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

Not Applicable

Completed

• Conditions: Root Canal Obturation
• Interventions: Device: SEALITE Regular; Device: SEALITE Ultra

• Registration Number: NCT03874949
• Lead Sponsor: ACTEON Group

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-11
• Study First Submitted QC: 2019-03-13
• Study First Posted: 2019-03-14
• Study Start: 2019-04-02
• Primary Completion: 2019-08-20
• Study Completion: 2019-08-20
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-02
• Last Update Posted: 2019-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SEALITE Regular	SEALITE Regular	zinc oxide eugenol sealer
SEALITE Ultra	SEALITE Ultra	zinc oxide eugenol sealer containing 1% Enoxolone (NSAID)

Primary Outcome Measures

Name	Time	Method
Postoperative pain	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 Outcome Measures

Name	Time	Method
Adverse events	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.
Use of oral pain treatment	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.
Pain response profil	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.

Trial Locations

Locations (1)

Cabinet dentaire; 🇫🇷 Rennes, France