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

Sponsor

Septodont (Industry)

Overall Status

Completed

CT.gov ID

NCT04885686

Collaborator

Slb Pharma (Other)

300

Enrollment

Locations

Arms

11.6

Actual Duration (Months)

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Root Canal Obturation	Device: Endomethasone N RCS Device: Endomethasone SP RCS	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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).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 (Participant)

Masking Description:

The color of the two powders are not the same. The dentist will not be blinded to the treatment, but the patient will. The study is simple-blinded.

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jun 22, 2021

Actual Primary Completion Date :

Jul 6, 2021

Actual Study Completion Date :

Jun 11, 2022

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Endomethasone N RCS

Endomethasone N RCS is used in combination with gutta percha points for the permanent obturation of root canals.

Device: Endomethasone N RCS

Root canal sealer

Active Comparator: Endomethasone SP RCS

Endomethasone SP RCS is used in combination with gutta percha points for the permanent obturation of root canals.

Device: Endomethasone SP RCS

Root canal sealer

Outcome Measures

Primary Outcome Measures

Maximum post-operative pain using a visual analogue scale (VAS : 0-100) [from the end of the root canal treatment (Day 0) to Day 7]
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.

Secondary Outcome Measures

Spontaneous pain intensity [from the end of the root canal treatment (Day 0) to Day 7]
The spontaneous pain intensity measured using a Visual Analogue Scale (VAS: 0-100mm; 0 no pain - 100 maximum pain)
Occurrence of spontaneous pain flare-ups [From Day 3 to Day7]
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.
Masticatory pain intensity [from the end of the root canal treatment (Day 0) to Day 7]
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).
Maximum Masticatory pain intensity using a visual analogue scale (VAS : 0-100mm) [from the end of the root canal treatment (Day 0) to Day 7]
The maximum masticatory pain intensity measured Visual Analogue Scale (VAS: 0-100mm; 0 no pain- 100 maximum pain)
Use of oral pain treatment [from the end of the root canal treatment (Day 0) to Day 7]
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.
Quality of life with the OHIP-17 questionnaire (score 0-68) [baseline and from 48 to 72 hours]
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.
Adverse events [from the inclusion (Day 0) to Day 7]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Cabinet dentaire	Agon-Coutainville	France	50230
2	Cabinet dentaire	Betton	France	35830
3	Cabinet dentaire	Chartres-de-Bretagne	France	35131
4	Cabinet Dentaire	Cherbourg	France	50100
5	Cabinet dentaire	Cherbourg	France	50110
6	Cabinet dentaire	Dinan	France	35800
7	Cabinet dentaire	Lamballe	France	22400
8	Centre de santé dentaire Chevaleret	Paris	France	75013
9	Centre dentaire Flandre	Paris	France	75019
10	Cabinet dentaire	Pluguffan	France	29700
11	Cabinet dentaire	Quimper	France	29000
12	Cabinet dentaire	Rennes	France	35000
13	Cabinet dentaire	Saint-Aubin-de-Médoc	France	33160
14	Cabinet dentaire	Tinténiac	France	35190
15	Cabinet dentaire	Équeurdreville-Hainneville	France	50120