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

NCT03874949 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2019-09-04

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Slb Pharma

    collaborator OTHER

  • ACTEON Group

    lead INDUSTRY

Principal Investigators

  • Hugues Colombel, MD · Private dental practice

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-02
Primary Completion
2019-08-20
Completion
2019-08-20

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03874949 on ClinicalTrials.gov