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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of tooth functional retention | Rate of tooth functional retention after Root Canal Treatment with Endomethasone N | 10 years |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients in need of root canal treatment.
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Private dentist office - Dr PHAM | Athis-Mons | France | ||||
| Private dentist office - Dr LEBRET |
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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:
| 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:
| 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) |
| Dax |
| France |
| Private dentist office - Dr ROUBINET | Montélimar | France |
| Private dentist office - Dr AUBEUX | Saint-Herblain | France |
| Private dentist office - Dr JACOB | Valence | France |