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

May 11, 2026 updated by: University Hospital, Bordeaux

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33000
        • CHU de Bordeaux

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Pain intensity on a numeric scale
Time Frame: 24 hours after the emergency visit (inclusion)
24 hours after the emergency visit (inclusion)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
The number of antalgic drugs taken after the emergency visit
Time Frame: 72 hours after the emergency visit (inclusion)
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)
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)
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)
72 hours after the emergency visit (inclusion)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Bordeaux

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Elise ARRIVE, USMR, CHU de Bordeaux

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 15, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 28, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 3, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 7, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 11, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CHUBX 2014/09
  • 2015-002485-24 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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