Background: Success of inferior alveolar nerve (IAN) block reduces in patients with irreversible pulpitis. The purpose of this prospective, randomized, double-blind, placebo-controlled study was to evaluate the effect of preoperative administration of alprazolam on the success of the IAN block for teeth with irreversible pulpitis.
Method: Sixty patients diagnosed with irreversible pulpitis of a mandibular molar randomly received, in a double-blind manner, identical capsules of either 0.50 mg alprazolam or placebo 45 minutes before the administration of a conventional IAN block. Access was begun 15 minutes after completion of the IAN block, and all patients had profound lip numbness. Success was defined as no or mild pain based on visual analog scale recordings during access preparation and initial instrumentation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201203032541N3
Registration date:2012-03-22, 1391/01/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-03-22, 1391/01/03
Registrant information
Name
Masoud Saatchi
Name of organization / entity
School of Dentistry, Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2822
Email address
saatchi@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2011-02-15, 1389/11/26
Expected recruitment end date
2012-02-29, 1390/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Preoperative Alprazolam on the Success of Inferior Alveolar Nerve Block for Teeth with Irreversible Pulpitis
Public title
Effect of Alprazolam on the Success of Inferior Alveolar Nerve (IAN) Block
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with active pain in a mandibular molar; prolonged response to cold testing; Absence of any periapical radiolucency on radiographs; a vital pulp while access cavity preparation; ability to understand the use of pain scales. Exclusion criteria: patients were having allergy, sensitivity, to benzodiazepines; pregnant and breast feeding patients; patients who had taken sedation within 24 hours before the treatment - having pain in more than one mandibular tooth - unable to give informed consent.
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
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
1
Registry name
ClinicalTrials.gov
Secondary trial Id
NCT01546090
Registration date
2012-03-02, 1390/12/12
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of the Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences
City
Isfahan
Postal code
81746-73461
Approval date
2011-03-15, 1389/12/24
Ethics committee reference number
390553
Health conditions studied
1
Description of health condition studied
irreversible pulpitis
ICD-10 code
K08.8
ICD-10 code description
Toothache NOS
Primary outcomes
1
Description
the success rate of the IAN block
Timepoint
1 hour after alprazolam administration
Method of measurement
Heft-Parker visual analogue scale (pain scale)
Secondary outcomes
1
Description
anxity
Timepoint
before treatment initiation
Method of measurement
Corah dental anxity scale
2
Description
initial pain
Timepoint
before alprazolam administration
Method of measurement
Heft-Parker visual analogue scale (a pain scale)
Intervention groups
1
Description
placebo, 45 minutes before the administration of a conventional IAN block
Category
Placebo
2
Description
0.50 mg of alprazolam, 45 minutes before the administration of a conventional IAN block
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Dentistry, Isfahan University of Medical Sciences
Full name of responsible person
Abbas Ali Khademi
Street address
School of Dentistry, Isfahan University of Medical Sciences
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Abbas Ali Khademi
Street address
School of Dentistry, Isfahan University of Medical Sciences
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
School of Dentistry, Isfahan University of Medical Sciences
Full name of responsible person
Abbas Ali Khademi
Position
Professor of Endodontics
Other areas of specialty/work
Street address
Department of Endodontics, School of Dentistry, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 1792 2822
Fax
Email
a_khademi@dnt.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Dentistry, Isfahan University of Medical Sciences
Full name of responsible person
Abbas Ali Khademi
Position
Professor of Endodontics
Other areas of specialty/work
Street address
Department of Endodontics, School of Dentistry, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 1792 2822
Fax
Email
a_khademi@dnt.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)