CompletedNot Applicable

Endodontic Post-operative Pain Evaluation of Patients After Using Endomethasone N or Endomethasone SP (EndoPOP)

France300 participantsStarted 2021-06-22

Plain-language summary

The study is a post-marketing performance and safety study, designed as a comparative, prospective, multicenter, simple-blind, randomized clinical trial. 300 subjects requiring a primary or a secondary root canal treatment will be enrolled in 2 groups (150 in each group). The aim of the study is to demonstrate the superiority of the hydrocortisone-containing root canal sealer Endomethasone N RCS, compared to the hydrocortisone-free root canal sealer Endomethasone SP RCS, with regard to reduction of the maximum post-operative spontaneous pain during the 7 days following the root canal treatment. Root canal treatment procedures will be in accordance with the allocation by randomisation of Endomethasone N RCS or Endomethasone SP RCS. The spontaneous and the Masticatory pain will be record at predefined times, a phone call will be done at 48h and a visit will be realized at day 7 (max Day 14).

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adult male or female (age ≥ 18 years); * Patient requiring root canal treatment or retreatment; * Patient who will need a single visit for the root canal therapy, for a mature molar or second premolar, with or without pre-operative pain * Patient who received information and gave written consent (signed informed consent form); * Subject affiliated to a health insurance system, or is a beneficiary (art. L.1121-11, Code of Public Health, France). Exclusion Criteria: * Pulpotomy or pulpectomy performed at a prior visit; * Tooth with apical calcification (sealer unable to reach the root apex); * Tooth with suspected root perforation; * Immature tooth (too wide root apex requiring an apexification); * Other dental treatment ongoing or scheduled within the study period; * At least one symptomatic tooth among those that are not included in this study * Known hypersensitivity to steroids, local anesthetics, or any component of study medical devices; * Subject using long term anti-inflammatory drugs; * Use of illicit substances during the 48h before the first visit (cannabis, cocaine…); * Presence of any significant medical finding or significant history such as uncontrolled systemic diseases that may impact the safety, the interpretation of the results and/or the participation of the subject in the study according to the opinion of the investigator; * Subject who cannot be contacted in case of emergency (phone number); * Simultaneous participation in another …

What they're measuring

Maximum post-operative pain using a visual analogue scale (VAS : 0-100)

Timeframe: from the end of the root canal treatment (Day 0) to Day 7

Trial details

NCT IDNCT04885686

SponsorSeptodont

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-07-06