Pain reduction during infiltration injection of maxillary deciduous molar teeth by low level laser in 5-9 years old children referred to pediatric ward of dentistry school of Tehran university of medical science in 2018
Design
This research is Randomized clinical trial. The sample size is 64 children between 5 to 9 years old. The randomization is done with the help of 4 numeric random blocks by Excel software.
Settings and conduct
64children between5 to 9 years old referred to pediatric ward of dental school of Tehran university of medical science will be chosen . The study is Randomized clinical trial .
Patient, care provider and information resistant will not be informed about the application of laser which is on or off.
Participants/Inclusion and exclusion criteria
Age between 5to9
Frankel's behavioral rating scale 3 or 4
Stainless steel crown (SSC) or Extraction treatment is required
No systematic problem
No psychological disorder
No lesion in intended tooth
No pain or infection history in intended tooth
No use of pain killers at least 24h before treatment
Intervention groups
In experimental group, the mucus is smeared with local anesthetic gel and then undergoes laser radiation. In control group , the situation is the same but laser device is on off mood.
Main outcome variables
Pain level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171106037264N2
Registration date:2018-09-18, 1397/06/27
Registration timing:prospective
Last update:2018-09-18, 1397/06/27
Update count:0
Registration date
2018-09-18, 1397/06/27
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
88015950 الی 54
Email address
a-bavaghar@student.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2018-12-22, 1397/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Pain reduction during infiltration injection of maxillary deciduous molar teeth by low level laser in 4-9 years old children
Public title
Pain reduction by Laser
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 5 to 9 years old
Frankel's Behavioral Rating Scale 3 or 4
SSC or Extraction treatment is required
No psychological problem
No pain or infection history in the intended tooth
No use of pain killers at least 24 h before treatment
Exclusion criteria:
Inappropriate cooperation
Systematic disease
Lesion in the intended tooth
Parents disagreement
Age
From 5 years old to 9 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
This research is randomized clinical trial.with the help of 4 numeric random blocks ,by Excel software
Blinding (investigator's opinion)
Double blinded
Blinding description
The participant, care provider,investigator and outcome assessor will not be informed about the application of laser which is on or off.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of dental school of Tehran university of medical science
Street address
North Amirabad street, front than Iran atomic energy organization .Dental school of Tehran university of medical science,Tehran
City
Tehran
Province
Tehran
Postal code
1439955991
Approval date
2018-07-11, 1397/04/20
Ethics committee reference number
IR.TUMS.DENTISTRY.REC.1397.048
Health conditions studied
1
Description of health condition studied
Pain reduction during infiltration injection of maxillary deciduous molar teeth by low level laser in children
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The pain experienced by 100 mm Visual analogue scale( 100mmVAS )
Timepoint
The pain experienced is measured right after the injection .
Method of measurement
The pain experienced is measured by 100mmVAS scale.
2
Description
Child's behavior by Modified behavioral pain scale (MBPS)
Timepoint
Child's behavior is measured during local anesthetic solution injection.
Method of measurement
Modified behavioral pain scale (MBPS)
Secondary outcomes
1
Description
Pain reduction injection
Timepoint
Right after the intervention
Method of measurement
By 100mm VAS
Intervention groups
1
Description
Intervention group: In referral session patients history will be taken and intervention's goal will be explained to parents then an informed consent will be taken.First,20% benzocaine local anesthetic gel(Brand: pahl) will be applied to the subjected area.Right after, Denlase's low level laser (wave length 810 nm, by hand piece therapy( 0/78 cross section) 200 mW power, 20 s Radiation time,5j/cm2 density of energy) will be applied to the area for 20 s before injection. This steps will be done once for buccal side and once for palatal side.
Category
Behavior
2
Description
Control group: In referral session patients history will be taken and intervention's goal will be explained to parents then an informed consent will be taken.First,20% benzocaine local anesthetic gel(Brand: pahl) will be applied to the subjected area.Right after, Denlase's low level laser, wich is on off mood will be applied to the area for 20 s before injection. This steps will be done once for buccal side and once for palatal side.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Pediatric ward of Dental school of Tehran university of medical science
Full name of responsible person
Bahman Seraj
Street address
Front than Iran atomic energy organization,North Amir abad, Dental school of Tehran university of medical science
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8801 5950
Email
dentistry@tums.ac.ir
Web page address
http://dentistry.tums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ahmad Rezaei
Street address
Front than Iran atomic energy organization , Northern Amir abad, Dental school of Tehran university of medical science
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8801 5950
Email
dentistry@tums.ac.ir
Web page address
http://dentistry.tums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Bahman Seraj
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Front than Iran Atomic Energy Organization , Northern Amirabad ,Pediatric ward of Dentistry school of Tehran university of medical science
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8801 5950
Email
serajbah@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Bahman Seraj
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Front than Iran Atomic Energy Organization , Northern Amirabad ,Pediatric ward, Dentistry school of Tehran university of medical science
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8801 5950
Email
serajbah@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Bahman Seraj
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Front than Iran Atomic Energy Organization , Northern Amirabad ,Pediatric ward, Dentistry school of Tehran university of medical science
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8801 5950
Email
serajbah@tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available