NCT04716478

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Typical duration for all trials

Geographic Reach
1 country

21 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 20, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

January 22, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

May 6, 2021

Status Verified

January 1, 2021

Enrollment Period

1.4 years

First QC Date

January 15, 2021

Last Update Submit

May 5, 2021

Conditions

Outcome Measures

Primary Outcomes (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.

    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.

Study Arms (1)

Patient in need of endodontic care

Other: Clinical and radiological data collection

Interventions

No specific intervention. Data of the usual care will be collected as the demographic data, the medical history, imaging report, etc.

Patient in need of endodontic care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patient with apical periodontitis

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

CHU de Bordeaux, Service de Médecine Buccodentaire

Bordeaux, France

NOT YET RECRUITING

CHU de Brest, Service d'Odontologie

Brest, France

NOT YET RECRUITING

Cabinet du Dr Baptiste Rivory

Lyon, France

RECRUITING

Cabinet du Dr Matthieu Durand

Lyon, France

RECRUITING

Cabinet du Dr Oussama Bouamar

Lyon, France

RECRUITING

Cabinet du Dr Paul-Marie Oliva

Lyon, France

RECRUITING

Hospices Civils de Lyon, Service d'Odontologie

Lyon, France

RECRUITING

UFR d'Odontologie, Laboratoire des Multimatériaux et Interfaces

Lyon, France

NOT YET RECRUITING

CHRU de Nancy, Service d'Odontologie

Nancy, France

NOT YET RECRUITING

CHU de Nantes, Service d'Odontologie

Nantes, France

RECRUITING

Cabinet du Dr Catherine Ricci

Nice, France

RECRUITING

Assistance Publique des Hôpitaux de Paris, Hôpital Bretonneau, Service d'Odontologie

Paris, France

NOT YET RECRUITING

Assistance Publique des Hôpitaux de Paris, Hôpital Charles Foix, Service d'Odontologie

Paris, France

NOT YET RECRUITING

Assistance Publique des Hôpitaux de Paris, Hôpital Henri Mondor, Service d'Odontologie

Paris, France

NOT YET RECRUITING

Assistance Publique des Hôpitaux de Paris, Hôpital Pitié Salpêtrière, Service d'Odontologie

Paris, France

NOT YET RECRUITING

Cabinet du Dr Cauris Couvrechel

Paris, France

RECRUITING

Cabinet du Dr Francois Bronnec

Paris, France

NOT YET RECRUITING

Cabinet du Dr Sandrine Dahan

Paris, France

NOT YET RECRUITING

Cabinet du Dr Valentin Marchi,

Paris, France

RECRUITING

CHU de Toulouse, Service d'Odontologie

Toulouse, France

NOT YET RECRUITING

Cabinet du Dr Stéphanie Lapon

Tours, France

NOT YET RECRUITING

MeSH Terms

Conditions

Periapical Periodontitis

Condition Hierarchy (Ancestors)

Periapical DiseasesJaw DiseasesStomatognathic DiseasesPeriodontal DiseasesMouth DiseasesPeriodontitis

Central Study Contacts

Brigitte GROSGOGEAT, DDS

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2021

First Posted

January 20, 2021

Study Start

January 22, 2021

Primary Completion

June 1, 2022

Study Completion

June 1, 2023

Last Updated

May 6, 2021

Record last verified: 2021-01

Locations