Investigating the effect of low power diode laser on pain caused by local anesthetic injection in dentistry
Design
The clinical trial has a control group with single and double-blind randomized groups with a sample size of 30 patients. A table of random numbers will be used for randomization
Settings and conduct
The studied patients will include 30 people who refer to a private practice. After the patients enter the study, the trained assistant of the clinic, based on the table of random numbers, determines and records which side of the upper jaw (left or right) the laser or sham laser will be irradiated. Then the dentist places the laser handpiece on the left and right side of the patient's maxilla and performs the radiation .Dentist and patient do not know on which side the laser is irradiated and on which side the sham laser is irradiated. After irradiation on each side in the irradiation site, anesthesia will be injected into the maxilla with a 25 mm needle and gauge number 27 in the amount of 3.4 carpools. took Immediately after the injection of anesthesia on each side, the amount of pain and burning caused by the injection will be measured using the VAS scale.
Participants/Inclusion and exclusion criteria
Age over 18 years, having anterior teeth on both sides in the upper jaw, and the need for dental procedures that require injecting anesthesia on both sides, and the absence of pain and infection in the area
Intervention groups
Diode laser with a wavelength of 980 nm manufactured by Dr.smile company in Italy will be used. The parameters of the laser include a power of 300 milliwatts (0.3 watts), an irradiation time of 20 seconds, and an energy density of 6 joules per square centimeter
Main outcome variables
amount of pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231209060303N1
Registration date:2024-01-09, 1402/10/19
Registration timing:prospective
Last update:2024-01-09, 1402/10/19
Update count:0
Registration date
2024-01-09, 1402/10/19
Registrant information
Name
Ehsan babaei-zarch
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3521 3641
Email address
e.babaeizarch@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-10, 1402/10/20
Expected recruitment end date
2024-02-09, 1402/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of low level diode laser on the pain caused by local anesthesia in dentistry
Public title
Investigating the effect of low level diode laser on the pain caused by local anesthesia in dentistry
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years
Having front teeth on both sides in the upper jaw
The need for dental procedures will include restoration, root canal treatment and tooth extraction, which will require the injection of infiltrated anesthesia on both sides
Absence of pain and infection of the area
Exclusion criteria:
People whose age is too young (under 18) or too old and the information obtained from them is not reliable
Infectiousness of the injection site
People who are allergic to anesthetic drugs
Toothless people in the tested areas
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method in this experiment is simple and the randomization unit will be individual. In this way, the trained clinical assistant will determine by random number table which side of the jaw (left or right) each person will be lasered on and on which side the laser will be turned off. The patient and the dentist will not know which side of the laser. And they don't know which side of the off laser was irradiated, and only a trained assistant who is aware of random numbers will perform the irradiation and collect the information in a checklist.
Blinding (investigator's opinion)
Double blinded
Blinding description
The dentist and the patient do not know which side of the laser and which side of the sham laser or silent laser is irradiated because both types of lasers have the same light and sound, and both sides of the front of the patient's upper jaw require dental procedures that require It infiltrates numbness
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Yazd Faculty of Dentistry
Street address
Yazd Dahe fajr Boulevard. Yazd Faculty of Dentistry
City
Yazd
Province
Yazd
Postal code
8914815667
Approval date
2023-12-16, 1402/09/25
Ethics committee reference number
IR.SSU.DENTISTRY.REC.1402.061
Health conditions studied
1
Description of health condition studied
Comparing the effect of laser with placebo in reducing pain caused by anesthetic injection
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The amount of pain and burning caused by the injection is measured using the VAS scale. The VAS measure is a ten-centimeter segment numbered from 0 to 10. The number zero indicates no pain (there is no pain) and the number 10 means the most pain that the patient has experienced during his life.
Timepoint
Immediately after injection of anesthesia
Method of measurement
VAS criterion
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Diode laser with a wavelength of 980 nm manufactured by Dr.smile company in Italy will be used. The cross-section of the handpiece is in the form of a circle with an area of one square centimeter, which is in contact with the mucosa without putting pressure on it. The parameters of the laser include a power of 300 milliwatts (0.3 watts), an irradiation time of 20 seconds, and an energy density of 6 joules per square centimeter
Category
Other
2
Description
Control group: using a laser device; A sham laser, which has the same light, sound and appearance as a low-power diode laser, will be emitted
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Private clinic
Full name of responsible person
Ehsan Babaei zarch
Street address
Hana Alley ; Taleghani Street
City
Yazd
Province
Yazd
Postal code
8914815667
Phone
+98 913 350 6055
Email
Esi.ebz@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Amin Salehi
Street address
Fajr decade Blvd. Dental college
City
Yazd
Province
Yazd
Postal code
8914815667
Phone
+98 35 3625 0344
Email
Yazd.dent.sch@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Ehsan Babaei zarch
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Tenth Fajr Faculty of Dentistry Boulevard
City
Yazd
Province
Yazd
Postal code
8914815667
Phone
+98 913 350 6055
Email
Esi.ebz@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Ehsan Babaei zarch
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Tenth Fajr Faculty of Dentistry Blvd
City
Yazd
Province
Yazd
Postal code
8914815667
Phone
+98 913 350 6055
Email
Esi.ebz@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Ehsan Babaei zarch
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Tenth Fajr Faculty of Dentistry Blvd
City
Yazd
Province
Yazd
Postal code
8914815667
Phone
+98 35 3625 0344
Email
Yazd.dent.sch@ssu.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