Effectiveness of oral prednisolone versus partial endodontic treatment on pain reduction in emergency care of acute irreversible pulpitis of mandibular molars: study protocol for a non inferiority randomized clinical trial.

Phase 1

• Conditions: Pulpitis; Therapeutic area: Diseases [C] - Mouth and tooth diseases [C07]

• Registration Number: EUCTR2015-002485-24-FR
• Lead Sponsor: CHU de Bordeaux

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-06-24
• Last Update Posted: 8 June 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified