Efficacy of Oral Prednisolone on Pain Reduction in Emergency Care of Acute Irreversible Pulpitis
Condition: Pulpitis
MeSH terms: Pulpitis; Emergencies
Study type: Interventional
Phase: Phase 3

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 the patient. Despite the difficulties described for the partial endodontic
      treatment, it is very effective in pain reduction and can reach 100% of success. Therefore a
      non-inferiority design was chosen to compare the effect of a short-course oral corticotherapy
      to a partial endodontic treatment for the reduction of pain at the emergency care of the
      irreversible pulpitis in mandibular molars. The intervention arm will receive an oral dose of
      prednisolone (1 mg/kg) during the emergency visit followed-up by one morning dose by day
      during three days and the reference arm will have partial endodontic treatment. Both groups
      will have planned complete endodontic treatment 72 hours after enrolment.
    


Intervention name(s): Partial endodontic treatment under local and/or locoregional anesthesia; prednisolone
Intervention type(s): Procedure; Drug
Intervention description(s): The reference management consists in local and locoregional anesthesia of the molar and partial endodontic treatment. At the end of the emergency visit, all the patients, whatever their randomization group, will be given two types of antalgics and will be recommended to take them only if they have pain. Seventy-two hours after, all the patients, whatever their randomization will have endodontic treatment under local and locoregional anesthesia.; The evaluated intervention consists in per-os administration of prednisolone (1 mg / kg) during the emergency visit followed-up by one morning dose by day during three days. At the end of the emergency visit, all the patients, whatever their randomization group, will be given two types of antalgics and will be recommended to take them only if they have pain. Seventy-two hours after, all the patients, whatever their randomization will have endodontic treatment under local and locoregional anesthesia.
Intervention MeSH terms: Prednisolone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Anesthesia; Corticosteroids; Dental Emergency; Irreversible Pulpitis; Mandibulae; Pain Management; Partial Endodontic Treatment