Back to resultsOral Glucocorticoids Effect on Post Endodontic Pain
Primary Purpose
Pulpitis
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Prednisolone
Control
Sponsored by
About this trial
This is an interventional treatment trial for Pulpitis focused on measuring symptomatic, irreversible
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.
Sites / Locations
- Faculty of Oral & Dental Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Prednisolone
Control
Arm Description
40 mg prednisolone (two tablets Prednisolone 20 mg, Aventis Intercontinental, Paris, France); administered 30 minutes before endodontic treatment
Milk tablet administered 30 minutes before endodontic treatment
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02819648
Brief Title
Oral Glucocorticoids Effect on Post Endodontic Pain
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulpitis
Keywords
symptomatic, irreversible
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prednisolone
Arm Type
Experimental
Arm Description
40 mg prednisolone (two tablets Prednisolone 20 mg, Aventis Intercontinental, Paris, France); administered 30 minutes before endodontic treatment
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Milk tablet administered 30 minutes before endodontic treatment
Intervention Type
Drug
Intervention Name(s)
Prednisolone
Other Intervention Name(s)
Glucocorticoid
Intervention Description
40 mg prednisolone (two tablets Prednisolone 20 mg, Aventis Intercontinental, Paris, France)
Intervention Type
Other
Intervention Name(s)
Control
Other Intervention Name(s)
Placebo
Intervention Description
Milk Tablet
Primary Outcome Measure Information:
Title
Degree of postoperative pain using a visual analogue scale (VAS)
Description
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 Outcome Measure Information:
Title
Intake of fake analgesic (sham) following endodontic treatment (Binary outcome)
Description
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
Title
Intake of true analgesic following endodontic treatment (Binary outcome)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzan Wanees, PhD
Organizational Affiliation
Cairo Univeristy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Oral & Dental Medicine
City
Giza
ZIP/Postal Code
11553
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Through journal publication
Citations:
PubMed Identifier
20478449
Citation
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.
Results Reference
result
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Oral Glucocorticoids Effect on Post Endodontic Pain
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