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| Name | Class |
|---|---|
| Slb Pharma | OTHER |
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This study aims to assess the efficacy of a zinc oxide eugenol sealer containing Enoxolone, a non-steroidal anti inflammatory drug (NSAID) on the pain relief after endodontic treatment.
The study design is a multicenter, doubled blinded randomized controlled trial. The comparator is the equivalent zinc oxide eugenol sealer without NSAID (allocation ratio is 1:1). The conventional endodontic treatment, using gutta percha and sealer, is done. Patients assess their pain for 7 days after permanent root obturation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SEALITE Regular | Active Comparator | zinc oxide eugenol sealer |
|
| SEALITE Ultra | Experimental | zinc oxide eugenol sealer containing 1% Enoxolone (NSAID) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SEALITE Regular | Device | Patients are treated with SEALITE Regular sealer (zinc oxide eugenol sealer). The SEALITE Regular powder is mixed with SEALITE Liquid according to the manufacturer instructions and added to gutta percha in the root canal for permanent obturation. The apical obturation is assessed by a postoperative radiographic control. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain | To assess the efficacy of Enoxolone contained in the SEALITE Ultra formula compared to the SEALITE Regular formula, the pain is assessed by patients on a diary using a Visual Analogue Scale (VAS : 0-100 mm) 24 hours after the root canal obturation. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Pain response profil | Patients reporte their pain in a diary at different times after endodontic treatment using a VAS : T0 (at the end of the surgery), 6h post-op, 12h, 24h, Day 2, Day 3, Day 7, and at any other time if necessary. The maximum pain felt is compared between the 2 groups. | 0 hour, 6 hours, 12 hours, 24 hours, Day 2, Day 3, Day 7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hugues Colombel, MD | Private dental practice | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cabinet dentaire | Rennes | 35000 | France |
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Subject will be randomized in a 1:1 allocation ratio between the two treatment groups.
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| SEALITE Ultra | Device | Patients are treated with SEALITE Ultra sealer (zinc oxide eugenol sealer containing 1% Enoxolone). The SEALITE Ultra powder is mixed with SEALITE Liquid according to the manufacturer instructions and added to gutta percha in the root canal for permanent obturation. The apical obturation is assessed by a postoperative radiographic control. |
|
| Use of oral pain treatment | Patients reporte the consumption of analgesic treatment in a diary. The proportion of patients who took oral pain medication and the treatment categories are compared between the 2 groups. | 7 days |
| Adverse events | Adverse events reported by patients on a diary from Day 0 to Day 7 and clinically observed by the dental surgeon will assess the safety and tolerability of sealers and endodontic procedures. | 7 days |