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

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

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 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

Ages Eligible for Study

16 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
Intervention / Treatment
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

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

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)

January 22, 2021

Primary Completion (Anticipated)

June 1, 2022

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

January 15, 2021

First Submitted That Met QC Criteria

January 15, 2021

First Posted (Actual)

January 20, 2021

Study Record Updates

Last Update Posted (Actual)

May 6, 2021

Last Update Submitted That Met QC Criteria

May 5, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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