Until now there is no safe, effective, and rapid method to
eliminate the pain associated with a needle insertion
It is noticed that using a low energy laser would help rapid local
anesthesia from a lidocaine product used before intra
dermal and intra muscular . However there is not value
data evaluated effect of laser before oral injection from
benzocaine product.
Method: A prospective single-blind crossover clinical trial
was design to assess pain perception due to
needle insertion into intra mucosa in the 50 healthy
volunteer dental students . They received a topical
anesthetic agent On one side of the mucosa (control) in one minute and a
topical anesthetic agent plus low power laser on the other
side (trial) prior to the needle insertion. Dentist assessed the patients'
reaction during insertion of needle On both sides of the mucosa.
It should be noted that Left and right side randomly selected.
Inclusion criteria:Dental students volunteer.
Exclusion criteria:Any injury,Abnormalities and Dental caries,in injection site.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014111017562N2
Registration date:2015-01-06, 1393/10/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-01-06, 1393/10/16
Registrant information
Name
Soma Arabzadeh Moghadam
Name of organization / entity
Kurdestan Univercity of Medical Siences
Country
Iran (Islamic Republic of)
Phone
+98 71 3654 1094
Email address
arabzade_s@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University Of Medical Sciences
Expected recruitment start date
2014-03-01, 1392/12/10
Expected recruitment end date
2014-10-02, 1393/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of the low level laser on pain perception during needle insertion in normal mucosa in volunteer dental students.
Public title
The effect of Laser on reducing the pain associated with dental needle
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: volunteer dental students .
Exclusion criteria: Any injury, abnormalities and dental caries in injection site.
Age
From 18 years old to 25 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Science, Zand Street, Shiraz, Iran.
City
Shiraz
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
CT__P_9362_6392
Health conditions studied
1
Description of health condition studied
Local anaesthetics
ICD-10 code
Y48.3
ICD-10 code description
Local anaesthetics
Primary outcomes
1
Description
Pain associated with a needle insertion
Timepoint
Before and after laser application
Method of measurement
Visual Analog Scale
Secondary outcomes
empty
Intervention groups
1
Description
Control group : Local anesthetic gel 1 minute Before entering the needle
Category
Prevention
2
Description
Intervention group:Local anesthetic gel with laser 1 minute Before entering the needle
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Dentistry of Shiraz University of Medical Sciences
Full name of responsible person
Soma Arabzadeh Moghadam
Street address
School of Dentistry, Shiraz University of Medical Sciences, Ghasrodasht Street, Qom Abad, Shiraz, Iran.
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University Of Medical Sciences
Full name of responsible person
Basir Hashemi
Street address
Shiraz University of Medical Science, Zand Street, Shiraz, Iran.
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Soma Arabzadeh Moghadam
Position
Postgraduate student in Pediatric Dentistry
Other areas of specialty/work
Street address
Shiraz University of Medical Science, Zand Street, Shiraz, Iran.
City
Shiraz
Postal code
Phone
+98 71 3654 1094
Fax
Email
bayani_m@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Soma Arabzadeh Moghadam
Position
Postgraduate student in Pediatric Dentistry
Other areas of specialty/work
Street address
Shiraz University of Medical Science, Zand Street, Shiraz, Iran.
City
Shiraz
Postal code
Phone
+98 71 3654 1094
Fax
Email
bayani_m@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Soma Arabzadeh Moghadam
Position
Postgraduate student in Pediatric Dentistry
Other areas of specialty/work
Street address
Shiraz University of Medical Science, Zand Street, Shiraz, Iran.
City
Shiraz
Postal code
Phone
+98 71 3654 1094
Fax
Email
bayani_m@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)