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

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

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.

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.