Endodontic Post-operative Pain Evaluation of Patients After Using Endomethasone N or Endomethason… (NCT04885686) | Clinical Trial Compass
CompletedNot Applicable
Endodontic Post-operative Pain Evaluation of Patients After Using Endomethasone N or Endomethasone SP (EndoPOP)
France300 participantsStarted 2021-06-22
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum post-operative pain using a visual analogue scale (VAS : 0-100)
Timeframe: from the end of the root canal treatment (Day 0) to Day 7