Evaluation of the effect of low-level laser therapy on the healing time of trismus pain and swelling after impacted wisdom tooth extraction
Design
This study is a clinical trial study and one of the tow mandibular wisdom teeth of the patient would be intervening and another side would be the control one. This study is single-blind because the patient does not know which side is interventing or control.
Settings and conduct
It would be done in the maxillofacial surgery department of the dental school of Shahid Beheshti University of medical science. Patients are going to be informed about the study plan before surgery. The get into the study just if they accept it. we start the measurements. one side would be the placebo and the other side would be the intervention. We put the laser device on both sides of the patients' mouth, turn it on, for the intervention side, and keep it off for the placebo side.
Participants/Inclusion and exclusion criteria
All patients whoever aged between 18-30 years and have mandibular third molar symmetric impacted teeth are included in the study. Pregnancy; breastfeeding; smoking; any systemic or neurological disease; pericoronitis and laser therapy contraindications are not included in the study.
Intervention groups
In this study, a patient is in the intervening group in one side surgery and in the control group in the surgery of another side. The patient receives common medication in both surgeries. For intervention, we use low-level laser and LED on one side and the placebo on the other side as the control group.
Main outcome variables
We expect that this intervention affects the trismus, pain, and swelling after impacted mandibular wisdom tooth extraction.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180608040005N1
Registration date:2020-05-04, 1399/02/15
Registration timing:retrospective
Last update:2020-05-04, 1399/02/15
Update count:0
Registration date
2020-05-04, 1399/02/15
Registrant information
Name
Ghazale Keyvani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6635 0274
Email address
keyvani.ghazaleh@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-15, 1398/03/25
Expected recruitment end date
2019-07-11, 1398/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The evaluation of effects of low-level laser on the healing of trismus, pain and swelling after mandibular impacted wisdom tooth extraction
Public title
The evaluation of effects of low-level laser on the healing of trismus, pain and swelling after mandibular impacted wisdom tooth extraction
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Whoever aged between 18-30 years old and has symmetric mandibular wisdom tooth which is candidate for surgical extraction
Exclusion criteria:
Not symmetric wisdom teeth
Patient has any systemic or neurological disease
Laser therapy contraindication
Pulp involvment
Smoking
Pregnancy
Breast feeding
Pericoronitis
Age
From 18 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
80
More than 1 sample in each individual
Number of samples in each individual:
2
Both wisdom teeth
Randomization (investigator's opinion)
Randomized
Randomization description
Simple
Blinding (investigator's opinion)
Single blinded
Blinding description
The patient does not know which side would be placebo or the laser.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee Shahid Beheshti University Of Medical Science
Street address
Dental School, Daneshjoo Blvd. Chamran Expy. Tehran
City
Tehran
Province
Tehran
Postal code
1983963113
Approval date
2017-08-01, 1396/05/10
Ethics committee reference number
IR.SBMU.RIDS.REC.1396.502
Health conditions studied
1
Description of health condition studied
Pain, trismus and swelling after mandibular impacted wisdom tooth extraction
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Trismus, pain and swelling would be measured before and after surgery
Timepoint
Before surgery, 3 days later, 7 days later
Method of measurement
For Pain the VAS system, for trismus a calipers, and a bending ruler for swelling
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this study the intervention is taking low-level laser right after surgery in 3 points. occlusal, buccal and one from out of the mouth, on the surgery spot.
Category
Treatment - Devices
2
Description
Control group: Patients take non-working Laser as plasebo on the same three locations mentioned before
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental School Of Shahid Beheshti University Of Medical Science
Full name of responsible person
Ghazale Keyvani
Street address
Daneshjoo Blvd.
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2217 5351
Email
keyvani.ghazaleh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ghazale Keyvani
Street address
Daneshjoo Blvd.
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2217 5351
Email
keyvani.ghazaleh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ghazaleh Keyvani
Position
Dentistry student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Shahid Beheshti Dental school, Daneshjoo St. Chamran Exp.
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 6635 0274
Email
keyvani.ghazale@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ghazale Keyvani
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Dental school of Shahid Beheshti Universiti of Medical Science, Daneshjoo Blvd, Velenjak
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 6635 0274
Fax
Email
Keyvani.ghazaleh@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ghazale Keyvani
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Dental school of Shahid Beheshti Universiti of Medical Science, Daneshjoo Blvd, Velenjak
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 6635 0274
Fax
Email
Keyvani.ghazaleh@sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The collected and measured data can be shared for authorized executives and organizations
When the data will become available and for how long
One year after publication
To whom data/document is available
Data will be shared for people working in academic institutions
Under which criteria data/document could be used
Using for academic studies
From where data/document is obtainable
By E-mail
What processes are involved for a request to access data/document
After evaluating the reasons for asking for data, you will be answered in one month