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

Septodont300 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

300

Conditions

Root Canal Obturation

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

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

...and 5 more locations

Outcomes

Primary Outcomes

Maximum post-operative pain using a visual analogue scale (VAS : 0-100)

The pain is assessed by patients in a diary using a Visual Analogue Scale (VAS: 0-100 mm; 0 no pain - 100 maximum pain) at different times after endodontic treatment (at the end of the root canal obturation, 3h, 6h 12h, 24h, Day 2, Day 3, Day 4 Day 5, Day 5, Day 7). The maximum pain felt will be compared between the 2 groups.