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

NCT04885686 | Completed

• 2 other identifiers: EndoPOP2021-A00065-36
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 15

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).

Conditions

Root Canal Obturation

Keywords

Endodontics; root canal sealer; post-operative pain; zinc oxide eugenol; hydrocortisone; corticoid; root canal treatment

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (7)

• Spontaneous pain intensity

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

• Occurrence of spontaneous pain flare-ups

  From Day 3 to Day7

• Masticatory pain intensity

  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)

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

• Use of oral pain treatment

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

Study Arms (2)

Endomethasone N RCS

EXPERIMENTAL

Endomethasone N RCS is used in combination with gutta percha points for the permanent obturation of root canals.

Device: Endomethasone N RCS

Endomethasone SP RCS

ACTIVE COMPARATOR

Endomethasone SP RCS is used in combination with gutta percha points for the permanent obturation of root canals.

Device: Endomethasone SP RCS

Interventions

Endomethasone N RCS DEVICE

Root canal sealer

Endomethasone N RCS

Endomethasone SP RCS DEVICE

Root canal sealer

Endomethasone SP RCS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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);
• 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)

Sponsors & Collaborators

• Septodont: lead
• Slb Pharma: collaborator

Study Sites (15)

Cabinet dentaire

Agon-Coutainville, 50230, France

Location

Cabinet dentaire

Betton, 35830, France

Location

Cabinet dentaire

Chartres-de-Bretagne, 35131, France

Location

Cabinet Dentaire

Cherbourg, 50100, France

Location

Cabinet dentaire

Cherbourg, 50110, France

Location

Cabinet dentaire

Dinan, 35800, France

Location

Cabinet dentaire

Équeurdreville-Hainneville, 50120, France

Location

Cabinet dentaire

Lamballe, 22400, France

Location

Centre de santé dentaire Chevaleret

Paris, 75013, France

Location

Centre dentaire Flandre

Paris, 75019, France

Location

Cabinet dentaire

Pluguffan, 29700, France

Location

Cabinet dentaire

Quimper, 29000, France

Location

Cabinet dentaire

Rennes, 35000, France

Location

Cabinet dentaire

Saint-Aubin-de-Médoc, 33160, France

Location

Cabinet dentaire

Tinténiac, 35190, France

Location

Related Publications (1)

• 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.

  PMID: 38644670 RESULT

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Yves BOUCHER, PU-PH

  APHP

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The color of the two powders are not the same. The dentist will not be blinded to the treatment, but the patient will. The study is simple-blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: May 13, 2021
• Study Start: June 22, 2021
• Primary Completion: July 6, 2021
• Study Completion: June 11, 2022
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (15)