Clinical trial NCT04885686: Endodontic Post-operative Pain Evaluation of Patients After Using Endomethasone N or Endomethasone SP (EndoPOP)
Official title: Endodontic Post-operative Pain Evaluation of Patients After Using Endomethasone N or Endomethasone SP Root Canal Sealer: a Prospective, Comparative Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Root Canal Obturation
Keywords: Endodontics
root canal sealer
post-operative pain
zinc oxide eugenol
hydrocortisone
corticoid
root canal treatment
Lead sponsor: Septodont
Sponsor class: INDUSTRY
Collaborators: name: Slb Pharma
First posted: 2021-05-13
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study subject will be randomized in a 1:1 allocation ratio between the 2 treatment groups; the allocation will be stratified by pre-operative pain (3 classes) and center (12 classes).
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: 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 clinical trial or subject still within the exclusion period of a previous clinical trial;
* Vulnerable subjects (art. L.1121-5 and L.1122-1-2, Code of Public Health, France; art. 66 of the Regulation (EU) 2017/745 on medical devices)

Primary outcomes:
measure: 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
Secondary outcomes:
measure: Spontaneous pain intensity
timeFrame: from the end of the root canal treatment (Day 0) to Day 7
measure: Occurrence of spontaneous pain flare-ups
timeFrame: From Day 3 to Day7
measure: Masticatory pain intensity
timeFrame: from the end of the root canal treatment (Day 0) to Day 7
measure: Maximum Masticatory pain intensity using a visual analogue scale (VAS : 0-100mm)
timeFrame: from the end of the root canal treatment (Day 0) to Day 7
measure: Use of oral pain treatment
timeFrame: from the end of the root canal treatment (Day 0) to Day 7
measure: Quality of life with the OHIP-17 questionnaire (score 0-68)
timeFrame: baseline and from 48 to 72 hours
measure: Adverse events
timeFrame: from the inclusion (Day 0) to Day 7
Other outcomes:
Locations:
city: Agon-Coutainville
country: France
facility: Cabinet dentaire
city: Betton
country: France
facility: Cabinet dentaire
city: Chartres-de-Bretagne
country: France
facility: Cabinet dentaire
city: Cherbourg
country: France
facility: Cabinet Dentaire
city: Cherbourg
country: France
facility: Cabinet dentaire
city: Dinan
country: France
facility: Cabinet dentaire
city: Lamballe
country: France
facility: Cabinet dentaire
city: Paris
country: France
facility: Centre de santé dentaire Chevaleret
city: Paris
country: France
facility: Centre dentaire Flandre
city: Pluguffan
country: France
facility: Cabinet dentaire
city: Quimper
country: France
facility: Cabinet dentaire
city: Rennes
country: France
facility: Cabinet dentaire
city: Saint-Aubin-de-Médoc
country: France
facility: Cabinet dentaire
city: Tinténiac
country: France
facility: Cabinet dentaire
city: Équeurdreville-Hainneville
country: France
facility: Cabinet dentaire
Study officials:
affiliation: APHP
name: Yves BOUCHER, PU-PH
role: STUDY_DIRECTOR
References:
citation: Boucher Y, Abrgall H, Bar V, Basl-Th Bault FO, Cano S, Colombel H, Le Guicher G, Cameli C. Spontaneous and Masticatory Post-endodontic Pain After Using Endomethasone N vs SP Root Canal Sealers: A Randomised Controlled Clinical Trial. Eur Endod J. 2024 Aug 22;9(3):218-230. doi: 10.14744/eej.2024.96977.