Protocol summary

Summary
the aim of present study is to compare the effect of lidocaine blocks with articaine lingual infiltration as primary injection on onset and duration of anesthesia of visitors of endo-department during 2016-2017. the distinct objectives of present study are: 1-determining qualified patients and assigning them to control and test groups 2-determining onset and duration of anesthesia for these two groups the present study was conducted in the form of clinical trials.all patients with anesthetic indication in mandibular second molar with healthy pulp and two indicative quadrants were studied.their quadrants were randomly categorized into two groups of test (articaine infiltration) and control (lidocaine blocks). the injector (syringe) had identical needle tip.the test group had articaine infiltration made in ceptodent (amount:1 carpool) and control group will be regarded as next quadrant on which the same person is administered with same syringe and lidocaine block instruments (made by Daro-Pakhsh company). for both groups,after injection start of anesthesia is recorded every minutes through electric pulp tester and it is recorded in information form no.2 . in addition,duration of anesthesia , time of anesthesia ( recorded every minute) is recorded in information form no.2 in the same method until anesthesia is over.time of start and duration of anesthesia were judged in two groups through t-tests. qualified individuals without systemic and neurologic diseases and sensitivity to anesthetic drugs,smoking and alcohol and drug addiction second mandibular teeth with healthy pulp and free from infection and swelling on both sides. in the present study,30 individuals offering 60 samples were analyzed.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017020223620N6
Registration date: 2017-04-06, 1396/01/17
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-04-06, 1396/01/17
Registrant information
Name
Mohammadreza Moshari
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2595
Email address
rmoshari@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
private
Expected recruitment start date
2017-03-05, 1395/12/15
Expected recruitment end date
2018-03-06, 1396/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison the effect of lidocaine inferior alveolar nerve block versus articaine lingual infiltration as primary injection on onset and duration of pulpal anesthesia in mandibular second molar with healthy pulp
Public title
efficacy of articaine lingual infiltration on pulp anesthesia
Purpose
Health service research
Inclusion/Exclusion criteria
qualified individuals without any systemic and neurologic diseases and sensitivity to anesthetic drugs,smoking and alcohol and drug addiction second mandibular teeth with healthy pulp and free of infection and swelling on both sides
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
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
Islamic azad university,dental branch
Street address
Tehran-pasdaran st.-10th neyestan-no 4
City
Tehran
Postal code
1946853314
Approval date
2016-12-20, 1395/09/30
Ethics committee reference number
IR.IAU.DENTAL.REC.1395,18

Health conditions studied

1

Description of health condition studied
pulp
ICD-10 code
k04
ICD-10 code description
deseases of pulp and periapical tissues

Primary outcomes

1

Description
onset pulp anesthesia
Timepoint
5 minutes after injection-8 minutes after injection-11 minutes after injection-15 minutes after injection-20 minutes after injection-25 minutes after injection-30 minutes after injection-45 minutes after injection-60 minutes after injection-75 minutes after injection-90 minutes after injection
Method of measurement
in minutes

2

Description
duration of pulpal anesthesia
Timepoint
5 minutes after injection-8 minutes after injection-11 after injection-15 minutes after injection-20 minutes after injection-25 minutes after injection-30 minutes after injection-45 minutes after injection-60 minutes after injection-75 minutes after injection-90 minutes after injection
Method of measurement
in minutes

Secondary outcomes

1

Description
loss of anesthesia
Timepoint
5 minutes after injection-8 minutes after injection-11 minutes after injection-15 minutes after injection-20 minutes after injection-25 minutes after injection-30 minutes after injection-45 minutes after injection-60 minutes after injection-75 minutes after injection-90 minutes after injection
Method of measurement
in minutes

Intervention groups

1

Description
1.8 mg articaine lingual infiltration on mandibular second molar in the intervention group
Category
N/A

2

Description
1.8 mg lidocaine inferior alveolar nerve block in the control group
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Islamic azad university,dental branch
Full name of responsible person
Dr Ehsan Esnaashari
Street address
Tehran-pasdaran st.-10th neyestan-no 4
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University,Dental Branch
Full name of responsible person
Dr Arash Azizi
Street address
Tehran-Pasdaran st.-10th Neyestan-No 4
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
Dr Ehsan Esnaashari
Position
PHD
Other areas of specialty/work
Street address
Tehran-Pasdaran st.-9th Boostan-No 133
City
Tehran
Postal code
1941733113
Phone
+98 21 2279 3163
Fax
+98 21 2279 3163
Email
Ehsan_dmd@yahoo.com
Web page address
Drehsanesnaashari.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University,Dental Branch
Full name of responsible person
Dr Amir Abbas Moshari
Position
PhD
Other areas of specialty/work
Street address
Tehran-Pasdaran st.-10th Neyestan.No 4
City
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Fax
+98 21 2256 4571
Email
Ehsan_dmd@yahoo.com
Web page address
Drehsanesnaashari.ir

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad Unuversity,Dental Branch
Full name of responsible person
Shadi Mirzaei Aygani
Position
student
Other areas of specialty/work
Street address
karaj-azimie-Elham st.-no 4
City
Karaj
Postal code
3155735536
Phone
+98 26 3254 7458
Fax
Email
shadi.mirzaei91@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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