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Efficacy of Oral Prednisolone on Pain Reduction in Emergency Care of Acute Irreversible Pulpitis (PULPISOLONE)

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ClinicalTrials.gov Identifier: NCT02629042
Recruitment Status : Completed
First Posted : December 11, 2015
Last Update Posted : December 20, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

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 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.

Condition or disease Intervention/treatment Phase
Pulpitis Procedure: Partial endodontic treatment under local and/or locoregional anesthesia Drug: prednisolone Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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 Randomized Clinical Trial
Actual Study Start Date : May 15, 2017
Actual Primary Completion Date : November 28, 2018
Actual Study Completion Date : December 3, 2018


Arm Intervention/treatment
Active Comparator: Control Procedure: Partial endodontic treatment under local and/or locoregional anesthesia
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.

Experimental: Experimental Drug: prednisolone
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.




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

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


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical signs of irreversible pulpitis on a mandibular molar,
  • ASA1 or ASA2 score (American Society of Anesthesiologists)
  • Age between 18 and 70 years (of either gender)
  • Ability to give written informed consent
  • Affiliation to a health insurance scheme
  • Agreement to be contacted by phone 24h after the emergency visit
  • Availability to come back 72 hours after the emergency visit for endodontic treatment

Exclusion Criteria:

  • Diagnosis of reversible pulpitis, acute apical periodontitis, periodontal lesion of endodontic origin or dentin syndrome
  • Not retainable tooth requiring extraction
  • Contraindication of endodontic treatment (endocarditis risk) or local anaesthesia
  • Contraindication for the prescription of glucocorticoids, paracetamol or codeine,
  • Oral infection, viral disease in evolution (hepatitis, herpes zoster, .. ),
  • Machine operators ,
  • Psychosis uncontrolled by treatment, or chronic consumption of drugs or alcohol
  • Allergy to one or more of the components,
  • Diabetes, drug intake with direct interaction with glucocorticoids, paracetamol or codeine,
  • Woman of child-bearing age without contraceptive, pregnancy, breastfeeding
  • Not able to give informed consent,
  • Participating in another interventional study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02629042


Locations
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France
CHU de Bordeaux
Bordeaux, France, 33000
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
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Study Chair: Elise ARRIVE USMR, CHU de Bordeaux

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT02629042     History of Changes
Other Study ID Numbers: CHUBX 2014/09
First Posted: December 11, 2015    Key Record Dates
Last Update Posted: December 20, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Bordeaux:
Anesthesia
Corticosteroids
Dental Emergency
Irreversible Pulpitis
Mandibulae
Pain Management
Partial Endodontic Treatment

Additional relevant MeSH terms:
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Emergencies
Pulpitis
Disease Attributes
Pathologic Processes
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases
Anesthetics
Prednisolone
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents