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

Acteon

Status

Completed

Conditions

Root Canal Obturation

Treatments

Device: SEALITE Ultra

Device: SEALITE Regular

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03874949

SEAU

Details and patient eligibility

About

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.

Enrollment

95 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.