REone: Prospective Endodontics Database

Sponsor
Hospices Civils de Lyon (Other)
Overall Status
Recruiting
CT.gov ID
NCT04716478
Collaborator
(none)
400
21
28.3
19
0.7

Study Details

Study Description

Brief 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%. 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Clinical and radiological data collection

Study Design

Study Type:
Observational
Anticipated Enrollment :
400 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Creation of a Prospective Endodontics Database
Actual Study Start Date :
Jan 22, 2021
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. 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. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU de Bordeaux, Service de Médecine Buccodentaire Bordeaux France
2 CHU de Brest, Service d'Odontologie Brest France
3 Cabinet du Dr Baptiste Rivory Lyon France
4 Cabinet du Dr Matthieu Durand Lyon France
5 Cabinet du Dr Oussama Bouamar Lyon France
6 Cabinet du Dr Paul-Marie Oliva Lyon France
7 Hospices Civils de Lyon, Service d'Odontologie Lyon France
8 UFR d'Odontologie, Laboratoire des Multimatériaux et Interfaces Lyon France
9 CHRU de Nancy, Service d'Odontologie Nancy France
10 CHU de Nantes, Service d'Odontologie Nantes France
11 Cabinet du Dr Catherine Ricci Nice France
12 Assistance Publique des Hôpitaux de Paris, Hôpital Bretonneau, Service d'Odontologie Paris France
13 Assistance Publique des Hôpitaux de Paris, Hôpital Charles Foix, Service d'Odontologie Paris France
14 Assistance Publique des Hôpitaux de Paris, Hôpital Henri Mondor, Service d'Odontologie Paris France
15 Assistance Publique des Hôpitaux de Paris, Hôpital Pitié Salpêtrière, Service d'Odontologie Paris France
16 Cabinet du Dr Cauris Couvrechel Paris France
17 Cabinet du Dr Francois Bronnec Paris France
18 Cabinet du Dr Sandrine Dahan Paris France
19 Cabinet du Dr Valentin Marchi, Paris France
20 CHU de Toulouse, Service d'Odontologie Toulouse France
21 Cabinet du Dr Stéphanie Lapon Tours France

Sponsors and Collaborators

  • Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT04716478
Other Study ID Numbers:
  • 69HCL20_0833
First Posted:
Jan 20, 2021
Last Update Posted:
May 6, 2021
Last Verified:
Jan 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 6, 2021