Root Canal Obturation
Conditions
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.
Interventions
DEVICESEALITE 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.
DEVICESEALITE 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.
Sponsors
Slb Pharma
ACTEON Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Subject will be randomized in a 1:1 allocation ratio between the two treatment groups.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Countries
France
Outcome results
None listed