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Completed

NCT Number: NCT02819648

Oral Glucocorticoids Effect on Post Endodontic Pain

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.

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Key information

Conditions

Pulpitis Dental Pulp Diseases Stomatognathic Diseases Tooth Diseases

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of Oral & Dental Medicine

Giza, 11553, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Prednisolone

Drug

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

Other names: Glucocorticoid

Control

Other

Milk Tablet

Other names: Placebo

Primary outcomes

  1. 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

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

    Time frame: 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.

  2. Intake of true analgesic following endodontic treatment (Binary outcome)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

The Effect of Preoperative Oral Administration of Prednisolone on Postoperative Pain in Patients With Symptomatic Irreversible Pulpitis: A Single Center Randomized Controlled Trial

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jun 30, 2016
Registry last updated
Jun 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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