Active, Not Recruiting

NCT Number: NCT04945993

Tooth Retention After Root Canal Treatment With Endomethasone N

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Dental Root Canal Obturation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Private dentist office - Dr PHAM, Athis-Mons, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

Assessment of tooth functional retention

Time frame: 10 years

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

Secondary outcomes

Assessment of tooth functional retention

Time frame: 5 years

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

Time frame: 5 and 10 years

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
Assessment of the periapical healing

Time frame: 5 and 10 years
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
The technical characteristics of the sealer Endomethasone N

Time frame: 5 and 10 years
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
The ease of use and insertion of Endomethasone N in the canal

Time frame: 5 and 10 years

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).
The Investigator overall satisfaction of the experience with Endomethasone N

Time frame: 5 and 10 years

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).
The immediate and long-term post-obturation adverse device effects

Time frame: Immediately after root canal filling, and at long-term (i.e. 5 and 10 years)

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

Sponsors and collaborators

Lead sponsor

Septodont

Industry

Registry information

Official study title

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

Acronym: ENDO2021-02

Important dates

Study start: 2021
Primary completion: 2026
Study completion: 2026
First posted: Jun 30, 2021
Registry last updated: May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.