Pain After Root Canal Obturation With Sealer Containing or Not 1% Enoxolone

Study Overview
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Brief Summary
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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.

Official Title
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Comparison of Postoperative Pain After Root Canal Obturation With Sealer Containing or Not 1% Enoxolone: a Randomized Clinical Trial

Conditions
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Root Canal Obturation

Intervention / Treatment
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* Device: SEALITE Regular
* Device: SEALITE Ultra


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male or female aged from 18 to 70 years, patient requiring root canal treatment on permanent mature teeth (single rooted teeth, premolar or molar), Informed consent signed, Patient with social protection. Exclusion Criteria: root canal retreatment, root canal treatment on an immature tooth, calcified root canal assessed radiographically, Patient with one or more documented contraindication to endodontic treatment, Patient who takes regular analgesic or anti-inflammatory therapy for another pathology, Known allergy to NSAID or to one component of the sealer formula, Participation to another clinical trial at the same time, known pregnancy or lactation, Patients with legal protection.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subject will be randomized in a 1:1 allocation ratio between the two treatment groups.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SEALITE Regular<br>zinc oxide eugenol sealer | Device: SEALITE Regular<br>* 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.<br>|
| Experimental: SEALITE Ultra<br>zinc oxide eugenol sealer containing 1% Enoxolone (NSAID) | Device: SEALITE Ultra<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |