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Effect of dexamethasone as a supplemental buccal infiltration of the posterior teeth after an inferior alveolar nerve block (lidocaine 2% with 0.00001 epinephrine), on during and post treatment pain, in patients with symptomatic irreversible pulpitis

Protocol summary

Summary
aim:Effect of dexamethasone as a supplemental buccal infiltration of the posterior teeth after an inferior alveolar nerve block, on during and post treatment pain, in patients with symptomatic irreversible pulpitis, Study design: Randomized, double-blind, placebo-controlled main criteria for inclusion: a lack of medication to work, the tooth in response to cold and electrical tests have long-term positive response, radiographic signs of any the presence of radiolucent not have, exclusion criteria: pregnancy or lactation, age less than 18 years, having any kind of infectious disease or endocrine disease, allergy to dexamethasone sample size: 60 patients studied interventions: dexamethasone , normal saline, The main outcome variable: reducing pain and discomfort

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015103124798N1
Registration date: 2016-05-08, 1395/02/19
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-05-08, 1395/02/19
Registrant information
Name
Sina Shirkavand
Name of organization / entity
Islamic Azad University of Isfahan (Khorasgan), Dental School
Country
Iran (Islamic Republic of)
Phone
+98 31 3656 2350
Email address
s.shirkavand@khuisf.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2015-10-02, 1394/07/10
Expected recruitment end date
2016-02-20, 1394/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of dexamethasone as a supplemental buccal infiltration of the posterior teeth after an inferior alveolar nerve block (lidocaine 2% with 0.00001 epinephrine), on during and post treatment pain, in patients with symptomatic irreversible pulpitis
Public title
Effect of dexamethasone as a supplemental buccal infiltration of the posterior teeth after an inferior alveolar nerve block (lidocaine 2% with 0.00001 epinephrine), on during and post treatment pain, in patients with symptomatic irreversible pulpitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: lack of medication to work. Tooth in response to cold and electrical tests have long-term positive response and radiographic signs of the presence of radiolucent not have any. During vital pulp coronal access cavity preparation should be there. Exclusion criteria: pregnancy or lactation, age less than 18 years, having any kind of infectious disease or endocrine disease, moderate to advanced periodontal disease, tooth non-living, allergy to dexamethasone
Age
From 74 years old to 43 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committe of Islamic Azad University of Isfahan (Khorasgan), Dental School
Street address
Islamic Azad University of Isfahan (Khorasgan), Jay Street
City
Isfahan
Postal code
Approval date
2015-12-26, 1394/10/05
Ethics committee reference number
IR.mui.rec.1395.4.13

Health conditions studied

1

Description of health condition studied
toothache
ICD-10 code
G50-10
ICD-10 code description
atypical facial pain

Primary outcomes

1

Description
pain
Timepoint
4, 6, 12, 24, 48 hours
Method of measurement
visual analog scale (V.A.S)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention: dexamethasone(daroupakhsh co), 1 cc per injection, local injection
Category
Treatment - Drugs

2

Description
control: Normal saline (Shahid Ghazi Serum Company)
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Islamic Azad University of Isfahan (Khorasgan), Dental School
Full name of responsible person
Sina Shirkavand
Street address
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Islamic Azad University Isfahan (Khorasgan)
Full name of responsible person
ُSina Shirkavand
Street address
Islamic Azad University of Isfahan (Khorasgan), Dental School
City
Isfahan
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Islamic Azad University Isfahan (Khorasgan)
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University of Isfahan (Khorasgan), Dental School
Full name of responsible person
Sina Shirkavand
Position
endodontics/phd
Other areas of specialty/work
Street address
Islamic Azad University of Isfahan (Khorasgan), Jay Street
City
Isfahan
Postal code
Phone
+98 31 3535 4066
Fax
Email
s.shirkavand@khuisf.ac.irsinas6886@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University of Isfahan (Khorasgan), Dental School
Full name of responsible person
Sina Shirkavand
Position
Endodontics/phd
Other areas of specialty/work
Street address
Islamic Azad University of Isfahan (Khorasgan), Jay Street
City
Isfahan
Postal code
Phone
+98 31 3535 4066
Fax
Email
s.shirkavand@khuisf.ac.irsinas6886@yahoo.com
Web page address

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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