Tooth Retention After Root Canal Treatment With Endomethasone N

NCT ID: NCT04945993

Last Updated: 2023-11-29

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 179 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-07-02
• Study Completion Date: 2026-12-21

Brief Summary

The aim of root canal treatment, or endodontic treatment, is to treat pulpal or periapical diseases and thus transform a pathological tooth into a healthy, asymptomatic and functional entity on the dental arch. The diagnosis of pulp pathology is based on the symptomatology described by the patient, on data from the clinical examination and tests performed as well as the radiographic examinations.

Different families of root canal sealers are used in endodontics: cements based on zinc oxide-eugenol (ZOE), resin-based materials, and calcium silicate-based cements. They provide a stable and hermetic sealing. The Septodont laboratory has developed and manufactured endomethasone N, a zinc oxide-eugenol root canal sealer.

The aim of this retro-prospective PMCF study is to collect long term clinical and safety data on root canal obturation after treatment or retreatment by Endomethasone N.

Conditions

Dental Root Canal Obturation

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

Endomethasone N

Endomethasone N is a powder intended to be mixed extemporaneously with a eugenol-based liquid (i.e, Endomethasone Liquid) to obtain a permanent root canal sealer. After selection of dentists, they will screen consecutively and systematically eligible patients, will send them the Patient Information Letter and will enroll them in the clinical investigation if non opposition from the patient. Patient clinical data will be recorded in an electronic Case Report Form. Pseudonymized retro-alveolar radiographies at baseline consultation and at 5 and 10 years post-obturation consultations will be recorded in the e-CRF. These radiographies will be examined by 2 independent endodontists and the results of these examinations will be recorded in the e-CRF. Site data will be collected on a Site Questionnaire with Visual Analog Scales.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patient, male or female, > 18 years of age at the time of inclusion in the study
• Patient who had a non-surgical root canal treatment with Endomethasone N, in a context of an endodontic treatment, or retreatment, before 01-Mar-2016
• Having a documented patient follow-up visit (clinical examination and radiographic examination) at least 5 years after the endodontic treatment or retreatment with Endomethasone N
• Patient affiliated or beneficiary of a social security system
• Patient informed about the study and who confirm their non-opposition in participating in the study

Exclusion Criteria

• History of malignant tumors in the 5 years prior to the root canal treatment
• Non-stabilized systemic disease during the month prior to the root canal treatment (diabetes, hypertension, thyroid disorders, etc.)
• Patient who developed a systemic pathology after the root canal treatment with Endomethasone N
• Patient who had endodontic treatment with Endomethasone N obturation on a wisdom tooth
• Patient whose tooth has suspected perforation during endodontic treatment
• Patient suffering from active non-stabilized periodontitis, untreated during endodontic treatment
• Patients participating in an interventional clinical trial at the time of root canal treatment

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Septodont

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Davy Aubeux, Dr

Role: STUDY_DIRECTOR

Cabinet dentaire

Frank LEBRET, Dr

Role: PRINCIPAL_INVESTIGATOR

Cabinet dentaire

Vincent ROUBINET, Dr

Role: PRINCIPAL_INVESTIGATOR

Cabinet dentaire

Alain PHAM, Dr

Role: PRINCIPAL_INVESTIGATOR

Cabinet dentaire

Frederic JACOB

Role: PRINCIPAL_INVESTIGATOR

Cabinet dentaire

Locations

Private dentist office - Dr PHAM

Athis-Mons, , France

Private dentist office - Dr LEBRET

Dax, , France

Private dentist office - Dr ROUBINET

Montélimar, , France

Private dentist office - Dr AUBEUX

Saint-Herblain, , France

Private dentist office - Dr JACOB

Valence, , France

Countries

France

Other Identifiers

ENDO-N

Identifier Type: -

Identifier Source: org_study_id