A comparative onset and duration of anesthetic of articaine 4% with epinephrine 1:100000 and lidocaine 2% with epinephrine 1:80000 with AMSA nerve block in anterior and premolar teeth
The aim of this Randomized, Double blind, Cross over clinical trial is comparing the onset and duration of anesthetic effect of Anterior Middle Superior Alveolar (AMSA) nerve block using Articaine 4% with epinephrine 1:100000 and Lidocaine 2% with epinephrine 1:80000 in anterior and premolar teeth. Sixteen male/female volunteers ranging 18 to 65 years old which have at least 3 intact incisors, canine and premolars in each quadrant, including the study. The base line sensitivity of each tooth will determine by electric and cold tests. In first session, the AMSA block will perform by 0.9 ml Lidocaine and after one week the block will repeat by the same volume of Articaine. The onset of anesthesia will consider where both the electric and cold tests respond negatively and every one minute the tests will continue till the positive response to one of the the test regain, and the time will consider for the end of anesthesia.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017041815782N5
Registration date:2017-07-17, 1396/04/26
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-07-17, 1396/04/26
Registrant information
Name
Peyman Mehrvarzfar
Name of organization / entity
Tehran Medical Science Branch, Islamic Azad University
Country
Iran (Islamic Republic of)
Phone
+98 21 8875 9644
Email address
p_mehrvarzfar@dentaliau.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2017-12-21, 1396/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative onset and duration of anesthetic of articaine 4% with epinephrine 1:100000 and lidocaine 2% with epinephrine 1:80000 with AMSA nerve block in anterior and premolar teeth
Public title
A comparative effiicacy of two anesthetics in teeth anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients between 18 and 65 years; patients with minimum one healthy tooth quadrant
Exclusion criteria: allergy to local anesthetic agents; history of systemic disease; pregnancy and lactation; take any CNS depressants including alcohol or any analgesic medication within the last 24 h; have pulp and preapical disease; using tobacco products
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
16
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ٍٍEthics Committee of Tehran Medical Science Branch, Islamic Azad University
Street address
No.4, Neyestan 10 Alley, Pasdaran Street
City
Tehran
Postal code
Approval date
2017-03-12, 1395/12/22
Ethics committee reference number
د/113/پ
Health conditions studied
1
Description of health condition studied
local anesthesia
ICD-10 code
Y48.3
ICD-10 code description
Local anaesthetics
Primary outcomes
1
Description
duration of anesthesia
Timepoint
in one minutes
Method of measurement
minute-hand clock
2
Description
onset of anesthesia
Timepoint
in one minutes after injection
Method of measurement
minute-hand clock
Secondary outcomes
empty
Intervention groups
1
Description
Injection of 0.9 ml Lidocaine 2% with epinephrine 1:80000 with AMSA technique in 60 seconds.
Category
Treatment - Drugs
2
Description
Injection of 0.9 ml Articaine 4% with epinephrine 1:100000 with AMSA technique in 60 seconds.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Medical science Branch,Islamic Azad University
Full name of responsible person
Sohrab Tour Savadkouhi
Street address
No.4, Neyestan10 Alley, Pasdaran Street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran Medical Science Branch, Islamic Azad University
Full name of responsible person
Nava VakiliNejad
Street address
No.4, Neyestan10 Alley, Pasdaran Street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran Medical Science Branch, Islamic Azad University
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
Tehran Medical Science Branch, Islamic Azad University
Full name of responsible person
Peyman Mehrvarzfar
Position
Associate Professor/ DDS,Ms
Other areas of specialty/work
Street address
No.4, Neyestan10 Alley, Pasdaran Street
City
Tehran
Postal code
19585175
Phone
+98 21 8875 9644
Fax
Email
P_mehrvarzfar@dentaliau.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran Medical Science Branch, Islamic Azad University
Full name of responsible person
Sohrab Tour Savadkouhi
Position
Associate Professor/ DDS,Ms
Other areas of specialty/work
Street address
No.4, Neyestan10 Alley, Pasdaran Street
City
Tehran
Postal code
19585175
Phone
+98 21 2613 0156
Fax
Email
s_savadkouhi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran Medical Science Branch, Islamic Azad University
Full name of responsible person
Peyman Mehrvarzfar
Position
Associate Professor/ DDS,Ms
Other areas of specialty/work
Street address
No.4, Neyestan10 Alley, Pasdaran Street
City
Tehran
Postal code
19585175
Phone
+98 21 8875 9644
Fax
Email
P_mehrvarzfar@dentaliau.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)