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

  • STATUS
    Recruiting
  • End date
    Dec 21, 2026
  • participants needed
    174
  • sponsor
    Septodont
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Updated on 23 March 2022
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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.

Details
Condition Dental Root Canal Obturation
Treatment Endomethasone N
Clinical Study IdentifierNCT04945993
SponsorSeptodont
Last Modified on23 March 2022

Eligibility

 Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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