Clinical Trial: Efficacy of Oral Prednisolone on Pain Reduction in Emergency Care of Acute Irreversible Pulpitis

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Efficacy of Oral Prednisolone Versus Partial Endodontic Treatment on Pain Reduction in Emergency Care of Acute Irreversible Pulpitis of Mandibular Molars: Non Inferiority

Brief Summary: Irreversible pulpitis is an inflammatory condition of the dental pulp, highly painful, representing one of the main reasons for consulting dental emergency. The recommended emergency care is a partial endodontic treatment under local and/or locoregional anesthesia. The purpose of the emergency partial endodontic treatment is to stop the pain of pulpitis by removing a portion of the pulp. The final endodontic treatment is ideally performed 72 hours after. The literature reports major difficulty in obtaining adequate anesthesia in the mandible to perform partial endodontic treatment, especially for the mandibular molars. This results in a very painful care for the patient. The management of this type of emergency is costly in terms of equipment and time for health facilities. Patient comfort, cost saving and rationalization of the care time justify the search for an alternative to emergency partial endodontic treatment. In current practice, the short course oral corticotherapy is used in the management of oral pain from inflammatory origin. Glucocorticoids, thanks to their anti-inflammatory action, can neutralize the inflammatory mediators and thus pain. The pulp inflammation can be treated with this molecule: the effectiveness of intraosseous local steroid injection for irreversible pulpitis of mandibular molars has already been shown but results in local comorbidities and requires specific device. Oral administration of short-course prednisolone is simple and safe but its effectiveness to manage pain caused by irreversible pulpitis has not yet been demonstrated. Per-os administration of prednisolone has a very high (90%) and rapid (≤ 4 hours) bioavailability. No difference in effectiveness between intravenous and oral administration of this molecule was reported. This oral treatment could limit comorbidities and technical difficulties related to intraosseous injection and could delay the endodontic treatment to 72 hours in optimal conditions of anesthesia for

Detailed Summary:
Sponsor: University Hospital, Bordeaux

Current Primary Outcome: Pain intensity on a numeric scale [ Time Frame: 24 hours after the emergency visit (inclusion) ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The number of antalgic drugs taken after the emergency visit [ Time Frame: 72 hours after the emergency visit (inclusion) ]
  • The number of patients coming back to consultation at 72h [ Time Frame: 72 hours after the emergency visit (inclusion) ]
  • The number of injected anesthetic cartridges when performing the endodontic treatment [ Time Frame: 72 hours after the emergency visit (inclusion) ]
  • Patient's comfort evaluation during the endodontic treatment using a questionnaire with numeric scales [ Time Frame: 72 hours after the emergency visit (inclusion) ]


Original Secondary Outcome: Same as current

Information By: University Hospital, Bordeaux

Dates:
Date Received: December 7, 2015
Date Started: October 2016
Date Completion: August 2019
Last Updated: July 11, 2016
Last Verified: July 2016