Oral Glucocorticoids Effect on Post Endodontic Pain

Pulpitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02819648
• Other study ID #: SCRCT1
• Status: Completed
• Phase: Phase 4
• First received: June 24, 2016
• Last updated: June 29, 2016
• Start date: June 2012
• Est. completion date: June 2016

Study information

• Verified date: June 2016
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: June 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pulpitis

Intervention

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

Other:
• Control
Milk Tablet

Locations

Country	Name	City	State
Egypt	Faculty of Oral & Dental Medicine	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Jalalzadeh SM, Mamavi A, Shahriari S, Santos FA, Pochapski MT. Effect of pretreatment prednisolone on postendodontic pain: a double-blind parallel-randomized clinical trial. J Endod. 2010 Jun;36(6):978-81. doi: 10.1016/j.joen.2010.03.015. Epub 2010 Apr 24 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	24 hours	No
Secondary	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.	24 hours	No
Secondary	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.	24 h	No