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

Assessment of Tooth Retention 10 Years After Root Canal Treatment With Endomethasone N: a Retro-prospective, National and Multicentre Clinical Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Dental Root Canal Obturation
• Intervention / Treatment: Device: Endomethasone N

• Study Type: Observational
• Enrollment (Actual): 179

Contacts and Locations

Study Locations

• France
  • Athis-Mons, France
    • Private dentist office - Dr PHAM
  • Dax, France
    • Private dentist office - Dr LEBRET
  • Montélimar, France
    • Private dentist office - Dr ROUBINET
  • Saint-Herblain, France
    • Private dentist office - Dr AUBEUX
  • Valence, France
    • Private dentist office - Dr JACOB

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients in need of root canal treatment.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of tooth functional retention	Rate of tooth functional retention after Root Canal Treatment with Endomethasone N	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of tooth functional retention	Rate of tooth functional retention after Root Canal Treatment with Endomethasone N.	5 years
Assessment of the tooth functional retention after Root Canal Treatment with Endomethasone N according to initial treatment or retreatment	Rate of tooth functional retention after Root Canal Treatment with Endomethasone N according to initial treatment or retreatment, on the basis of the same definition above	5 and 10 years
Assessment of the periapical healing	The periapical healing (success of obturation with Endomethasone N based on radiological criteria) at 5 and 10 years after Root Canal Treatment, will be evaluated in patients with retro-alveolar radiographs at the follow-up consultation (in parallel of the baseline consultation). The periapical healing is defined as follows: a periapical status considered "normal" (PAI score <3) (See Appendix 2); no resorption of the filling cement in the root, detectable on radiography; dense and homogeneous filling, limited to the canal,; a filling with the maintenance of the canal anatomy	5 and 10 years
The technical characteristics of the sealer Endomethasone N	The technical characteristics of the sealer Endomethasone N at 5 and 10 years after Root Canal Treatment "Not resorbable once hardened", "Not retractable over the years" and "Radiopaque" will be evaluated in patients with retro-alveolar radiographs at the follow-up consultation (in parallel of the baseline consultation). The technical characteristics are defined as follows: no resorption of the filling cement in the root, detectable on radiography; dense and homogeneous filling, limited to the canal, with no apparent void along the root canal walls; a filling with the maintenance of the canal anatomy	5 and 10 years
The ease of use and insertion of Endomethasone N in the canal	The ease of use and insertion of Endomethasone N in the canal will be evaluated with the score obtained on the Visual Analog Scale: score from 0 (Not at all) to 10 (Certainly Yes).	5 and 10 years
The Investigator overall satisfaction of the experience with Endomethasone N	The Investigator overall satisfaction of the experience with Endomethasone N will be evaluated at 5 and 10 years after Root Canal Obturation with the score obtained on the Visual Analog Scale : score from 0 (Not at all) to 10 (Certainly Yes).	5 and 10 years
The immediate and long-term post-obturation adverse device effects	The immediate and long-term post-obturation adverse device effects will be evaluated with the list of adverse events immediately appearing after root canal filling and appearing at long-term (5 and 10 years) after root canal filling	Immediately after root canal filling, and at long-term (i.e. 5 and 10 years)

Collaborators and Investigators

• Sponsor: Septodont
• Investigators: Study Director: Davy Aubeux, Dr, Cabinet dentaire; Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2021
• Primary Completion (Estimated): October 21, 2026
• Study Completion (Estimated): December 21, 2026

Study Registration Dates

• First Submitted: June 15, 2021
• First Submitted That Met QC Criteria: June 22, 2021
• First Posted (Actual): June 30, 2021

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: ENDO-N

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No