The aim of this single blind,split mouth randomized clinical trial was to measure the heart rate changes and oxygen saturation of blood, before,immediately and 5 minutes after applying inferior alveolar and mental nerve block injections in 25 healthy patients(50 cases),aged between 18-70 years old,male or female,who referred to dental branch of Islamic Azad University,and were in need of any dental treatments of mandibular canines or premolars,at both sides.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014122220396N1
Registration date:2015-03-07, 1393/12/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-03-07, 1393/12/16
Registrant information
Name
Mehdi Vatanpour
Name of organization / entity
Islamic Azad University.Dental Branch
Country
Iran (Islamic Republic of)
Phone
+98 21 2256 4571
Email address
m_vatanpour@dentaliau.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2014-12-01, 1393/09/10
Expected recruitment end date
2015-01-31, 1393/11/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of inferior alveolar and mental nerve block on heart rate and oxygen blood saturation changes
Public title
Comparing the effect of two different dental injections on changes of heart rate and blood oxygen saturation
Purpose
Treatment
Inclusion/Exclusion criteria
Patients aged between 18 to 70 years old; patients who were in need of inferior alveolar or mental nerve block injections for extraction, restoration or endodontic treatments of mandibular canines or premolars; with the pulpal diagnosis of necrosis or irreversible pulpitis and no or mild report of pain in VAS assessment and with no systemic disease.
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
25
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Dental branch, Islamic Azad University
Street address
No.4, Neyestan 10 ave, Pasdaran street
City
Tehran
Postal code
Approval date
2014-11-30, 1393/09/09
Ethics committee reference number
د/٢٦٩/پ
Health conditions studied
1
Description of health condition studied
Heart rate & blood oxygen saturation percentage
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Heart rate
Timepoint
Before, immediately, 5 minutes after injection
Method of measurement
Puls oxymeter
Secondary outcomes
1
Description
Blood oxygen saturation
Timepoint
Before, immediately, 5 minutes after injection
Method of measurement
Puls oxymeter
Intervention groups
1
Description
Apply inferior alveolar nerve block :after aspiration,one cartridge of lidocaine 2%with epinephrine 1/80000 was injected during 60 seconds.
Category
Treatment - Drugs
2
Description
Apply Mental block injection:after aspiration,one cartridge of lidocaine2% with epinephrine was injected during 60seconds.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Islamic Azad University, Dental branch
Full name of responsible person
Mehdi vatanpour
Street address
No.4,neyestan 10 alley,pasdaran street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University, Dental branch
Full name of responsible person
Mehdi Vatanpour
Street address
Islamic Azad University, Dental branch
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University, Dental branch
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, Dental branch
Full name of responsible person
Mahnaz Mohammadian Khonsari
Position
General dentist
Other areas of specialty/work
Street address
No 4, Neyestan 10 alley, Pasdaran street
City
Tehran
Postal code
Phone
+98 21 8888 8333
Fax
Email
Mahnazmohammadian@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University, Dental branch
Full name of responsible person
Mehdi Vatanpour
Position
Associate professor/ DDS, Ms
Other areas of specialty/work
Street address
No4, Neyestan 10 alley, Pasdaran street
City
Tehran
Postal code
Phone
+98 21 8875 9644
Fax
Email
M_vatanpour@dentaliau.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University, Dental branch
Full name of responsible person
Mahnaz Mohammadian Khonsari
Position
DDs
Other areas of specialty/work
Street address
No4,neyestan 10alley,pasdaran street
City
Tehran
Postal code
Phone
+98 21 8888 8333
Fax
Email
Mahnazmohammadian@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)