PulpitisPhase 3PULPISOLONENCT02629042
Efficacy of Oral Prednisolone on Pain Reduction in Emergency Care of Acute Irreversible Pulpitis
A Phase 3 study testing Partial endodontic treatment under local and/or locoregional anesthesia and prednisolone in people with Pulpitis, run by University Hospital, Bordeaux at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pulpitis
- What is being tested?
- Partial endodontic treatment under local and/or locoregional anesthesia and prednisolone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteFrance
- Study dates
- 15 May 2017to 3 Dec 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 ,
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Pulpitis
- Being tested
- Partial endodontic treatment under local and/or locoregional anesthesia, prednisolone
- Keywords
- Anesthesia, Corticosteroids, Dental Emergency, Irreversible Pulpitis, Mandibulae, Pain Management, Partial Endodontic Treatment
- Medical subject headings
- Pulpitis, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partial endodontic treatment under local and/or locoregional anesthesiaProcedure or surgery
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.
prednisoloneDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Not described Receives: Procedure: Partial endodontic treatment under local and/or locoregional anesthesia |
| Experimental | Experimental | Not described Receives: Drug: prednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity on a numeric scale
Measured: 24 hours after the emergency visit (inclusion)
Secondary outcomes (4)
The number of antalgic drugs taken after the emergency visit
Measured: 72 hours after the emergency visit (inclusion)
The number of patients coming back to consultation at 72h
Measured: 72 hours after the emergency visit (inclusion)
The number of injected anesthetic cartridges when performing the endodontic treatment
Measured: 72 hours after the emergency visit (inclusion)
Patient's comfort evaluation during the endodontic treatment using a questionnaire with numeric scales
Measured: 72 hours after the emergency visit (inclusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2015 (estimated)
- Study start15 May 2017
- Primary completion28 Nov 2018
- Study completion3 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PulpitisStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elise ARRIVE, Study chair, USMR, CHU de Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02629042
- Sponsor's protocol ID
- CHUBX 2014/09
- Other IDs
- 2015-002485-24, 2015
- Acronym
- PULPISOLONE
- Status last verified
- Dec 2018
- First submitted
- 7 Dec 2015
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kerouredan O, Jallon L, Perez P, Germain C, Peli JF, Oriez D, Fricain JC, Arrive E, Devillard R. Efficacy of orally administered prednisolone versus partial endodontic treatment on pain reduction in emergency care of acute irreversible pulpitis of mandibular molars: study protocol for a randomized controlled trial. Trials. 2017 Mar 28;18(1):141. doi: 10.1186/s13063-017-1883-x.
PubMed 28351379
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02629042
- Acronym / sponsor ID
- PULPISOLONE / CHUBX 2014/09
- Conditions
- Pulpitis
- Keywords
- Anesthesia, Corticosteroids, Dental Emergency, Irreversible Pulpitis, Mandibulae, Pain Management, Partial Endodontic Treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 15 May 2017 (actual)
- Primary completion
- 28 Nov 2018 (actual)
- Study completion
- 3 Dec 2018 (actual)
- First posted
- 11 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Procedure: Partial endodontic treatment under local and/or locoregional anesthesia |
| Experimental | Experimental | Drug: prednisolone |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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, .. ),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Partial endodontic treatment under local and/or locoregional anesthesiaThe 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. | Procedure or surgery | Control |
| prednisoloneThe 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. | Drug | Experimental |
Primary outcome
Pain intensity on a numeric scale
Time frame: 24 hours after the emergency visit (inclusion)
4 secondary outcomes
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Derived from this study: PubMed 28351379Kerouredan O, Jallon L, Perez P, Germain C, Peli JF, Oriez D, Fricain JC, Arrive E, Devillard R. Efficacy of orally administered prednisolone versus partial endodontic treatment on pain reduction in emergency care of acute irreversible pulpitis of mandibular molars: study protocol for a randomized controlled trial. Trials. 2017 Mar 28;18(1):141. doi: 10.1186/s13063-017-1883-x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elise ARRIVE study chair
USMR, CHU de Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Partial endodontic treatment under local and/or locoregional anesthesia and prednisolone in people with Pulpitis, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity on a numeric scale (time frame: 24 hours after the emergency visit (inclusion)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02629042, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.