title: 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.
abstract: Irreversible 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.
  
  
  
  This 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.
  
  
  
  This 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.
  
  
  
  ClinicalTrials.gov, identifier: NCT02629042 . Registered on 7 December 2015. (Version n°1.1 28 July 2015).
authors.affiliation: CHU de Bordeaux, Pôle d'Odontologie et de Santé Buccale, 33000, Bordeaux, France.|INSERM, Bioingénierie Tissulaire, U1026, 33076, Bordeaux, France.|Université de Bordeaux, UFR des Sciences Odontologiques, 33082, Bordeaux, France.
authors.forename: Olivia
authors.initials: O
authors.lastname: Kérourédan
authors.affiliation: CHU de Bordeaux, Pôle d'Odontologie et de Santé Buccale, 33000, Bordeaux, France.|Université de Bordeaux, UFR des Sciences Odontologiques, 33082, Bordeaux, France.
authors.forename: Léonard
authors.initials: L
authors.lastname: Jallon
authors.affiliation: CHU de Bordeaux, USMR, Pôle Santé publique, 33076, Bordeaux, France.
authors.forename: Paul
authors.initials: P
authors.lastname: Perez
authors.affiliation: CHU de Bordeaux, USMR, Pôle Santé publique, 33076, Bordeaux, France.
authors.forename: Christine
authors.initials: C
authors.lastname: Germain
authors.affiliation: CHU de Bordeaux, Pôle d'Odontologie et de Santé Buccale, 33000, Bordeaux, France.|Université de Bordeaux, UFR des Sciences Odontologiques, 33082, Bordeaux, France.
authors.forename: Jean-François
authors.initials: JF
authors.lastname: Péli
authors.affiliation: CHU de Bordeaux, Pôle d'Odontologie et de Santé Buccale, 33000, Bordeaux, France.|Université de Bordeaux, UFR des Sciences Odontologiques, 33082, Bordeaux, France.
authors.forename: Dominique
authors.initials: D
authors.lastname: Oriez
authors.affiliation: CHU de Bordeaux, Pôle d'Odontologie et de Santé Buccale, 33000, Bordeaux, France.|INSERM, Bioingénierie Tissulaire, U1026, 33076, Bordeaux, France.|Université de Bordeaux, UFR des Sciences Odontologiques, 33082, Bordeaux, France.
authors.forename: Jean-Christophe
authors.initials: JC
authors.lastname: Fricain
authors.affiliation: CHU de Bordeaux, Pôle d'Odontologie et de Santé Buccale, 33000, Bordeaux, France.|Université de Bordeaux, UFR des Sciences Odontologiques, 33082, Bordeaux, France.|INSERM, ISPED, Centre INSERM U-897-Epidemiologie-Biostatistique, Bordeaux Cedex, 33076, France.
authors.forename: Elise
authors.initials: E
authors.lastname: Arrivé
authors.affiliation: CHU de Bordeaux, Pôle d'Odontologie et de Santé Buccale, 33000, Bordeaux, France. raphael.devillard@u-bordeaux.fr.|INSERM, Bioingénierie Tissulaire, U1026, 33076, Bordeaux, France. raphael.devillard@u-bordeaux.fr.|Université de Bordeaux, UFR des Sciences Odontologiques, 33082, Bordeaux, France. raphael.devillard@u-bordeaux.fr.
authors.forename: Raphaël
authors.identifier: 0000-0002-2962-2044
authors.initials: R
authors.lastname: Devillard
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002985:Clinical Protocols; D003796:Dental Service, Hospital; D004334:Drug Administration Schedule; D004632:Emergency Medical Services; D005260:Female; D005602:France; D006785:Hospitals, University; D006801:Humans; D008297:Male; D008875:Middle Aged; D008963:Molar / Q000294:innervation*; D010147:Pain Measurement; D011239:Prednisolone / Q000008:administration & dosage* / Q000009:adverse effects; D011671:Pulpitis / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D011672:Pulpotomy / Q000009:adverse effects; D012107:Research Design; D013997:Time Factors; D014098:Toothache / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000893:Anti-Inflammatory Agents; D011239:Prednisolone
keywords: Analgesia; Corticosteroids; Dental emergency; Irreversible pulpitis; Mandibular molars; Pain management; Pulpotomy