Prospective Endodontics Database (REone)

May 5, 2021 updated by: Hospices Civils de Lyon

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Bordeaux, France
        • Not yet recruiting
        • CHU de Bordeaux, Service de Médecine Buccodentaire
        • Contact:
          • Raphaël Devillard, DDS
      • Brest, France
        • Not yet recruiting
        • CHU de Brest, Service d'Odontologie
        • Contact:
          • Karen Vallaeys, DDS
      • Lyon, France
        • Recruiting
        • Cabinet du Dr Baptiste Rivory
        • Contact:
          • Baptiste Rivory, DDS
      • Lyon, France
        • Recruiting
        • Cabinet du Dr Matthieu Durand
        • Contact:
          • Matthieu Durand, DDS
      • Lyon, France
        • Recruiting
        • Cabinet du Dr Oussama Bouamar
        • Contact:
          • Oussama Bouamar, DDS
      • Lyon, France
        • Recruiting
        • Cabinet du Dr Paul-Marie Oliva
        • Contact:
          • Paul-Marie Oliva, DDS
      • Lyon, France
        • Recruiting
        • Hospices Civils de Lyon, Service d'Odontologie
        • Contact:
          • JC Maurin, DDS
      • Lyon, France
        • Not yet recruiting
        • UFR d'Odontologie, Laboratoire des Multimatériaux et Interfaces
      • Nancy, France
        • Not yet recruiting
        • CHRU de Nancy, Service d'Odontologie
        • Contact:
          • Rémy Baltazard, DDS
      • Nantes, France
        • Recruiting
        • CHU de Nantes, Service d'Odontologie
        • Contact:
          • Fabienne Perez, DDS
      • Nice, France
        • Recruiting
        • Cabinet du Dr Catherine Ricci
        • Contact:
          • Catherine Ricci, DDS
      • Paris, France
        • Not yet recruiting
        • Assistance Publique des Hôpitaux de Paris, Hôpital Bretonneau, Service d'Odontologie
        • Contact:
          • Fleur BERES, DDS
      • Paris, France
        • Not yet recruiting
        • Assistance Publique des Hôpitaux de Paris, Hôpital Charles Foix, Service d'Odontologie
        • Contact:
          • Tchilalo Boukpessi
      • Paris, France
        • Not yet recruiting
        • Assistance Publique des Hôpitaux de Paris, Hôpital Henri Mondor, Service d'Odontologie
        • Contact:
          • Catherine Besnault, DDS
      • Paris, France
        • Not yet recruiting
        • Assistance Publique des Hôpitaux de Paris, Hôpital Pitié Salpêtrière, Service d'Odontologie
        • Contact:
          • Marjorie Zanini, DDS
      • Paris, France
        • Recruiting
        • Cabinet du Dr Cauris Couvrechel
        • Contact:
          • Cauris Couvrechel, DDS
      • Paris, France
        • Not yet recruiting
        • Cabinet du Dr Francois Bronnec
        • Contact:
          • Francois Bronnec, DDS
      • Paris, France
        • Not yet recruiting
        • Cabinet du Dr Sandrine Dahan
        • Contact:
          • Sandrine Dahan, DDS
      • Paris, France
        • Recruiting
        • Cabinet du Dr Valentin Marchi,
        • Contact:
          • Valentin Marchi, DDS
      • Toulouse, France
        • Not yet recruiting
        • CHU de Toulouse, Service d'Odontologie
        • Contact:
          • Diemer Franck, DDS
      • Tours, France
        • Not yet recruiting
        • Cabinet du Dr Stéphanie Lapon
        • Contact:
          • Stéphanie Lapon, DDS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patient with apical periodontitis

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patient unable to understand the purpose and conduct of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Patient in need of endodontic care
Other: Clinical and radiological data collection
No specific intervention. Data of the usual care will be collected as the demographic data, the medical history, imaging report, etc.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
follow-up at 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 22, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 15, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 20, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 6, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 69HCL20_0833

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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