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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-A00525-36 | Other Identifier | French National Agency oh Health (ANSM) |
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| Name | Class |
|---|---|
| Slb Pharma | OTHER |
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The study design is a multicentric randomized controlled clinical trial. 238 subjects (teeth) requiring a primary or a secondary root canal treatment will be enrolled in 2 groups (119 in each group).
The aim is to assess the effectiveness and utility of the ancillary drug substance, prednisolone acetate (1%) contained in CORTISOMOL SP (Zinc Oxide/Eugenol-type sealer) to help to decrease the possible postoperative painful reactions after root canal treatment. SEALITE REGULAR, which has a similar formulation except it is prednisolone acetate-free, is used as the comparator sealer.
Procedures of root canal treatment will be conventional and standardized for all investigational centers. The canals will be cleaned, shaped and then obturated using a Zinc oxide/Eugenol-type sealer (CORTISOMOL SP or SEALITE REGULAR) and gutta-percha.
Patients assess their pain for 7 days after permanent root canal obturation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CORTISOMOL SP | Experimental | Zinc oxide/Eugenol-type sealer containing 1% Prednisolone Acetate. The sealer is used in combination with gutta percha points for the permanent obturation of root canals. |
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| SEALITE REGULAR | Active Comparator | The Zinc oxide/Eugenol-type sealer is used in combination with gutta percha points for the permanent obturation of root canals. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| root canal sealer : CORTISOMOL SP | Device | The participant will be treated with CORTISOMOL SP sealer in combination with gutta percha. |
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| Measure | Description | Time Frame |
|---|---|---|
| Post-operative pain assessed by a VAS | The pain is assessed by patients in a diary using a Visual Analogue Scale (range from 0 (= no pain) to 100 (= the worst pain)) at different times after endodontic treatment from the end of the root canal obturation to 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 |
|---|---|---|
| Use of oral pain treatment | Patients reported the consumption of analgesic treatment in a diary. The proportion of patients who took oral pain medication will be compared between the 2 groups. | From the end of the root canal treatment (Day 0) to Day 7 |
| Number of adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hugues Colombel, DDS | Cabinet dentaire (Rennes) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cabinet dentaire | Lamballe | 22400 | France | |||
| Cabinet dentaire |
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Study subject (tooth) will be randomized in a 1:1 allocation ratio between the 2 treatment groups.
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the participant will be blind from the treatment
| root canal sealer : SEALITE REGULAR | Device | The participant will be treated with SEALITE REGULAR sealer in combination with gutta percha. |
|
Adverse events recorded from the endodontic treatment to the end of follow-up visit will be used to assess the safety of root canal sealers and endodontic procedures. |
| From the end of the root canal treatment (Day 0) to the end of follow-up visit (Day 14) |
| Liffré |
| 35340 |
| France |
| Cabinet dentaire | Plédran | 22960 | France |
| Cabinet dentaire | Pluguffan | 29700 | France |
| Cabinet dentaire | Rennes | 35000 | France |
| CHU Rennes - Centre de Soins Dentaires | Rennes | 35000 | France |
| Cabinet dentaire | Saint-Brieuc | 22000 | France |
| Cabinet dentaire | Saint-Coulomb | 35350 | France |