Cabinet du Dr Baptiste Rivory
Lyon
Baptiste Rivory, DDS
- Recruiting
Cabinet du Dr Matthieu Durand
Lyon
Matthieu Durand, DDS
- Recruiting
Cabinet du Dr Oussama Bouamar
Lyon
Oussama Bouamar, DDS
- Recruiting
Cabinet du Dr Paul-Marie Oliva
Lyon
Paul-Marie Oliva, DDS
- Recruiting
Hospices Civils de Lyon, Service d'Odontologie
Lyon
JC Maurin, DDS
- Not yet recruiting
UFR d'Odontologie, Laboratoire des Multimatériaux et Interfaces
Lyon
- Not yet recruiting
CHRU de Nancy, Service d'Odontologie
Nancy
Rémy Baltazard, DDS
- Recruiting
CHU de Nantes, Service d'Odontologie
Nantes
Fabienne Perez, DDS
- Recruiting
Cabinet du Dr Catherine Ricci
Nice
Catherine Ricci, DDS
- Not yet recruiting
Assistance Publique des Hôpitaux de Paris, Hôpital Bretonneau, Service d'Odontologie
Paris
Fleur BERES, DDS
- Not yet recruiting
Assistance Publique des Hôpitaux de Paris, Hôpital Charles Foix, Service d'Odontologie
Paris
Tchilalo Boukpessi
- Not yet recruiting
Assistance Publique des Hôpitaux de Paris, Hôpital Henri Mondor, Service d'Odontologie
Paris
Catherine Besnault, DDS
- Not yet recruiting
Assistance Publique des Hôpitaux de Paris, Hôpital Pitié Salpêtrière, Service d'Odontologie
Paris
Marjorie Zanini, DDS
- Recruiting
Cabinet du Dr Cauris Couvrechel
Paris
Cauris Couvrechel, DDS
- Not yet recruiting
Cabinet du Dr Francois Bronnec
Paris
Francois Bronnec, DDS
- Not yet recruiting
Cabinet du Dr Sandrine Dahan
Paris
Sandrine Dahan, DDS
- Recruiting
Cabinet du Dr Valentin Marchi,
Paris
Valentin Marchi, DDS
- Not yet recruiting
CHU de Toulouse, Service d'Odontologie
Toulouse
Diemer Franck, DDS
- Not yet recruiting
Cabinet du Dr Stéphanie Lapon
Tours
Stéphanie Lapon, DDS
About this study
Official title: Creation of a Prospective Endodontics Database
Endodontic treatment is necessary after certain dental trauma or in the presence of a large carious lesion, associated with signs of irreversible pulpal inflammation. The treatment of apical periodontitis is a real public health issue. The endodontic success rate is between 68 and 85%. Indeed, some studies show that systemic diseases such as diabetes can increase the prevalence and bone loss associated with apical periodontitis. Other studies identify apical periodontitis as a factor that can potentiate symptoms caused by inflammatory diseases such as cardiovascular disease and diabetes by increasing the level of inflammatory cells in the blood.
However, since 2014 the European Society of Endodontology has recommended establishing a higher level of evidence to ensure the link that these pathologies may have. For this, it is necessary to assess the criteria that may influence the healing of apical periodontitis.
Endodata has been developed by dental surgeons specializing in endodontics. The purpose of this software is to improve the clinical follow-up of patients and to establish a clinical and radiological database. In this context, the creation of a clinical database including data for all root canal treatment is of high interest.
- Conditions
- Apical Periodontitis
- Being tested
- Clinical and radiological data collection
- Medical subject headings
- Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical and radiological data collectionOther
No specific intervention. Data of the usual care will be collected as the demographic data, the medical history, imaging report, etc.
| Study group | Role | What they receive |
|---|---|---|
| Patient in need of endodontic care | Not described Receives: Other: Clinical and radiological data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The main objective is to build a database with the necessary, relevant and quality data that will allow the development of a diagnostic and therapeutic aid in endodontics.
The patient's medical pathologies, the results of tests and clinical examination, radiological analysis and diagnostics is recorded during routine care. The treatment protocol is detailed for each technique, product or material used.
Measured: follow-up at 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start22 Jan 2021
- Primary completion1 Jun 2022 (estimated)
- Study completionJun 2023 (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 Hospices Civils de LyonThe 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04716478
- Sponsor's protocol ID
- 69HCL20_0833
- Acronym
- REone
- Status last verified
- Jan 2021
- First submitted
- 15 Jan 2021
- Last updated
- 6 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creation of a Prospective Endodontics Database
- ClinicalTrials.gov ID
- NCT04716478
- Acronym / sponsor ID
- REone / 69HCL20_0833
- Conditions
- Apical Periodontitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 22 Jan 2021 (actual)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 20 Jan 2021 (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.
Endodontic treatment is necessary after certain dental trauma or in the presence of a large carious lesion, associated with signs of irreversible pulpal inflammation. The treatment of apical periodontitis is a real public health issue. The endodontic success rate is between 68 and 85%. Indeed, some studies show that systemic diseases such as diabetes can increase the prevalence and bone loss associated with apical periodontitis. Other studies identify apical periodontitis as a factor that can potentiate symptoms caused by inflammatory diseases such as cardiovascular disease and diabetes by increasing the level of inflammatory cells in the blood.
However, since 2014 the European Society of Endodontology has recommended establishing a higher level of evidence to ensure the link that these pathologies may have. For this, it is necessary to assess the criteria that may influence the healing of apical periodontitis.
Endodata has been developed by dental surgeons specializing in endodontics. The purpose of this software is to improve the clinical follow-up of patients and to establish a clinical and radiological database. In this context, the creation of a clinical database including data for all root canal treatment is of high interest.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient in need of endodontic care | – | Other: Clinical and radiological data collection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patient with apical periodontitis
Key inclusion criteria (3 listed)
- Adult patient aged ≥ 18,
- New patients received in consultation by students registered for a Diploma in Endodontics in one of the participating centres (Brest, Bordeaux, Lyon, Nancy, Nantes, Nice, Paris, Toulouse) or received by one of the private practitioners participating in the study;
- Patient with an indication for endodontic treatment or endodontic retreatment on at least one permanent tooth.
Key exclusion criteria (1 listed)
- Patient unable to understand the purpose and conduct of the study.
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 |
|---|---|---|
| Clinical and radiological data collectionNo specific intervention. Data of the usual care will be collected as the demographic data, the medical history, imaging report, etc. | Other | Patient in need of endodontic care |
Primary outcome
The main objective is to build a database with the necessary, relevant and quality data that will allow the development of a diagnostic and therapeutic aid in endodontics.
Time frame: follow-up at 6 months.
The patient's medical pathologies, the results of tests and clinical examination, radiological analysis and diagnostics is recorded during routine care. The treatment protocol is detailed for each technique, product or material used.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2021.
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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. This study is not recruiting at the moment.
21 sites 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, run by Hospices Civils de Lyon at 21 sites in France.
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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 6 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brigitte GROSGOGEAT, DDS (003362162525, brigitte.grosgogeat@univ-lyon1.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The main objective is to build a database with the necessary, relevant and quality data that will allow the development of a diagnostic and therapeutic aid in endodontics. (time frame: follow-up at 6 months.). 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 6 May 2021.