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

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.

Study Overview

• Status: Completed
• Conditions: Root Canal Obturation
• Intervention / Treatment: Device: SEALITE Regular; Device: SEALITE Ultra

• Study Type: Interventional
• Enrollment (Actual): 95
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rennes, France, 35000
    • Cabinet dentaire

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: SEALITE Regular; zinc oxide eugenol sealer	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.
Experimental: SEALITE Ultra; zinc oxide eugenol sealer containing 1% Enoxolone (NSAID)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain response profil	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.	0 hour, 6 hours, 12 hours, 24 hours, Day 2, Day 3, Day 7
Use of oral pain treatment	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.	7 days
Adverse events	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.	7 days

Collaborators and Investigators

• Sponsor: ACTEON Group
• Collaborators: Slb Pharma
• Investigators: Principal Investigator: Hugues Colombel, MD, Private dental practice

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2019
• Primary Completion (Actual): August 20, 2019
• Study Completion (Actual): August 20, 2019

Study Registration Dates

• First Submitted: March 11, 2019
• First Submitted That Met QC Criteria: March 13, 2019
• First Posted (Actual): March 14, 2019

Study Record Updates

• Last Update Posted (Actual): September 4, 2019
• Last Update Submitted That Met QC Criteria: September 2, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: SEAU

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No