Evaluation of the effects of a period (ten sessions) of using low power laser on temporomandibular joint after maxillofacial cosmetic surgery, swelling, limitation of movement and quality of life.
Design
McGill and SF36 Persianized pain questionnaires will be completed by the patient in the first, fifth and tenth sessions. Also, the amount of pain before the start of each treatment session will be measured and recorded according to VAS. Each session before the start, the amount of swelling and the amount of range of motion of the jaw in the vertical direction will be measured and recorded.
Settings and conduct
This study will be performed in Shahid Beheshti School of Rehabilitation of Medical Sciences.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1- Patients with mandibular protrusion who underwent bilateral jaw split sagittal surgery.
2- Age range 15 to 40 years.
3- A maximum of two weeks had passed since the date of surgery.
4- Jaw movements in the direction of vertical opening were limited to less than 4 cm.
exclusion criteria: unwillingness to complete sessions and lack of patient cooperation.
Intervention groups
Intervention group: The patient will be lying down in the dental unit i. The radiation site will be considered as 5 point. To protect the patient's eyes, the patient will wear protective goggles throughout the treatment. Possible side effects of the laser will be investigated. The approximate duration of each session will be approximately 20 minutes. The number of sessions will be 10 sessions in two weeks.
Control group: using the device off and in this group the number of sessions of 10 sessions in two weeks will be considered.
Main outcome variables
the pain
Inflamation
Range of motion
Quality of Life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151128025265N4
Registration date:2021-06-23, 1400/04/02
Registration timing:prospective
Last update:2021-06-23, 1400/04/02
Update count:0
Registration date
2021-06-23, 1400/04/02
Registrant information
Name
Sedigheh Sadat Naimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7756 1411
Email address
naimi.se@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-05, 1400/08/14
Expected recruitment end date
2023-01-04, 1401/10/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of low power laser on temporomandibular joint after maxillofacial surgery
Public title
Effects of low power laser after maxillofacial surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1- Patients with mandibular protrusion who underwent bilateral jaw split sagittal surgery.
2- Age range 15 to 40 years.
3- A maximum of two weeks had passed since the date of surgery.
4- Jaw movements in the direction of vertical opening were limited to less than 4 cm.
Exclusion criteria:
unwillingness to complete sessions and lack of patient cooperation.
Age
From 15 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Patients with mandibular protrusion after cosmetic reconstructive surgery were selected by simple and available sampling and randomly divided into two groups: intervention (n: 18) and control (n: 18). In this study, for random allocation, the coin tossing method was used in such a way that one group is considered a lion and one group is considered a line and people are randomly divided into two groups according to the number of taps and lines.
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 Shahid Beheshti University of Medical Sciences
Street address
Tehran - Imam Hossein (AS) Square - Damavand St. (New Tehran) - in front of Bouali Hospital - Faculty of Rehabilitation Sciences Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1616913111
Approval date
2021-06-12, 1400/03/22
Ethics committee reference number
IR.SBMU.RETECH.REC.1400.125
Health conditions studied
1
Description of health condition studied
the effects of laser on Temporomandibular joint
ICD-10 code
M26.6
ICD-10 code description
Temporomandibular joint disorders
Primary outcomes
1
Description
Intensity of pain
Timepoint
Before and after the intervention
Method of measurement
visual analuge scale
2
Description
inflamation
Timepoint
Before and after the intervention
Method of measurement
Flexible centimeters
3
Description
Movement restrictions
Timepoint
Before and after the intervention
Method of measurement
Collis
4
Description
McGill Pain Questionnaire
Timepoint
Before and after the intervention
Method of measurement
questionnaire
5
Description
Quality of Life Questionnaire
Timepoint
Before and after the intervention
Method of measurement
Quality of Life Questionnaire SF36
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The patient was lying down in the dental unit in a state of physical and mental relaxation. The irradiation site was considered as 5 points on the operation line to reduce pain and swelling and 5 points on the joint to increase movement. The laser probe was sterilized with an alcohol swab in each session and each time it was used. The approximate duration of each session was about 20 minutes. The number of sessions was 10 sessions in two weeks
Category
Rehabilitation
2
Description
Control group: Laser device off
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Rehabilitation, Shahid Beheshti University of Medical Science
Full name of responsible person
Sedigheh Sadat Naimi
Street address
Damavand St., in front of Bouali Hospital, Shahid Beheshti Rehabilitation Faculty
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7754 8496
Email
naimi.se@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zarghi
Street address
Tehran - Shahid Chamran Highway - Yemen Street - next to Taleghani Hospital - Shahid Beheshti University of Medical Sciences
City
tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9331
Fax
+98 87 95008
Email
zarghi@sbmu.ac.ir
Web page address
https://isid.research.ac.ir/Afshin_Zarghi
Grant name
Shahid Beheshti University of Medical Science
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Dr. Afshin Zarghi
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
Sedighe Sadat Naimi
Position
associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Tehran - Imam Hossein Square - Damavand St. (New Tehran) - in front of Bouali Hospital - Faculty of Rehabilitation Sciences Shahid Beheshti University of Medical Science
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7754 8496
Email
naimi.se@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sedighe Sadat Naimi
Position
associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Tehran - Imam Hossein Square - Damavand St. (New Tehran) - in front of Bouali Hospital - Faculty of Rehabilitation Sciences Shahid Beheshti University of Medical Science
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7754 8496
Email
naimi.se@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sedighe Sadat Naimi
Position
associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Tehran - Imam Hossein Square - Damavand St. (New Tehran) - in front of Bouali Hospital - Faculty of Rehabilitation Sciences Shahid Beheshti University of Medical Science
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7754 8496
Email
naimi.se@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