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Endodontic Post-operative Pain Evaluation of Patients After Using Endomethasone N or Endomethasone SP (EndoPOP)
Sponsor: Septodont
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
Conditions
Interventions
Endomethasone N RCS
Root canal sealer
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