Skip to main content
OpenTrials
Completed

NCT Number: NCT03874949

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Root Canal Obturation

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cabinet dentaire

Rennes, 35000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SEALITE Regular

Device

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.

SEALITE Ultra

Device

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.

Primary outcomes

  1. Postoperative pain

    Time frame: 24 hours

    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.

Secondary outcomes

  1. Pain response profil

    Time frame: 0 hour, 6 hours, 12 hours, 24 hours, Day 2, Day 3, Day 7

    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.

  2. Use of oral pain treatment

    Time frame: 7 days

    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.

  3. Adverse events

    Time frame: 7 days

    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.

Sponsors and collaborators

Lead sponsor

ACTEON Group

Industry

Collaborators

  • Slb Pharma

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 14, 2019
Registry last updated
Sep 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.