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

April 30, 2026 updated by: Septodont

Endodontic Post-operative Pain Evaluation of Patients After Using Endomethasone N or Endomethasone SP Root Canal Sealer: a Prospective, Comparative Randomized Clinical Trial

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Agon-Coutainville, France, 50230
        • Cabinet dentaire
      • Betton, France, 35830
        • Cabinet dentaire
      • Chartres-de-Bretagne, France, 35131
        • Cabinet dentaire
      • Cherbourg, France, 50100
        • Cabinet dentaire
      • Cherbourg, France, 50110
        • Cabinet dentaire
      • Dinan, France, 35800
        • Cabinet dentaire
      • Lamballe, France, 22400
        • Cabinet dentaire
      • Paris, France, 75013
        • Centre de santé dentaire Chevaleret
      • Paris, France, 75019
        • Centre dentaire Flandre
      • Pluguffan, France, 29700
        • Cabinet dentaire
      • Quimper, France, 29000
        • Cabinet dentaire
      • Rennes, France, 35000
        • Cabinet dentaire
      • Saint-Aubin-de-Médoc, France, 33160
        • Cabinet dentaire
      • Tinténiac, France, 35190
        • Cabinet dentaire
      • Équeurdreville-Hainneville, France, 50120
        • Cabinet dentaire

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Endomethasone N RCS
Endomethasone N RCS is used in combination with gutta percha points for the permanent obturation of root canals.
Device: Endomethasone N RCS
Root canal sealer
Active Comparator: Endomethasone SP RCS
Endomethasone SP RCS is used in combination with gutta percha points for the permanent obturation of root canals.
Device: Endomethasone SP RCS
Root canal sealer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum post-operative pain using a visual analogue scale (VAS : 0-100)
Time Frame: from the end of the root canal treatment (Day 0) to Day 7
The pain is assessed by patients in a diary using a Visual Analogue Scale (VAS: 0-100 mm; 0 no pain - 100 maximum pain) at different times after endodontic treatment (at the end of the root canal obturation, 3h, 6h 12h, 24h, Day 2, Day 3, Day 4 Day 5, Day 5, Day 7). The maximum pain felt will be compared between the 2 groups.
from the end of the root canal treatment (Day 0) to Day 7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spontaneous pain intensity
Time Frame: from the end of the root canal treatment (Day 0) to Day 7
The spontaneous pain intensity measured using a Visual Analogue Scale (VAS: 0-100mm; 0 no pain - 100 maximum pain)
from the end of the root canal treatment (Day 0) to Day 7
Occurrence of spontaneous pain flare-ups
Time Frame: From Day 3 to Day7
The occurrence of spontaneous pain flare-ups is an increase of 20 mm in the Visual Analogue Scale (VAS: 0-100mm; 0 no pain-100 maximum pain) between 2 consecutive measurements after the firsts 3 days.
From Day 3 to Day7
Masticatory pain intensity
Time Frame: from the end of the root canal treatment (Day 0) to Day 7
The masticatory pain intensity measured using a Visual Analogue Scale (VAS: 0-100mm; 0 no pain -100 maximum pain) assessed twice a day from Day 0 to Day3 (lunch and dinner), and once a day from Day 4 to Day7 (dinner).
from the end of the root canal treatment (Day 0) to Day 7
Maximum Masticatory pain intensity using a visual analogue scale (VAS : 0-100mm)
Time Frame: from the end of the root canal treatment (Day 0) to Day 7
The maximum masticatory pain intensity measured Visual Analogue Scale (VAS: 0-100mm; 0 no pain- 100 maximum pain)
from the end of the root canal treatment (Day 0) to Day 7
Use of oral pain treatment
Time Frame: from the end of the root canal treatment (Day 0) to Day 7
Patients reported the consumption of analgesic treatment in a diary. The proportion of patients who took oral pain medication and the treatment categories will be compared between the 2 groups.
from the end of the root canal treatment (Day 0) to Day 7
Quality of life with the OHIP-17 questionnaire (score 0-68)
Time Frame: baseline and from 48 to 72 hours
The answers and the total score from the OHIP 17-items questionnaire (measured at baseline and 48 h) will be compared between 2 groups. Score between 0 and 68, 0 means no dental issuel, 68 all the issues very often.
baseline and from 48 to 72 hours
Adverse events
Time Frame: from the inclusion (Day 0) to Day 7
Adverse events reported by patients on a diary from Day 0 to Day 7 and adverse events clinically observed by the dental surgeon at each follow-up visit will be used to assess the safety of root canal sealers and endodontic procedures
from the inclusion (Day 0) to Day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Septodont

Collaborators

Slb Pharma

Investigators

  • Study Director: Yves BOUCHER, PU-PH, APHP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 22, 2021

Primary Completion (Actual)

July 6, 2021

Study Completion (Actual)

June 11, 2022

Study Registration Dates

First Submitted

April 29, 2021

First Submitted That Met QC Criteria

May 12, 2021

First Posted (Actual)

May 13, 2021

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EndoPOP
  • 2021-A00065-36 (Other Identifier: [French National Agency of Medicines and Health products])

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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