Protocol summary

Summary
In this study, the anesthetic efficacy of articaine infiltration technique with lidocaine inferaalveolar nerve block technique in pulp therapy of lower primary molars is compared. This article is a randomized, triple-blind crossover study without control and placebo and the study group is four to ten years old healthy children who need bilateral lower primary molar pulp therapy or deep restoration. Among these, children who have good cooperation are included, but children who do not cooperate are excluded and For this purpose, 64 children are enrolled in the study. Children are randomly and equally devided into two groups, A and B and they are treated within two sessions and in each session, one lower primary molar pulp therapy is done. Group A, in first session receives lidocaine infraalveolar nerve block injection and in second session receives articaine infiltrarion injection. In group B, all the procedure is the same as group A, but this group in first session receives articaine infiltrarion injection and in second session receives lidocaine infraalveolar nerve block injection. Also the washout period is one week. In each session, at the moment of pulp exposure, the child will be asked to mark visual analuge scale according to his pain. If the anesthesia caused by articaine infiltrarion injection is equal or better than lidocaine infraalveolar nerve block injection, due to greater ease and lesser risk, it can be the choice injection in pulp therapy of lower primary molars.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016102830448N2
Registration date: 2016-11-14, 1395/08/24
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-11-14, 1395/08/24
Registrant information
Name
Foad Iranmanesh
Name of organization / entity
Rafsanjan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3428 0034
Email address
foad.iranmanesh@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Rafsanjan University of Medical Sciences
Expected recruitment start date
2016-11-21, 1395/09/01
Expected recruitment end date
2017-01-19, 1395/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the anesthetic efficacy of articaine infiltration versus lidocaine inferior alveolar nerve block in pulp therapy of lower primary molars
Public title
Comparison of the anesthetic efficacy of two techniques in pulp therapy of lower primary molars
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion: 4-10 years old children who are healthy and have good coopration and need bilateral lower primary molar pulp therapy or deep restorations. Exclusion: Children who do not cooperate or have a history of medical problems for local anesthesia or have a wound or mucousal lesions in the buccal vestibule
Age
From 4 years old to 10 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 64
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Rafsanjan University of Medical Scienses
Street address
Dental school,west Mofateh avenue
City
Rafsanjan
Postal code
Approval date
2016-10-24, 1395/08/03
Ethics committee reference number
ir.rums.rec.1395.76

Health conditions studied

1

Description of health condition studied
Local anaesthesia
ICD-10 code
Y48.3
ICD-10 code description
Local anaesthetics

Primary outcomes

1

Description
pain
Timepoint
one week
Method of measurement
visual analuge scale

Secondary outcomes

empty

Intervention groups

1

Description
Articaine , infiltration, 4% , injection
Category
Treatment - Drugs

2

Description
lidocaine , infraalveolar nerve block injection , 2 % , injection
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Dental school of Rafsanjan
Full name of responsible person
Dr Maryam Sharifi
Street address
West Mofateh avenue
City
Rafsanjan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr Maryam Sharifi
Street address
West Mofataeh avenue
City
Rafsanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr Maryam Sharifi
Position
Assistant Professor\PHD
Other areas of specialty/work
Street address
west Mofateh avenue
City
Rafsanjan
Postal code
Phone
+98 34 3428 0031
Fax
+98 34 3428 0008
Email
maryam_sharifi_79@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr Maryam Sharifi
Position
Assistant Professor\PHD
Other areas of specialty/work
Street address
west Mofateh avenue
City
Rrafsanjan
Postal code
Phone
+98 34 3428 0031
Fax
+98 34 3428 0008
Email
maryam_sharifi_79@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr Foad Iranmanesh
Position
Assistant Professor\PHD
Other areas of specialty/work
Street address
west Mofateh avenue
City
Rafsanjan
Postal code
Phone
+98 34 3428 0031
Fax
+98 34 3428 0008
Email
foad.iranmanesh@iran.ir
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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