Pain After Root Canal Obturation With Sealer Containing or Not 1% Enoxolone
NCT ID: NCT03874949
Last Updated: 2019-09-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
95 participants
INTERVENTIONAL
2019-04-02
2019-08-20
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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SEALITE Regular
zinc oxide eugenol sealer
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
zinc oxide eugenol sealer containing 1% Enoxolone (NSAID)
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
70 Years
ALL
No
Sponsors
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Slb Pharma
OTHER
ACTEON Group
INDUSTRY
Responsible Party
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Principal Investigators
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Hugues Colombel, MD
Role: PRINCIPAL_INVESTIGATOR
Private dental practice
Locations
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Cabinet dentaire
Rennes, , France
Countries
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Other Identifiers
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SEAU
Identifier Type: -
Identifier Source: org_study_id
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