The effect of premedication with oral Dexamethasone on the success of inferior alveolar nerve block for teeth with irreversible pulpitis: A double blind randomized clinical trial
Objectives; pain control during dental procedure is one of the most important goals of dentists.The most conventional method for anesthetizing mandibular molar teeth is inferior alveolar nerve block (IANB) . The aim of the present study is to assess the effect of dexamethasone (0.5 mg) administered as a single, preoperative oral dose on the success rate of IANB.
Design; in a randomized double-blinded clinical trial, 100 patients (50 per group) with irreversible pulpitis will participate in this study.
Setting and conduct; the patients who would be selected for the study will be given the placebo or 0.5 mg oral dexamethasone 1 hour before the local anesthesia. Endodontic treatments will start for the patients who reported lip numbness 15 minutes after the injection. If the patients felt an intolerable pain during the procedure, a supplementary injection will be administered. In those situations the IANB will be considered as an unsuccessful injection. The numbers of successful IANBs in two groups (placebo and dexamethasone) will be compared using Chi-square and Fisher’s exact tests.
Participants including major eligibility criteria:
Major inclusion criteria; patients with the diagnosis of symptomatic irreversible pulpitis of a posterior mandibular tooth; patients who read and sign the informed consent.
Major exclusion criteria; presence of systemic disorder; sensitivity to lidocaine or SAIDs; pregnancy; lactation; history of gastrointestinal ulcer; history of using pain medications 12 hours before the endodontic procedure.
Intervention; asking patients of first and second groups to take 0.5 mg oral dexamethasone and placebo respectively 1 hour before the local anesthesia.
Main outcome measures variables; intolerable pain.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013112515540N1
Registration date:2013-12-26, 1392/10/05
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-12-26, 1392/10/05
Registrant information
Name
Nima Moradi Majd
Name of organization / entity
Qazvin university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 1335 3061
Email address
nmoradimajd@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Qazvin school of dentistry, Qazvin university of medical sciences.
Expected recruitment start date
2014-01-01, 1392/10/11
Expected recruitment end date
2014-03-01, 1392/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of premedication with oral Dexamethasone on the success of inferior alveolar nerve block for teeth with irreversible pulpitis: A double blind randomized clinical trial
Public title
Effect of Dexamethasone on the success of local anesthesia during root canal treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Major inclusion criteria; patient with the diagnosis of symptomatic irreversible pulpitis of a posterior mandibular tooth; patients who read and sign the informed consent.
Major exclusion criteria; presence of systemic disorder; sensitivity to lidocaine or SAIDs; pregnancy; lactation; history of gastrointestinal ulcer; history of using pain medications 12 hours before the endodontic procedure.
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
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 Committee of Qazvin University of Medical Sciences
Street address
Ethics Committee of Qazvin University of Medical Sciences, faculty of nursing, Qazvin university of medical sciences, Bahonar Blvd.
City
Qazvin
Postal code
3415759811
Approval date
2013-03-18, 1391/12/28
Ethics committee reference number
28/20/8101
Health conditions studied
1
Description of health condition studied
Irreversible pulpitis
ICD-10 code
K04.0
ICD-10 code description
Diseases of pulp and periapical tissues
Primary outcomes
1
Description
Pain during root canal treatment
Timepoint
during treatment
Method of measurement
visual analogue scale (VAS), which consists of a 10-cm line anchored by 2 extremes, "no pain" and "pain as bad as it could be"
Secondary outcomes
empty
Intervention groups
1
Description
Premedication with single dose oral dexamethasone (0.5 mg), one hour before endodontic procedure.
Category
Treatment - Drugs
2
Description
Premedication with single dose placebo (dextrose gelatin capsule), one hour before endodontic procedure.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Endodontic department, Qazvin school of dentistry, Qazvin university of medical sciences
Full name of responsible person
Ali Fardnia
Street address
Endodontic department, Qazvin school of dentistry, Qazvin university of medical sciences, Bahonar Blvd.
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Qazvin School of Dentistry
Full name of responsible person
Katayoun Borhanmojabi
Street address
Qazvin school of dentistry, Qazvin University of Medical Sciences, Bahonar Blvd.
City
Qazvin
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, Qazvin School of Dentistry
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
Qazvin university of medical sciences
Full name of responsible person
Nima Moradi Majd
Position
Assistant professor
Other areas of specialty/work
Street address
Endodontic department, Qazvin school of dentistry, Qazvin university of medical sciences, Bahonar Blvd.
City
Qazvin
Postal code
3315759811
Phone
+98 28 1335 3061
Fax
Email
nimamajd@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin university of medical science
Full name of responsible person
Nima Moradi Majd
Position
Assistant professor
Other areas of specialty/work
Street address
Endodontic department, Qazvin school of dentistry, Qazvin university of medical sciences, Bahonar Blvd.
City
Qazvin
Postal code
3415759811
Phone
+98 28 1335 3061
Fax
Email
nimamajd@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Qazvin university of medical science
Full name of responsible person
Nima Moradi Majd
Position
Assistant professor
Other areas of specialty/work
Street address
Endodontic department, Qazvin school of dentistry, Qazvin university of medical sciences, Bahonar Blvd.
City
Qazvin
Postal code
3415759811
Phone
+98 28 1335 3061
Fax
Email
nimamajd@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)