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Tooth Retention After Root Canal Treatment With Endomethasone N

NCT04945993 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 179

Last updated 2026-05-06

No results posted yet for this study

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

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Septodont

    lead INDUSTRY

Principal Investigators

  • Davy Aubeux, Dr · Cabinet dentaire

  • Frank LEBRET, Dr · Cabinet dentaire

  • Vincent ROUBINET, Dr · Cabinet dentaire

  • Alain PHAM, Dr · Cabinet dentaire

  • Frederic JACOB · Cabinet dentaire

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-02
Primary Completion
2026-10-21
Completion
2026-12-21

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04945993 on ClinicalTrials.gov