Status:
COMPLETED
Endodontic Post-operative Pain Evaluation of Patients After Using Endomethasone N or Endomethasone SP (EndoPOP)
Lead Sponsor:
Septodont
Collaborating Sponsors:
Slb Pharma
Conditions:
Root Canal Obturation
Eligibility:
All Genders
18+ years
Phase:
NA
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 secondar...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
June 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 11 2022
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04885686
Start Date
June 22 2021
End Date
June 11 2022
Last Update
April 6 2025
Active Locations (15)
Enter a location and click search to find clinical trials sorted by distance.
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