NCT03874949

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: ACTEON Group · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Root Canal Obturation

Interventions

Type	Name	Description
DEVICE	SEALITE Regular	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.
DEVICE	SEALITE Ultra	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.

Timeline

• Start date: 2019-04-02
• Primary completion: 2019-08-20
• Completion: 2019-08-20
• First posted: 2019-03-14
• Last updated: 2019-09-04

Locations

1 site across 1 country: France