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

NCT04885686 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2026-05-06

No results posted yet for this study

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

Interventions

DEVICE

Endomethasone N RCS

Root canal sealer

DEVICE

Endomethasone SP RCS

Root canal sealer

Sponsors & Collaborators

  • Slb Pharma

    collaborator OTHER

  • Septodont

    lead INDUSTRY

Principal Investigators

  • Yves BOUCHER, PU-PH · APHP

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-22
Primary Completion
2021-07-06
Completion
2022-06-11

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04885686 on ClinicalTrials.gov