Tooth Retention After Root Canal Treatment With Endomethasone N

NCT04945993 | Active Not Recruiting

• 1 other identifier: ENDO-N
• Study Type: observational
• Target: 179
• Locations: 1 country
• Sites: 5

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

Outcome Measures

Primary Outcomes (1)

• Assessment of tooth functional retention

  Rate of tooth functional retention after Root Canal Treatment with Endomethasone N

  10 years

Secondary Outcomes (7)

• Assessment of tooth functional retention

  5 years

• Assessment of the tooth functional retention after Root Canal Treatment with Endomethasone N according to initial treatment or retreatment

  5 and 10 years

• Assessment of the periapical healing

  5 and 10 years

• The technical characteristics of the sealer Endomethasone N

  5 and 10 years

• The ease of use and insertion of Endomethasone N in the canal

  5 and 10 years

Interventions

Endomethasone N DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients in need of root canal treatment.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Septodont: lead

Study Sites (5)

Private dentist office - Dr PHAM

Athis-Mons, France

Location

Private dentist office - Dr LEBRET

Dax, France

Location

Private dentist office - Dr ROUBINET

Montélimar, France

Location

Private dentist office - Dr AUBEUX

Saint-Herblain, France

Location

Private dentist office - Dr JACOB

Valence, France

Location

Study Officials

• Davy Aubeux, Dr

  Cabinet dentaire

  STUDY DIRECTOR

• Frank LEBRET, Dr

  Cabinet dentaire

  PRINCIPAL INVESTIGATOR

• Vincent ROUBINET, Dr

  Cabinet dentaire

  PRINCIPAL INVESTIGATOR

• Alain PHAM, Dr

  Cabinet dentaire

  PRINCIPAL INVESTIGATOR

• Frederic JACOB

  Cabinet dentaire

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2021
• First Posted: June 30, 2021
• Study Start: July 2, 2021
• Primary Completion (Estimated): October 21, 2026
• Study Completion (Estimated): December 21, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

FR (5)