Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2021-A00065-36 | Other Identifier | [French National Agency of Medicines and Health products] |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Slb Pharma | OTHER |
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endomethasone N RCS | Experimental | Endomethasone N RCS is used in combination with gutta percha points for the permanent obturation of root canals. |
|
| Endomethasone SP RCS | Active Comparator | Endomethasone SP RCS is used in combination with gutta percha points for the permanent obturation of root canals. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endomethasone N RCS | Device | Root canal sealer |
| |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Yves BOUCHER, PU-PH | APHP | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cabinet dentaire | Agon-Coutainville | 50230 | France | |||
| Cabinet dentaire |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38644670 | Result | Boucher Y, Abrgall H, Bar V, Basl-Th Bault FO, Cano S, Colombel H, Le Guicher G, Cameli C. Spontaneous and Masticatory Post-endodontic Pain After Using Endomethasone N vs SP Root Canal Sealers: A Randomised Controlled Clinical Trial. Eur Endod J. 2024 Aug 22;9(3):218-230. doi: 10.14744/eej.2024.96977. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
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.
| Endomethasone SP RCS |
| Device |
Root canal sealer |
|
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 |
| Betton |
| 35830 |
| France |
| Cabinet dentaire | Chartres-de-Bretagne | 35131 | France |
| Cabinet Dentaire | Cherbourg | 50100 | France |
| Cabinet dentaire | Cherbourg | 50110 | France |
| Cabinet dentaire | Dinan | 35800 | France |
| Cabinet dentaire | Équeurdreville-Hainneville | 50120 | France |
| Cabinet dentaire | Lamballe | 22400 | France |
| Centre de santé dentaire Chevaleret | Paris | 75013 | France |
| Centre dentaire Flandre | Paris | 75019 | France |
| Cabinet dentaire | Pluguffan | 29700 | France |
| Cabinet dentaire | Quimper | 29000 | France |
| Cabinet dentaire | Rennes | 35000 | France |
| Cabinet dentaire | Saint-Aubin-de-Médoc | 33160 | France |
| Cabinet dentaire | Tinténiac | 35190 | France |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided