NCT02819648

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2012

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

June 24, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 30, 2016

Completed
Last Updated

June 30, 2016

Status Verified

June 1, 2016

Enrollment Period

3.6 years

First QC Date

June 24, 2016

Last Update Submit

June 29, 2016

Conditions

Pulpitis

Keywords

symptomaticirreversible

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

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

    24 hours

  • Intake of true analgesic following endodontic treatment (Binary outcome)

    24 h

Study Arms (2)

Prednisolone

EXPERIMENTAL

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

Drug: Prednisolone

Control

PLACEBO COMPARATOR

Milk tablet administered 30 minutes before endodontic treatment

Other: Control

Interventions

PrednisoloneDRUG

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

Also known as: Glucocorticoid
Prednisolone
ControlOTHER

Milk Tablet

Also known as: Placebo
Control

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Oral & Dental Medicine

Giza, 11553, Egypt

Location

Related 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.

    PMID: 20478449RESULT

MeSH Terms

Conditions

Pulpitis

Interventions

PrednisoloneGlucocorticoids

Condition Hierarchy (Ancestors)

Dental Pulp DiseasesTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsAdrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Suzan Wanees, PhD

    Cairo Univeristy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

June 24, 2016

First Posted

June 30, 2016

Study Start

June 1, 2012

Primary Completion

January 1, 2016

Study Completion

June 1, 2016

Last Updated

June 30, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will share

Through journal publication

Locations

EG(1)