Oral Glucocorticoids Effect on Post Endodontic Pain

Phase 4CompletedNCT02819648

Cairo University400 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

400

Conditions

Pulpitis

Interventions

PrednisoloneDRUG

40 mg prednisolone (two tablets Prednisolone 20 mg, Aventis Intercontinental, Paris, France)

ControlOTHER

Milk Tablet

Eligibility

Sex: ALLMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Faculty of Oral & Dental Medicine

Giza, Egypt

Outcomes

Primary Outcomes

Degree of postoperative pain using a visual analogue scale (VAS)

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

Time frame: 24 hours

Secondary Outcomes

Intake of fake analgesic (sham) following endodontic treatment (Binary outcome)

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.

Time frame: 24 hours

Intake of true analgesic following endodontic treatment (Binary outcome)

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.

Time frame: 24 h

Data from ClinicalTrials.gov

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