Abstract
BackgroundIrreversible 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)
Highlights
Irreversible pulpitis is a highly painful inflammatory condition of the dental pulp which represents a common dental emergency
Diagnosis of symptomatic irreversible pulpitis is based on clinical findings such as spontaneous mild to severe pain that remains after removal of the stimulus
This oral treatment could limit comorbidities and technical difficulties associated with intraosseous injection and could make it possible for complete endodontic treatment to be delayed to 72 h later in optimal conditions of analgesia for the patient
Summary
The use of short-course, orally administered corticosteroids would allow effective pain management of irreversible pulpitis in mandibular molars. Prednisolone is the referent molecule for the short-course treatment of acute and localized inflammation in both medicine generally and stomatology [18, 28] This new approach in dentistry would increase the number of complete endodontic treatments by avoiding noncompliance of patients because of pain perceived during the emergency visit and improve care and anesthesia according to recommendations of the HAS (French National Authority of Health) [29]. (DOC 121 kb) the study, the right to withdraw at any time, the Ethics Committee approval, and the personal data privacy guarantee This protocol does not present any additional risk when compared with the usual medical management of the condition.
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