Protocol summary

Summary
Aim of this study is comparision the effect of premedication with Acifen and Dexamethasone on the success of inferior alveular nerve block for first and second molar teeth of mandible with symptomatic irreversible pulpitis. Inclusion criteria: patient with first or second molar teeth of mandible with symptomatic irreversible pulpitis, non systematic disease, non allergic patient to Lidocaine with 1:80000 Epinephrine, non allergic patient to NSAIDs, non allergic patient to Caffeine, non periapical radiolucency, non analgesic drug consumption 12 hours before treatment, non tooth with full crown Exclusion criteria: non numles of lower lip, partial necrose of tooth In this randomize double blind clinical trial study population are patients will be refer to General Endodontic Department of Dentistry School of Qazvin University of Medical Science of Iran. The patients will be divide into 3 groups and random assignment.Patients will receive randomly one identical capsules contain .5 mg demamethasone or acifen or placebo 45 minutes before administration of a conventional IAN block.Access will begin 15 minutes after complation of IAN block for patient with lower lip numbness.success will define as no or mild pain according to visual analogue scale recordings on access cavity Sample size: 150

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014082618941N1
Registration date: 2014-10-25, 1393/08/03
Registration timing: prospective

Last update:
Update count: 0
Registration date
2014-10-25, 1393/08/03
Registrant information
Name
Ehsan Kamani
Name of organization / entity
University
Country
Iran (Islamic Republic of)
Phone
+98 28 3367 7908
Email address
ekamani@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
General Endodontic Department of Dentistry School of Qazvin University Medical Science of Iran
Expected recruitment start date
2014-11-01, 1393/08/10
Expected recruitment end date
2014-12-31, 1393/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparision The effect of premedication with Acifen and Dexamethasone on the success of inferior alveolar nerve block for first and second molar teeth with symptomatic irreversible pulpitis
Public title
Comparision The effect of premedication with Acifen and Dexamethasone on the success of mandible nerve block in first and second molar teeth of mandible with symptomatic irreversible pulpitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patient with first or second molar teeth of mandible with symptomatic irreversible pulpitis, non systematic disease, non allergic patient to Lidocaine with 1:80000 Epinephrine, non allergic patient to NSAIDs, non allergic patient to Caffeine, non periapical radiolucency, non analgesic drug consumption 12 hours before treatment, non tooth with full crown Exclusion criteria: non numles of lower lip, partial necrose of tooth
Age
From 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 150
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
Dentistry School of Qazvin University of Medical Science
Street address
University of Medical Science, Shahid Bahonar st
City
Qazvin
Postal code
Approval date
2014-09-15, 1393/06/24
Ethics committee reference number
28/20/9176

Health conditions studied

1

Description of health condition studied
Irrevesible pulpitis
ICD-10 code
K04.0
ICD-10 code description
Pulpitis

Primary outcomes

1

Description
Pain
Timepoint
45 minutse before access cavity preparation and during access cavity preparation
Method of measurement
visual analog scale

Secondary outcomes

empty

Intervention groups

1

Description
Dexamethasone group: .5 mg oral dexamethasone 30 minute before injection
Category
Treatment - Drugs

2

Description
Acifen group: Acifen capsul contain 200 mg Iboprofen , 325 mg Acetaminophen, 40mg cofein 30 minute befor injection
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
General Endodontics Department of Dentistry School of Qazvin University Medical Science
Full name of responsible person
Ehsan kamani
Street address
Bahonar St, Qazvin University of Medical Scinces
City
Qazvin

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Fateme Sefidi
Street address
bahonar st University of Medical Sciences, Dentistry School
City
qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin University of Medical Sciences
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
University of Medical Science
Full name of responsible person
فاطمه سفیدی
Position
Reserch chief
Other areas of specialty/work
Street address
Dentistry School of Qazvin University of Medical Sciences
City
Qazvin
Postal code
Phone
+98 28 3335 3061
Fax
Email
Fssfateme@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
university of medical science
Full name of responsible person
Ehsan Kamani
Position
doctor of dental surgery
Other areas of specialty/work
Street address
shaid jafari alley, shahid sadughi st
City
khomein
Postal code
Phone
+98 86 6433 9229
Fax
Email
ehsan.kamani67@gmail.comehsandrkamani@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
Position
Other areas of specialty/work
Street address
City
Postal code
388197481
Phone
+98 86 4633 9229
Fax
Email
ehsan.kamani@gmail.com
Web page address

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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