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

Root Canal Obturation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03874949
• Other study ID #: SEAU
• Status: Completed
• Phase: N/A
• Start date: April 2, 2019
• Est. completion date: August 20, 2019

Study information

• Verified date: September 2019
• Source: ACTEON Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: August 20, 2019
• Est. primary completion date: August 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Root Canal Obturation

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	Cabinet dentaire	Rennes

Sponsors (2)

Lead Sponsor	Collaborator
ACTEON Group	Slb Pharma

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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