Oral Glucocorticoids Effect on Post Endodontic Pain

Phase 4

Completed

• Conditions: Pulpitis
• Interventions: Other: Control; Drug: Prednisolone

• Registration Number: NCT02819648
• Lead Sponsor: Cairo University

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

Study Timeline

• Study Start: 2012-06
• Primary Completion: 2016-01
• Status Verified: 2016-06
• Study Completion: 2016-06
• Study First Submitted: 2016-06-24
• Study First Submitted QC: 2016-06-29
• Last Update Submitted: 2016-06-29
• Study First Posted: 2016-06-30
• Last Update Posted: 2016-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	Milk tablet administered 30 minutes before endodontic treatment
Prednisolone	Prednisolone	40 mg prednisolone (two tablets Prednisolone 20 mg, Aventis Intercontinental, Paris, France); administered 30 minutes before endodontic treatment

Primary Outcome Measures

Name	Time	Method
Degree of postoperative pain using a visual analogue scale (VAS)	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 Outcome Measures

Name	Time	Method
Intake of fake analgesic (sham) following endodontic treatment (Binary outcome)	24 hours	This is a binary outcome (Intake/No intake). Each patient is given one milk tablet (sham) and instructed to use it only if patient feels post-operative pain. The aim of using a fake analgesic is to minimize the use of true analgesic which might mask the post-operative pain scoring in the first 24 hours.
Intake of true analgesic following endodontic treatment (Binary outcome)	24 h	This is a binary outcome (Intake/No intake). Each patient is given one tablet of analgesic (Diclofenac Potassium 50 mg, Novartis Pharma, Ontario, Canada). Patient is instructed to use it only if patient post-operative pain exists 2 hours following sham (fake analgesic) intake.

Trial Locations

Locations (1)

Faculty of Oral & Dental Medicine; 🇪🇬 Giza, Egypt