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

NCT03874949 | Completed

• 1 other identifier: SEAU
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Postoperative pain

  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.

  24 hours

Secondary Outcomes (3)

• Pain response profil

  0 hour, 6 hours, 12 hours, 24 hours, Day 2, Day 3, Day 7

• Use of oral pain treatment

  7 days

• Adverse events

  7 days

Study Arms (2)

SEALITE Regular

ACTIVE COMPARATOR

zinc oxide eugenol sealer

Device: SEALITE Regular

SEALITE Ultra

EXPERIMENTAL

zinc oxide eugenol sealer containing 1% Enoxolone (NSAID)

Device: SEALITE Ultra

Interventions

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 Regular

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.

SEALITE Ultra

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ACTEON Group: lead
• Slb Pharma: collaborator

Study Sites (1)

Cabinet dentaire

Rennes, 35000, France

Location

Study Officials

• Hugues Colombel, MD

  Private dental practice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subject will be randomized in a 1:1 allocation ratio between the two treatment groups.

Study Record Dates

• First Submitted: March 11, 2019
• First Posted: March 14, 2019
• Study Start: April 2, 2019
• Primary Completion: August 20, 2019
• Study Completion: August 20, 2019
• Last Updated: September 4, 2019

Record last verified: 2019-09

Locations

FR (1)