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

Septodont

Status

Completed

Conditions

Root Canal Obturation

Treatments

Device: Endomethasone SP RCS

Device: Endomethasone N RCS

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04885686

EndoPOP

2021-A00065-36 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment

300 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)