Protocol summary

Summary
Injection is among dentistry a function that causes negative responses in children and hence .the reducing of injection pain due to that is one of the important problems in pediatric dentistry. The existing solution is, preparing the patient psychologically. Using some anti stress drugs and applying topical anesthesia before the injection. Topical anesthesia is one of the most important solutions before the injection. The attempt in this article compared two types of topical anesthetic agents; namely benzocaine gel (%20) and lidocaine spray (%10) in reducing the pain needle insertion in maxillary first molars palatal mucosa. Material and methods: in this clinical experimental study, 50 dental student who where physically fit and had no specific systemic diseases or drug sensitivity are select. The applicability of VAS was first are describe to every one of them and then benzocaine gel (%20) was supposedly use on the maxillary first molars palatal mucosa on one side, it use according to the manufactures instructions, needle of gauge 27 enter to the tissue .but no anesthetic agent is inject. After one minute, lidocaine spray (%10) applies to the other side of maxillary first molars palatal mucosa, it use according to its manufacturer’s instructions. The needle of gauge 27 enter to the tissue but no anesthetic agent is inject .the selected individuals announced their rate pain due to using the gel and the spray in the selected individuals announce their rate pain due to using the gel and the spray. In accordance with VAS, the data was statistically analyzed by t-student test with the safety coefficient of %95.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013030512710N1
Registration date: 2013-05-29, 1392/03/08
Registration timing: prospective

Last update:
Update count: 0
Registration date
2013-05-29, 1392/03/08
Registrant information
Name
Zeinab Jafary
Name of organization / entity
Dental Iniversity of Khorasgan
Country
Iran (Islamic Republic of)
Phone
+98 31 1778 2855
Email address
z.jafari@khuisf.ac.ir
Recruitment status
Recruitment complete
Funding source
Private
Expected recruitment start date
2013-05-30, 1392/03/09
Expected recruitment end date
2013-06-30, 1392/04/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of Benzocaine Gel(%20) and Lidocaine Spray(%10) on the Anesthesia of Maxillary First Molars Palatal Mucosa
Public title
Comparison of the Effect of gel and spray in anesthesia of palatal mucosa
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: dental student who where phisically fit and had no specific systemic diseases or drug sensevity.
Age
From 20 years old to 26 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not 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 Khorasgan Ethics Committee
Street address
Khurasgan
City
Isfahan
Postal code
Approval date
2010-09-04, 1389/06/13
Ethics committee reference number
89061307001

Health conditions studied

1

Description of health condition studied
local anesthesia
ICD-10 code
Y48.3
ICD-10 code description

Primary outcomes

1

Description
pain
Timepoint
after intrvention
Method of measurement
visual analog scale

Secondary outcomes

1

Description
patient cooperation
Timepoint
after intervention
Method of measurement
visual

Intervention groups

1

Description
use of Benzocaine Gel(%20) ,needel of gauge 27 entered to the tissue but no anasthetic agent was injected .
Category
Diagnosis

2

Description
use of Lidocaine Spray(%10) \\needel of gauge 27 entered to the tissue but no anasthetic agent was injected
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
Dental faculty of Islamic Azad University of Khorasgan
Full name of responsible person
Street address
Dental school, Islamic Azad University of Khorasgan,arghavanieh boulevard,Khorasgan ,Isfahan
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Dental Faculty of Islamic Azad University Khorasgan, Isfahan
Full name of responsible person
Lale Samadpoor
Street address
Dental school,Islamic Azad University of khorasgan,arghavanieh boulevard,Khorasgan ,Isfahan
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Dental Faculty of Islamic Azad University Khorasgan, Isfahan
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
Dental Faculty of Islamic Azad University Khorasgan, Isfahan
Full name of responsible person
Zeinab Jafary
Position
Resident of pediatric dentistry
Other areas of specialty/work
Street address
Dental school, Islamic Azad University of Khorasgan, Arghavanieh boulevard, Khorasgan, Isfahan
City
Isfahan
Postal code
Phone
+98 31 1535 4001
Fax
Email
dr_zjafary82@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Dental Faculty of Islamic Azad University Khorasgan
Full name of responsible person
Zeinab Jafary
Position
Resident of pediatric dentistry
Other areas of specialty/work
Street address
Dental school, Islamic Azad University of Kkhorasgan, Arghavanieh boulevard, Khorasgan, Isfahan
City
Isfahan
Postal code
Phone
+98 31 1535 4001
Fax
Email
dr_zjafary82@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University of Khorasgan
Full name of responsible person
Zeinab Jafary
Position
Resident of pediatric dentistry
Other areas of specialty/work
Street address
Dental school, Islamic Azad University of Khorasgan,Arghavanieh boulevard, Khorasgan, Isfahan
City
Isfahan
Postal code
Phone
+98 31 1535 4001
Fax
Email
dr_zjafary82@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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