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COMPLETED
NCT04885686
NA

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

Sponsor: Septodont

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2021-06-22

Completion Date

2022-06-11

Last Updated

2026-05-06

Healthy Volunteers

No

Interventions

DEVICE

Endomethasone N RCS

Root canal sealer

DEVICE

Endomethasone SP RCS

Root canal sealer

Locations (15)

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