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Efficacy of orally administered prednisolone versus partial endodontic treatment on pain reduction in emergency care of acute irreversible pulpitis of mandibular molars: study protocol for a randomized controlled trial

hal.structure.identifierBioingénierie tissulaire [BIOTIS]
hal.structure.identifierPôle d’Odontologie et de Santé Buccale
hal.structure.identifierUFR des Sciences Odontologiques, 33082 Bordeaux
dc.contributor.authorKÉROURÉDAN, Olivia
hal.structure.identifierPôle d’Odontologie et de Santé Buccale
hal.structure.identifierUFR des Sciences Odontologiques, 33082 Bordeaux
dc.contributor.authorJALLON, Léonard
hal.structure.identifierUnité de Soutien Méthodologique à la Recherche Clinique [USMR]
dc.contributor.authorPEREZ, Paul
hal.structure.identifierUnité de Soutien Méthodologique à la Recherche Clinique [USMR]
dc.contributor.authorGERMAIN, Christine
hal.structure.identifierPôle d’Odontologie et de Santé Buccale
hal.structure.identifierUFR des Sciences Odontologiques, 33082 Bordeaux
dc.contributor.authorPÉLI, Jean-François
hal.structure.identifierPôle d’Odontologie et de Santé Buccale
hal.structure.identifierUFR des Sciences Odontologiques, 33082 Bordeaux
dc.contributor.authorORIEZ, Dominique
hal.structure.identifierPôle d’Odontologie et de Santé Buccale
hal.structure.identifierBioingénierie tissulaire [BIOTIS]
hal.structure.identifierUFR des Sciences Odontologiques, 33082 Bordeaux
dc.contributor.authorFRICAIN, Jean-Christophe
ORCID: 0000-0001-7855-6437
hal.structure.identifierPôle d’Odontologie et de Santé Buccale
hal.structure.identifierUFR des Sciences Odontologiques, 33082 Bordeaux
hal.structure.identifierEpidémiologie et Biostatistique [Bordeaux]
dc.contributor.authorARRIVE, Elise
hal.structure.identifierPôle d’Odontologie et de Santé Buccale
hal.structure.identifierBioingénierie tissulaire [BIOTIS]
hal.structure.identifierUFR des Sciences Odontologiques, 33082 Bordeaux
dc.contributor.authorDEVILLARD, Raphael
dc.date.accessioned2021-06-10T07:05:43Z
dc.date.available2021-06-10T07:05:43Z
dc.date.issued2017-03-28
dc.identifier.issn1745-6215
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/79036
dc.description.abstractEnAbstractBackgroundIrreversible pulpitis is a highly painful inflammatory condition of the dental pulp which represents a common dental emergency. Recommended care is partial endodontic treatment. The dental literature reports major difficulties in achieving adequate analgesia to perform this emergency treatment, especially in the case of mandibular molars. In current practice, short-course, orally administered corticotherapy is used for the management of oral pain of inflammatory origin. The efficacy of intraosseous local steroid injections for irreversible pulpitis in mandibular molars has already been demonstrated but resulted in local comorbidities. Oral administration of short-course prednisolone is simple and safe but its efficacy to manage pain caused by irreversible pulpitis has not yet been demonstrated. This trial aims to evaluate the noninferiority of short-course, orally administered corticotherapy versus partial endodontic treatment for the emergency care of irreversible pulpitis in mandibular molars.Methods/designThis study is a noninferiority, open-label, randomized controlled clinical trial conducted at the Bordeaux University Hospital. One hundred and twenty subjects will be randomized in two 1:1 parallel arms: the intervention arm will receive one oral dose of prednisolone (1 mg/kg) during the emergency visit, followed by one morning dose each day for 3 days and the reference arm will receive partial endodontic treatment. Both groups will receive planned complete endodontic treatment 72 h after enrollment. The primary outcome is the proportion of patients with pain intensity below 5 on a Numeric Scale 24 h after the emergency visit. Secondary outcomes include comfort during care, the number of injected anesthetic cartridges when performing complete endodontic treatment, the number of antalgic drugs and the number of patients coming back for consultation after 72 h.DiscussionThis randomized trial will assess the ability of short-term corticotherapy to reduce pain in irreversible pulpitis as a simple and rapid alternative to partial endodontic treatment and to enable planning of endodontic treatment in optimal analgesic conditions.Trial registrationClinicalTrials.gov, identifier: NCT02629042. Registered on 7 December 2015.(Version n°1.1 28 July 2015)
dc.language.isoen
dc.publisherBioMed Central
dc.subject.enPulpotomy
dc.subject.enDental emergency
dc.subject.enIrreversible pulpitis
dc.subject.enMandibular molars
dc.subject.enPain management
dc.subject.enAnalgesia
dc.subject.enCorticosteroids
dc.title.enEfficacy of orally administered prednisolone versus partial endodontic treatment on pain reduction in emergency care of acute irreversible pulpitis of mandibular molars: study protocol for a randomized controlled trial
dc.typeArticle de revue
dc.identifier.doi10.1186/s13063-017-1883-x
dc.subject.halSciences du Vivant [q-bio]
bordeaux.journalTrials
bordeaux.page141
bordeaux.volume18
bordeaux.hal.laboratoriesBioingénierie Tissulaire (BioTis) - U1026*
bordeaux.institutionCNRS
bordeaux.institutionINSERM
bordeaux.institutionCHU de Bordeaux
bordeaux.institutionInstitut Bergonié
bordeaux.peerReviewedoui
hal.identifierinserm-01497560
hal.version1
hal.origin.linkhttps://hal.archives-ouvertes.fr//inserm-01497560v1
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