Evaluation of the effect of low power laser (LLLT) on pain, swelling and trismus after mandibular third molars
Design
The clinical trial is of the split mouth type and is performed as a blind strain. Randomized is a simple randomization performed on 38 patients.
Settings and conduct
This study was performed at Birjand Dental School as a bilateral surgical incision of the mandibular third molars in which the patients were blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients referred to the surgery department of Birjand Dental School are of both sexes who willingly want to remove the impacted mandibular teeth on both sides.
Exclusion criteria:
Patients with any systemic disease
Intervention groups
The intervention in this study is a low-power laser (LLLT) that is randomly given to one side of a patient's mouth.
In this study, patients are in both the control and intervention groups, with one side of the patient's mouth randomly placed in the intervention group and the other side in the control group. Laser is used in the intervention group after surgery and placebo is used in the control group after surgery.
Main outcome variables
the pain ; Inflation; Trismus
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210928052620N1
Registration date:2021-12-13, 1400/09/22
Registration timing:retrospective
Last update:2021-12-13, 1400/09/22
Update count:0
Registration date
2021-12-13, 1400/09/22
Registrant information
Name
amirmohammad chaji
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3240 6292
Email address
chajiamirmohammad@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-30, 1399/09/10
Expected recruitment end date
2021-05-26, 1400/03/05
Actual recruitment start date
2021-02-03, 1399/11/15
Actual recruitment end date
2021-09-28, 1400/07/06
Trial completion date
2021-09-28, 1400/07/06
Scientific title
Determine the effect of low level laser therapy(LLLT) on pain, swelling and trismus after impacted mandibular third molar surgery
Public title
Evaluation of The effect of low power laser (LLLT) on complications after mandibular third molars
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients of both sexes are willingly willing to remove impacted mandibular on both sides.
Patients who have the same position and inclination of the impacted molars on both sides of the mandible.
Exclusion criteria:
Patients with any systemic disease
Patients who have been taking corticosteroids for more than 3 months.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
38
More than 1 sample in each individual
Number of samples in each individual:
2
Bilateral surgery of impacted mandibular third molars
Actual sample size reached:
38
More than 1 sample in each individual
Actual sample size in each individual:
2
Bilateral surgery of impacted mandibular third molars
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization. Sealed by envelope method. We put the names of the patients in the sealed envelope and by drawing lots, the first half of the patients whose names came out of the envelope were on the right side of their mouths in the intervention group and the second half of the patients were the other way around.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, patients are blind.
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ٍEthics committee of Birjand university of medical sciences
Street address
Pamchal Blvd, pamchal 4, No.53
City
Birjand
Province
South Khorasan
Postal code
9717411143
Approval date
2021-01-09, 1399/10/20
Ethics committee reference number
IR.BUMS.REC.1399.454
Health conditions studied
1
Description of health condition studied
Bilateral surgery of impacted mandibular third molars
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The primary variable is the amount of pain based on the visual analog system (VAS), which is asked of the patient on a scale of 0 to 10.
Timepoint
Days 2 and 7 after surgery
Method of measurement
Use the VAS system to measure pain
2
Description
Another primary consequence variable is the amount of swelling, which is measured by measuring the distance from the corner of the eye to the angle of the jaw on the same side and the distance from the ear hole to the corner of the lip on the same side using a ruler or meter.
Timepoint
Days 2 and 7 after surgery
Method of measurement
Use a meter or ruler to measure inflation
3
Description
Another primary outcome variable is the amount of trismus, which measures the amount of mouth opening using a ruler or meter.
Timepoint
Days 2 and 7 after surgery
Method of measurement
Use a meter or ruler to measure the amount of trismus
Secondary outcomes
1
Description
_
Timepoint
_
Method of measurement
_
Intervention groups
1
Description
Intervention group: The intervention in this study is the use of low power laser. The type of study is split mouth in such a way that for each patient a laser (intervention) is used for one side of the wisdom tooth and a placebo is used for the opposite side. Our intervention is a low-power arsenide-gallium laser that the surgeon uses immediately after surgery and suturing the surgical site at 5 points with a power density of 52.5 joules for 30 seconds (for each point).
Category
Treatment - Other
2
Description
Control group: In our study, each person is both within the intervention group and the control group. Randomly, one side of each patient's mouth is in the intervention group and the other side is in the control group. Here, a part of the mouth that is in the control group uses a silent laser (placebo) after the surgery (the patient is blind).
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Birjand Dental School
Full name of responsible person
amirmohammad chaji
Street address
Pamchal Blvd, pamchal 4, No.53
City
Birjand
Province
South Khorasan
Postal code
9717411143
Phone
+98 56 3240 6292
Email
chajiamirmohammad@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Hamid abbaszade
Street address
Pamchal Blvd, pamchal4, N0.53
City
Birjand
Province
South Khorasan
Postal code
9717411143
Phone
+98 56 3240 6292
Email
chajiamirmohammad@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
amirmohammad chaji
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Pamchal Blvd, No.53
City
Burjand
Province
South Khorasan
Postal code
9717411143
Phone
+98 56 3240 6292
Email
chajiamirmohammad@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Amirmohammad chaji
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Pamchal Blvd, No.53
City
Birjand
Province
South Khorasan
Postal code
9717411143
Phone
+98 56 3240 6292
Email
chajiamirmohammad@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Amirmohammad chaji
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Pamchal Blvd, No.53
City
Birjand
Province
South Khorasan
Postal code
9717411143
Phone
+98 56 3240 6292
Email
chajiamirmohammad@gmail.com
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
Not applicable
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
Not applicable
Title and more details about the data/document
Information about the main outcome and patient records can be shared. Informed consent form, clinical study results, study protocol and codes used in the study are fully available.
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
Changes in initial outcomes cannot be cited in other studies because they are time-dependent. The final results of the study provide a suggestion for more detailed studies with greater scope and longer follow-up.
What processes are involved for a request to access data/document
Sending the content of the email, including the name of the researcher, the name of the study or the reason for interest, and documents related to the academic researcher, if you see the email, the documents will be sent up to one month later.