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

Study Overview
=================
Brief 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

Conditions
-----------------
Root Canal Obturation

Intervention / Treatment
-----------------
* Device: Endomethasone N RCS
* Device: Endomethasone SP RCS


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Study subject will be randomized in a 1:1 allocation ratio between the 2 treatment groups; the allocation will be stratified by pre-operative pain (3 classes) and center (12 classes).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endomethasone N RCS<br>Endomethasone N RCS is used in combination with gutta percha points for the permanent obturation of root canals. | Device: Endomethasone N RCS<br>* Root canal sealer<br>|
| Active Comparator: Endomethasone SP RCS<br>Endomethasone SP RCS is used in combination with gutta percha points for the permanent obturation of root canals. | Device: Endomethasone SP RCS<br>* Root canal sealer<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | from the end of the root canal treatment (Day 0) to Day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spontaneous pain intensity | The spontaneous pain intensity measured using a Visual Analogue Scale (VAS: 0-100mm; 0 no pain - 100 maximum pain) | from the end of the root canal treatment (Day 0) to Day 7 | 
| Occurrence of spontaneous pain flare-ups | The occurrence of spontaneous pain flare-ups is an increase of 20 mm in the Visual Analogue Scale (VAS: 0-100mm; 0 no pain-100 maximum pain) between 2 consecutive measurements after the firsts 3 days. | From Day 3 to Day7 | 
| Masticatory pain intensity | The masticatory pain intensity measured using a Visual Analogue Scale (VAS: 0-100mm; 0 no pain -100 maximum pain) assessed twice a day from Day 0 to Day3 (lunch and dinner), and once a day from Day 4 to Day7 (dinner). | from the end of the root canal treatment (Day 0) to Day 7 | 
| Maximum Masticatory pain intensity using a visual analogue scale (VAS : 0-100mm) | The maximum masticatory pain intensity measured Visual Analogue Scale (VAS: 0-100mm; 0 no pain- 100 maximum pain) | from the end of the root canal treatment (Day 0) to Day 7 | 
| Use of oral pain treatment | Patients reported the consumption of analgesic treatment in a diary. The proportion of patients who took oral pain medication and the treatment categories will be compared between the 2 groups. | from the end of the root canal treatment (Day 0) to Day 7 | 
| Quality of life with the OHIP-17 questionnaire (score 0-68) | The answers and the total score from the OHIP 17-items questionnaire (measured at baseline and 48 h) will be compared between 2 groups. Score between 0 and 68, 0 means no dental issuel, 68 all the issues very often. | baseline and from 48 to 72 hours | 
| Adverse events | Adverse events reported by patients on a diary from Day 0 to Day 7 and adverse events clinically observed by the dental surgeon at each follow-up visit will be used to assess the safety of root canal sealers and endodontic procedures | from the inclusion (Day 0) to Day 7 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endodontics, root canal sealer, post-operative pain, zinc oxide eugenol, hydrocortisone, corticoid, root canal treatment