Pulpitis
Conditions
Interventions
Trade Name: Solupred 20mg
Pharmaceutical Form: Tablet
INN or Proposed INN: PREDNISOLONE METASULFOBENZOATE SODIUM
CAS Number: 630-67-1
Concentration unit: mg milligram(s)
Concentration type: equal
Conc
Sponsors
CHU de Bordeaux
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants will be included if they meet the following 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 complete endodontic treatment Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 120 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 120
Exclusion criteria
Exclusion criteria: Participants will be excluded if they present at least one of the following 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), - contraindication for the prescription of glucocorticoids or codeine, - viral disease in evolution (hepatitis, herpes zoster, .. ), - machine operators , - psychosis uncontrolled by treatment, - allergy to one or more of the components, - diabetes, drug intake with direct interaction with glucocorticoids or codeine, - woman of child-bearing age without contraceptive, pregnancy, breastfeeding - not able to give informed consent, - participating in another interventional study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the trial is to compare the effect of short-course oral corticotherapy versus partial endodontic treatment for the emergency care of the irreversible pulpitis in mandibulary molars on pain 24 hours after the emergency visit.;Secondary Objective: Global assessment of care conditions using several tools: - Number of analgesic drug step 1 on the World Health Organization analgesic ladder or step 2 taken after the inclusion visit and over 72 hours - Difference in pain measured by numeric scale (NS) between the emergency visit and 24 after - Kinetics of the pain self-assessed by NS at 6, 12, 24, 48 and 72 hours after the emergency visit - Number of injected anesthetic cartridges for clinical silence for the realization of the complete endodontic treatment - Number of patients back for the complete endodontic treatment. - Patient’s comfort during the endodontic treatment measured by the scale "Iowa Satisfaction with Anesthesia Scale" (ISAS);Primary end point(s): The primary outcome is the proportion of patients with pain intensity below 5 on a numerical scale 24 hours after the emergency visit. ;Timepoint(s) of evaluation of this end point: 24 hours after the emergency visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Number of analgesic drug step 1 on the World Health Organization analgesic ladder (Paracetamol 1 gramm) or step 2 (Paracetamol 600 mg / Codeine 50mg) taken after the inclusion visit until 72 hours - Difference in pain measured by NS between T0 and T1 (24 hours after T0) - Kinetics of the pain self-assessed by NS at 6, 12, 24, 48 and 72 hours after T0 - Patient’s comfort during the complete endodontic treatment measured by the scale "Iowa Satisfaction with Anesthesia Scale" ISAS) - Number of injected anesthetic cartridges for clinical silence for the realization of the complete endodontic treatment - Number of patients back for the T2 visit. ;Timepoint(s) of evaluation of this end point: up to 72 hours after the emergency visit | — |
Countries
France
Contacts
Public ContactREC
CHU de Bordeaux
Outcome results
None listed