Clinical trial NCT04945993: Tooth Retention After Root Canal Treatment With Endomethasone N
Official title: Assessment of Tooth Retention 10 Years After Root Canal Treatment With Endomethasone N: a Retro-prospective, National and Multicentre Clinical Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Dental Root Canal Obturation
Lead sponsor: Septodont
Sponsor class: INDUSTRY
First posted: 2021-06-30
Enrollment: 179
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in need of root canal treatment.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Assessment of tooth functional retention
timeFrame: 10 years
Secondary outcomes:
measure: Assessment of tooth functional retention
timeFrame: 5 years
measure: Assessment of the tooth functional retention after Root Canal Treatment with Endomethasone N according to initial treatment or retreatment
timeFrame: 5 and 10 years
measure: Assessment of the periapical healing
timeFrame: 5 and 10 years
measure: The technical characteristics of the sealer Endomethasone N
timeFrame: 5 and 10 years
measure: The ease of use and insertion of Endomethasone N in the canal
timeFrame: 5 and 10 years
measure: The Investigator overall satisfaction of the experience with Endomethasone N
timeFrame: 5 and 10 years
measure: The immediate and long-term post-obturation adverse device effects
timeFrame: Immediately after root canal filling, and at long-term (i.e. 5 and 10 years)
Other outcomes:
Locations:
city: Athis-Mons
country: France
facility: Private dentist office - Dr PHAM
city: Dax
country: France
facility: Private dentist office - Dr LEBRET
city: Montélimar
country: France
facility: Private dentist office - Dr ROUBINET
city: Saint-Herblain
country: France
facility: Private dentist office - Dr AUBEUX
city: Valence
country: France
facility: Private dentist office - Dr JACOB
Study officials:
affiliation: Cabinet dentaire
name: Davy Aubeux, Dr
role: STUDY_DIRECTOR
affiliation: Cabinet dentaire
name: Frank LEBRET, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Cabinet dentaire
name: Vincent ROUBINET, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Cabinet dentaire
name: Alain PHAM, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Cabinet dentaire
name: Frederic JACOB
role: PRINCIPAL_INVESTIGATOR
References: