The Effect of Preoperative Oral Administration of Prednisolone on Postoperative Pain in Patients With Symptomatic Irreversible Pulpitis: A Single Center Randomized Controlled Trial
Overview
- Phase
- Phase 4
- Intervention
- Prednisolone
- Conditions
- Pulpitis
- Sponsor
- Cairo University
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- Degree of postoperative pain using a visual analogue scale (VAS)
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
The aim of this single-center randomized, double-blind, placebo-controlled clinical trial is to assess the effect of preoperative, single, oral dose of prednisolone on postoperative pain and medication intake in patients with symptomatic, irreversible pulpitis in mandibular molars.
Detailed Description
Patients receive 40 mg prednisolone (two tablets Prednisolone 20 mg, Aventis Intercontinental, Paris, France); and group B (Control), where patients received two placebo tablets. All patients receive the assigned premedication 30 minutes before the administration of local anesthesia
Investigators
Ahmed Elkhadem
Lecturer
Cairo University
Eligibility Criteria
Inclusion Criteria
- •Systemically healthy patients, aged between 18-35 years, with mandibular molars with symptomatic irreversible pulpitis, radiographically-normal periapical area and no pain on biting or percussion.
Exclusion Criteria
- •Pregnant patients, patients with any known sensitivity or adverse reactions to any of the medications or materials used in this study, those who had used any analgesic medication during the preceding 6 hours before the treatment, those with unrestorable teeth or teeth with severe periodontal disease. Patients with active sites of pathosis in the area of injection were, also, excluded.
Arms & Interventions
Prednisolone
40 mg prednisolone (two tablets Prednisolone 20 mg, Aventis Intercontinental, Paris, France); administered 30 minutes before endodontic treatment
Intervention: Prednisolone
Control
Milk tablet administered 30 minutes before endodontic treatment
Intervention: Control
Outcomes
Primary Outcomes
Degree of postoperative pain using a visual analogue scale (VAS)
Time Frame: 24 hours
Measured using visual analogue scale (VAS). It is a 10 points scale from 0 to 10, where zero expresses no pain and 10 expresses severe pain
Secondary Outcomes
- Intake of fake analgesic (sham) following endodontic treatment (Binary outcome)(24 hours)
- Intake of true analgesic following endodontic treatment (Binary outcome)(24 h)