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Oral Glucocorticoids Effect on Post Endodontic Pain

NCT ID: NCT02819648

Last Updated: 2016-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2016-06-30

Brief Summary

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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

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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

Conditions

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Pulpitis

Keywords

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symptomatic irreversible

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Prednisolone

40 mg prednisolone (two tablets Prednisolone 20 mg, Aventis Intercontinental, Paris, France); administered 30 minutes before endodontic treatment

Group Type EXPERIMENTAL

Prednisolone

Intervention Type DRUG

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

Control

Milk tablet administered 30 minutes before endodontic treatment

Group Type PLACEBO_COMPARATOR

Control

Intervention Type OTHER

Milk Tablet

Interventions

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Prednisolone

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

Intervention Type DRUG

Control

Milk Tablet

Intervention Type OTHER

Other Intervention Names

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Glucocorticoid Placebo

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Elkhadem

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Suzan Wanees, PhD

Role: PRINCIPAL_INVESTIGATOR

Cairo Univeristy

Locations

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Faculty of Oral & Dental Medicine

Giza, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type RESULT
PMID: 20478449 (View on PubMed)

Other Identifiers

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SCRCT1

Identifier Type: -

Identifier Source: org_study_id