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

NCT ID: NCT04885686

Last Updated: 2025-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-22
• Study Completion Date: 2022-06-11

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Endomethasone N RCS

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

Group Type: EXPERIMENTAL

Endomethasone N RCS

Intervention Type: DEVICE

Root canal sealer

Endomethasone SP RCS

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

Group Type: ACTIVE_COMPARATOR

Endomethasone SP RCS

Intervention Type: DEVICE

Root canal sealer

Interventions

Endomethasone N RCS

Root canal sealer

Intervention Type: DEVICE

Endomethasone SP RCS

Root canal sealer

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Slb Pharma

OTHER

Sponsor Role: collaborator

Septodont

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yves BOUCHER, PU-PH

Role: STUDY_DIRECTOR

APHP

Locations

Cabinet dentaire

Agon-Coutainville, , France

Cabinet dentaire

Betton, , France

Cabinet dentaire

Chartres-de-Bretagne, , France

Cabinet Dentaire

Cherbourg, , France

Cabinet dentaire

Cherbourg, , France

Cabinet dentaire

Dinan, , France

Cabinet dentaire

Équeurdreville-Hainneville, , France

Cabinet dentaire

Lamballe, , France

Centre de santé dentaire Chevaleret

Paris, , France

Centre dentaire Flandre

Paris, , France

Cabinet dentaire

Pluguffan, , France

Cabinet dentaire

Quimper, , France

Cabinet dentaire

Rennes, , France

Cabinet dentaire

Saint-Aubin-de-Médoc, , France

Cabinet dentaire

Tinténiac, , France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 38644670 (View on PubMed)

Other Identifiers

2021-A00065-36

Identifier Type: OTHER

Identifier Source: secondary_id

EndoPOP

Identifier Type: -

Identifier Source: org_study_id