Prospective Endodontics Database

Apical Periodontitis Clinical Trial

— REone  

Official title:

Creation of a Prospective Endodontics Database

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04716478
• Other study ID #: 69HCL20_0833
• Status: Recruiting
• Start date: January 22, 2021
• Est. completion date: June 2023

Study information

• Verified date: January 2021
• Source: Hospices Civils de Lyon
• Contact: Brigitte GROSGOGEAT, DDS
• Phone: 003362162525
• Email: brigitte.grosgogeat[@]univ-lyon1.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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%. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: June 2023
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Apical Periodontitis
• Periapical Periodontitis
• Periodontitis

Intervention

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.

Locations

Country	Name	City	State
France	CHU de Bordeaux, Service de Médecine Buccodentaire	Bordeaux
France	CHU de Brest, Service d'Odontologie	Brest
France	Cabinet du Dr Baptiste Rivory	Lyon
France	Cabinet du Dr Matthieu Durand	Lyon
France	Cabinet du Dr Oussama Bouamar	Lyon
France	Cabinet du Dr Paul-Marie Oliva	Lyon
France	Hospices Civils de Lyon, Service d'Odontologie	Lyon
France	UFR d'Odontologie, Laboratoire des Multimatériaux et Interfaces	Lyon
France	CHRU de Nancy, Service d'Odontologie	Nancy
France	CHU de Nantes, Service d'Odontologie	Nantes
France	Cabinet du Dr Catherine Ricci	Nice
France	Assistance Publique des Hôpitaux de Paris, Hôpital Bretonneau, Service d'Odontologie	Paris
France	Assistance Publique des Hôpitaux de Paris, Hôpital Charles Foix, Service d'Odontologie	Paris
France	Assistance Publique des Hôpitaux de Paris, Hôpital Henri Mondor, Service d'Odontologie	Paris
France	Assistance Publique des Hôpitaux de Paris, Hôpital Pitié Salpêtrière, Service d'Odontologie	Paris
France	Cabinet du Dr Cauris Couvrechel	Paris
France	Cabinet du Dr Francois Bronnec	Paris
France	Cabinet du Dr Sandrine Dahan	Paris
France	Cabinet du Dr Valentin Marchi,	Paris
France	CHU de Toulouse, Service d'Odontologie	Toulouse
France	Cabinet du Dr Stéphanie Lapon	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	follow-up at 6 months.