The success rate of inferior alveolar nerve block has always been discussed. The present study was aimed to investigate the effect of chlordiazepoxide and oxazepam on the success rate of mandibular block anesthesia. In this randomized double blind clinical trial study, 75 healthy adults with no consumption of medications affecting pain perception were investigated. The participants were randomly assigned into three groups, 25 participants in each group. The patients in chlordiazepoxide and oxazepam groups received 10 mg chlordiazepoxide and 10 mg oxazepam orally two hours before the nerve block, respectively. The patients in control group received placebo. Then, the inferior alveolar nerve block was performed using a cartridge containing lidocaine 2% and epinephrine 1/80,000. The success rate of IANB in 5, 15 and 30-minute periods after performing the nerve block in the second premolar and first molar in reaction to the stimuli resulting from an electric pulp tester was considered as the block success, and the pain level during the needle insertion into the soft tissue was measured by a visual analoge scale (VAS). Data were analyzed by SPSS 16 software using ANOVA, chi-square and Fisher’s exact tests.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015082717880N2
Registration date:2015-09-06, 1394/06/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-09-06, 1394/06/15
Registrant information
Name
Roohollah Sharifi
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1722 2400
Email address
r.sharifi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2015-09-01, 1394/06/10
Expected recruitment end date
2015-10-01, 1394/07/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of chlordiazepoxide and oxazepam on the success rate of mandibular nerve block anesthesia
Public title
Effect of chlordiazepoxide and oxazepam on the success rate of mandibular nerve block anesthesia
Purpose
Supportive
Inclusion/Exclusion criteria
The criteria for exclusion from the study included necrosis, pulpitis or tooth pain, mandibular orthodontic treatments, consumption of analgesics like Non-steroidal anti-inflammatory drug (NSAID( during the past two weeks, daily consumption of benzodiazepines during the past two weeks, pregnancy or breastfeeding, contraindications of chlordiazepoxide and oxazepam and consumption of drugs interfereing with chlordiazepoxide and oxazepam.
Age
From 18 years old to 45 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
75
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 Kermanshah University of Medical Sciences
Street address
Shahid Beheshti Blv.
City
Kermanshah
Postal code
Approval date
2015-02-20, 1393/12/01
Ethics committee reference number
93065، 93066
Health conditions studied
1
Description of health condition studied
Embedded and impacted teeth
ICD-10 code
KO1.1
ICD-10 code description
An impacted tooth is a tooth that has failed to erupt because of obstruction by another tooth.
Primary outcomes
1
Description
success rate of anesthesia
Timepoint
5, 15 and 30 min
Method of measurement
electric pulp tester
Secondary outcomes
1
Description
Pian level
Timepoint
During the injection
Method of measurement
visual analog scale
Intervention groups
1
Description
Intervention group :chlordiazepoxide, (10 mg)
Category
Treatment - Drugs
2
Description
Intervention group :(10 mg) oxazepam tablet.
Category
Treatment - Drugs
3
Description
control group received a capsule containing vitamin C with a glass of orange juice as placebo.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Oral and Maxillofacial Surgery Department
Full name of responsible person
Dr Hesam Nazari
Street address
Shariati St.,
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Kermanshah University of Medical Sciences
Full name of responsible person
Reza Khodarahmi
Street address
Shahid Beheshti Blv
City
Kermanshah
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 Kermanshah 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
Department of Oral and Maxillofacial Surgery, School of Dentistry, Kermanshah University of Medial S
Full name of responsible person
Hesam Nazari
Position
DDS, OMFS
Other areas of specialty/work
Street address
Shariati St
City
Kermanshah
Postal code
67139-54658
Phone
+98 83 3722 2400
Fax
Email
hesamedin_nazari@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Endodontic, School of Dentistry, Kermanshah University of Medial Sciences, Kermanshah,
Full name of responsible person
Roohollah Sharifi
Position
DDS, MS
Other areas of specialty/work
Street address
Shariati St.,
City
Kermanshah
Postal code
67139-54658
Phone
00
Fax
Email
roholahsharifi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Endodontic, School of Dentistry, Kermanshah University of Medial Sciences, Kermanshah,
Full name of responsible person
Roohollah Sharifi
Position
DDS, MS
Other areas of specialty/work
Street address
Shariati St.,
City
Kermanshah
Postal code
Phone
+98 83 3722 2400
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)