Effect of low level laser and local anesthetic gel on patient pain and discomfort during orthodontic mini screws insertion compared with local anesthesia: a clinical trial
determining the patient's pain immediately after placing the mini-screw on the infiltrating injection site
determining the patient's pain immediately after placement of mini-screw in low power laser group and local anesthesia gel according to VAS criteria
Compare the patient's pain and discomfort on both sides
Design
a split-mouth clinical trial without control group involving 25 patients
Settings and conduct
private clinic
Participants/Inclusion and exclusion criteria
patients over 18 years old undergoing fixed orthodontic treatment
patients candidate for receiving mini-screw during treatment
Intervention groups
The present study is split-mouth and the mini-screws are placed on one side using infiltrated anesthesia and on the opposite side a combination of local anesthesia gel and low power laser will be used.
Main outcome variables
Low power laser and local anesthetic gel have a better effect on controlling pain and discomfort than infiltration injection.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200616047801N1
Registration date:2020-08-11, 1399/05/21
Registration timing:registered_while_recruiting
Last update:2020-08-11, 1399/05/21
Update count:0
Registration date
2020-08-11, 1399/05/21
Registrant information
Name
Hamid Jahedsaravani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3310 3076
Email address
hamid.jahed.63@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-05, 1399/04/15
Expected recruitment end date
2020-09-05, 1399/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of low level laser and local anesthetic gel on patient pain and discomfort during orthodontic mini screws insertion compared with local anesthesia: a clinical trial
Public title
Effect of low level laser and local anesthetic gel on patient pain and discomfort during orthodontic mini screws insertion compared with local anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients over 18 years of age undergoing fixed orthodontic treatment
patients candidate for receiving a mini-screw during treatment
Exclusion criteria:
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
25
More than 1 sample in each individual
Number of samples in each individual:
2
This is a split-mouth study in which local anesthesia is used on one side and anesthesia gel and low power laser on the other side.
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
Ethics committee of Mazandaran University of Medical Sciences
Street address
khazar Blvd, Tooba dental clinic
City
Sari
Province
Mazandaran
Postal code
4816895475
Approval date
2020-07-29, 1399/05/08
Ethics committee reference number
IR.MAZUMS.REC.1399.427
Health conditions studied
1
Description of health condition studied
Evaluation of the patient's pain and discomfort during orthodontic mini-screw placement
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The amount of pain and discomfort control due to the use of local anesthesia gel and laser compared to local anesthesia without injection
Timepoint
At the beginning of the study and 12, 24 hours after inserting the mini-screw
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Injection of local anesthetic infiltration on one side which is a candidate for receiving a mini-screw
Category
Treatment - Drugs
2
Description
Intervention group: The use of local anesthesia gel and low power laser on the other side which is a candidate for a mini-screw
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Private clinic, Shahriar 3 building
Full name of responsible person
Dr farhad sobuti
Street address
shahriar3 building- Farhang Ave
City
Sari
Province
Mazandaran
Postal code
4818611894
Phone
+98 11 3332 1253
Email
Farhad_sobouti@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr farhad sobouti
Street address
Tooba dental clinic, Khazar Blvd
City
Sari
Province
Mazandaran
Postal code
4816895475
Phone
+98 11 3324 4894
Email
Farhad_sobouti@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Hamid Jahed
Position
Dental student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Tooba dental clinic, Khazar Blvd
City
Sari
Province
Mazandaran
Postal code
4816895475
Phone
+98 11 3324 4894
Fax
Email
Hamid.jahed.63@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Farhad Sobouti
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Tooba dental clinic, Khazar Blvd
City
Sari
Province
Mazandaran
Postal code
4816895475
Phone
+98 11 3324 4894
Email
Farhad_sobouti@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Hamid Jahed
Position
Dental student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Tooba dental clinic, Khazar Blvd
City
Sari
Province
Mazandaran
Postal code
4816895475
Phone
+98 11 3324 4894
Email
Hamid.jahed.63@gmail.com
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