Dental Root Canal ObturationENDO2021-02NCT04945993
Tooth Retention After Root Canal Treatment With Endomethasone N
An observational study of Dental Root Canal Obturation, run by Septodont at 5 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Root Canal Obturation
- What is being tested?
- Endomethasone N
- Type of treatment
- Medical device
- How many people
- 179 participants
- Where
- 5 sitesFrance
- Study dates
- 2 Jul 2021to 21 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients in need of root canal treatment.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Private dentist office - Dr PHAM
Athis-Mons
Private dentist office - Dr LEBRET
Dax
Private dentist office - Dr ROUBINET
Montélimar
Private dentist office - Dr AUBEUX
Saint-Herblain
Private dentist office - Dr JACOB
Valence
About this study
Official title: 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.
- Conditions
- Dental Root Canal Obturation
- Being tested
- Endomethasone N
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endomethasone NDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of tooth functional retention
Rate of tooth functional retention after Root Canal Treatment with Endomethasone N
Measured: 10 years
Secondary outcomes (7)
Assessment of tooth functional retention
Rate of tooth functional retention after Root Canal Treatment with Endomethasone N.
Measured: 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
Measured: 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
Measured: 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
Measured: 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).
Measured: 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).
Measured: 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
Measured: Immediately after root canal filling, and at long-term (i.e. 5 and 10 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2021
- Study start2 Jul 2021
- Primary completion21 Oct 2026 (estimated)
- Study completion21 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Root Canal ObturationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Septodont
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Davy Aubeux, Dr, Study director, Cabinet dentaireFrank LEBRET, Dr, Principal investigator, Cabinet dentaireVincent ROUBINET, Dr, Principal investigator, Cabinet dentaireAlain PHAM, Dr, Principal investigator, Cabinet dentaireFrederic JACOB, Principal investigator, Cabinet dentaire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04945993
- Sponsor's protocol ID
- ENDO-N
- Acronym
- ENDO2021-02
- Status last verified
- Apr 2026
- First submitted
- 15 Jun 2021
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Tooth Retention 10 Years After Root Canal Treatment With Endomethasone N: a Retro-prospective, National and Multicentre Clinical Study
- ClinicalTrials.gov ID
- NCT04945993
- Acronym / sponsor ID
- ENDO2021-02 / ENDO-N
- Conditions
- Dental Root Canal Obturation
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 179 participants (actual)
- Lead sponsor
- SeptodontIndustry (pharma, biotech, devices)
- Study start
- 2 Jul 2021 (actual)
- Primary completion
- 21 Oct 2026 (estimated)
- Study completion
- 21 Dec 2026 (estimated)
- First posted
- 30 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in need of root canal treatment.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endomethasone NEndomethasone 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. | Device | – |
Primary outcome
Assessment of tooth functional retention
Time frame: 10 years
Rate of tooth functional retention after Root Canal Treatment with Endomethasone N
7 secondary outcomes
Assessment of tooth functional retention
Time frame: 5 years
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
Assessment of the periapical healing
Time frame: 5 and 10 years
The technical characteristics of the sealer Endomethasone N
Time frame: 5 and 10 years
The ease of use and insertion of Endomethasone N in the canal
Time frame: 5 and 10 years
The Investigator overall satisfaction of the experience with Endomethasone N
Time frame: 5 and 10 years
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Dental Root Canal Obturation
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Comparing Obturation Using Bioceramic Nano-coated Gutta-percha With Bioceramic Sealer Versus Traditional Gutta-percha With Resin Sealer for Reducing Postoperative Pain and Swelling After Root Canal Treatment in Necrotic Single-rooted Teeth.
Dental Pain, Facial Swelling
Recruiting
Success of Endodontic Treatment With Different Obturation Techniques and Sealer Cements
Pulpitis, Periapical Lesions
Recruiting
A Study to Assess the Clinical Success of Root Canal Treatment Using Novel Obturation Material.
Endodontic Treatment
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Davy Aubeux, Dr study director
Cabinet dentaire
Frank LEBRET, Dr principal investigator
Cabinet dentaire
Vincent ROUBINET, Dr principal investigator
Cabinet dentaire
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Root Canal Obturation, run by Septodont at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of tooth functional retention (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.