Endodontic Post-operative Pain Evaluation of Patients After Using Endomethasone N or Endomethasone SP (EndoPOP)
- Conditions
- Root Canal Obturation
- Interventions
- Device: Endomethasone SP RCSDevice: Endomethasone N RCS
- Registration Number
- NCT04885686
- Lead Sponsor
- Septodont
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
- 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).
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Endomethasone SP RCS Endomethasone SP RCS Endomethasone SP RCS is used in combination with gutta percha points for the permanent obturation of root canals. Endomethasone N RCS Endomethasone N RCS Endomethasone N RCS is used in combination with gutta percha points for the permanent obturation of root canals.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (4)
Cabinet Dentaire
🇫🇷Cherbourg, France
Centre dentaire Flandre
🇫🇷Paris, France
Centre de santé dentaire Chevaleret
🇫🇷Paris, France
Cabinet dentaire
🇫🇷Équeurdreville-Hainneville, France