Skip to main content
main-content

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Trials 1/2017

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

Zeitschrift:
Trials > Ausgabe 1/2017
Autoren:
Olivia Kérourédan, Léonard Jallon, Paul Perez, Christine Germain, Jean-François Péli, Dominique Oriez, Jean-Christophe Fricain, Elise Arrivé, Raphaël Devillard
Wichtige Hinweise

Electronic supplementary material

The online version of this article (doi:10.​1186/​s13063-017-1883-x) contains supplementary material, which is available to authorized users.

Abstract

Background

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.

Methods/design

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.

Discussion

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.

Trial registration

ClinicalTrials.gov, identifier: NCT02629042. Registered on 7 December 2015.
(Version n°1.1 28 July 2015)
Zusatzmaterial
Additional file 1: Table S1. SPIRIT 2013 Checklist for PULPISOLONE. (DOC 121 kb)
13063_2017_1883_MOESM1_ESM.doc
Literatur
Über diesen Artikel

Weitere Artikel der Ausgabe 1/2017

Trials 1/2017 Zur Ausgabe