Tooth Retention After Root Canal Treatment With Endomethasone N (ENDO2021-02)

Septodont

Status: Active, not recruiting

Conditions: Dental Root Canal Obturation

Treatments: Device: Endomethasone N

Study type: Observational

Funder types: Industry

Identifiers

NCT04945993

ENDO-N

Details and patient eligibility

About

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.

Enrollment: 179 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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