Evaluation of the Effectiveness of Low Level Laser Therapy (LLLT) on the Location of Radiation to Masticatory Muscles and TMJ Masticatory Muscles in the Treatment of TMD Patients
The Aim of This Study is to Investigate The Short-term and Long-term Therapeutic Effects of Low Level Laser along with The Use of Digital Occlusal Splints in the Treatment of TMD Patients.
Design
A Concealed, Randomized, Unblinded, Sham Controlled Clinical Trial With Two Parallel Groups design among 30 Patients. The rand function of Excel software was used for randomization.
Settings and conduct
The place of the study: Department of Dental Prostheses; Shahid Beheshti Dental School,Tehran; Population: TMD patients; Blinding: blinding was not done in this study.
Participants/Inclusion and exclusion criteria
Inclusions Criteria:
Age of Patients Between 20 and 50 years; Diagnosis of TMD based on DC / TMD and RDC / TMD criteria)
Exclusion Criteria:
History of Recent Facial Trauma;
Congenital or Developmental Disorders of The Jaw; History or Presence of Systemic Musculoskeletal Diseases;
History or Presence of Cancer;
Pregnancy;
History of Previous Treatment of TMD During The Last Month;
using Complete Dentures
Intervention groups
Intervention group 1: Low Level diode Laser Treatment; 12 Sessions; In 10 Points of The Masticatory Muscles For 10 Seconds in Each Point Bilaterally. Then Using The Digital Occlusal Splint for three months.
Intervention group 2: Low Level diode Laser Treatment; 12 Sessions; In 18 Points of The Masticatory Muscles And TMJ For 10 Seconds in Each Point Bilaterally. Then Using The Digital Occlusal Splint for Three Months.
Control group: Under The Same Conditions As The Laser Treatment Group, Only The Red Light And Laser Warning Sound Will be Used for 12 Sessions. Then Using The Digital Occlusal Splint for three months.
Main outcome variables
Spontaneous Pain; Pain During Function; Limited Range of Jaw Movements
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220613055160N1
Registration date:2022-07-11, 1401/04/20
Registration timing:prospective
Last update:2022-07-11, 1401/04/20
Update count:0
Registration date
2022-07-11, 1401/04/20
Registrant information
Name
Leili Habibi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2217 5351
Email address
habibileila1366@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-23, 1401/06/01
Expected recruitment end date
2022-11-22, 1401/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effectiveness of Low Level Laser Therapy (LLLT) on the Location of Radiation to Masticatory Muscles and TMJ Masticatory Muscles in the Treatment of TMD Patients
Public title
Using Low Level Laser in The Treatment of The TMD patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 20 and 50 years
Diagnosis of TMD based on DC / TMD and RDC / TMJ criteria)
Click problems, limitation in maximum mouth opening and chronic orofacial pain more than three months
Exclusion criteria:
History of Recent Trauma to The Face
Congenital or Developmental Disorders of The Jaw
History of Recent facial Bone Fractures
History or Presence of Systemic Musculoskeletal Diseases
History or Current Cancer
History or Presence of Skin Lesions at The Laser Site
Pregnancy
History of Previous TMD Treatment
History or Presence of Mental Disorders
Complete Dentures Patients
Presence of Toothache or Periodontal Lesions
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
The Rand Function of Excel Software was used for Randomization. The Allocation of Patients to 3 Treatment Groups is done in the form of Randomized Blocks. So that 5 Blocks of 6 are defined, and in Each of These Blocks, the Order of Treatments is generated randomly with the Excel Program. Patients receive Random Treatment in These Randomized Blocks in the Order of Referral.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Research of Dental School of Shahid Beheshti University of Medical Science
Street address
Shahid Beheshti Dental School; Shahid Beheshti University of Medical Sciences; Evin Blvd.
City
Tehran
Province
Tehran
Postal code
1983969411
Approval date
2022-07-02, 1401/04/11
Ethics committee reference number
IR.SBMU.DRC.REC.1401.024
Health conditions studied
1
Description of health condition studied
Temporomandibular disorder
ICD-10 code
M26.6
ICD-10 code description
Temporomandibular joint disorders
Primary outcomes
1
Description
Intensity of spontaneous pain
Timepoint
Spontaneous Pain Measurement before the Study, 30 Days after the Completion of the Laser Therapy Period; 30 and 90 Days after Using the Digital Occlusal Splint
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Pain Intensity During function
Timepoint
Measurement of Pain During Function before the Study, 30 Days after the Completion of the Laser Treatment Period; 30 and 90 Days after Using Digital Occlusal Splint.
Method of measurement
Visual Analogue Scale
2
Description
Maximum Mouth Opening
Timepoint
Measurement of the Maximum Mouth Opening before the Study, 30 Days after the Completion of the Laser Treatment Period; 30 and 90 Days after Using Digital Occlusal Splint.
Method of measurement
Using a Ruler in millimeter Scale
3
Description
Mandibular Lateral Movements
Timepoint
Measurement of the Mandibular Lateral Movement before the Study, 30 Days after the Completion of the Laser Treatment Period; 30 and 90 Days after Using Digital Occlusal Splint.
Method of measurement
Using a Periodontal Probe in millimeter scale
4
Description
Mandibular Protrusive Movement
Timepoint
Measurement of the Mandibular Protrusive Movement before the Study; 30 Days after the Completion of the Laser Treatment Period; 30 and 90 Days after Using Digital Occlusal Splint.
Method of measurement
Using a Periodontal Probe in millimeter Scale
Intervention groups
1
Description
Intervention Group 1: 300mW Diode Laser Irradiation for 10 Seconds Bilaterally in the Upper, Middle and Lower Points of the Masseter Muscle; the Anterior Temporal Muscle and the Sternocleidomastoid Muscle
Category
Treatment - Devices
2
Description
Intervention Group 2: 300mW Diode Laser Irradiation for 10 Seconds Bilaterally in the Upper, Middle and Lower Points of the Masseter Muscle; the Anterior Temporal Muscle; the Sternocleidomastoid Muscle and the Superior, Inferior, Anterior and Posterior Points of the TMJ.
Category
Treatment - Devices
3
Description
Control group: In the Similar Conditions to the Laser Treatment Group, only Red Light and Laser Warning Sound will be used
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Dental Prostheses, Shahid Beheshti Faculty of Dentistry
Full name of responsible person
Leili Habibi
Street address
Shahid Beheshti Faculty of Dentistry; Shahid Beheshti University of Medical Sciences; Daneshjoo Blvd; Evin Blvd.
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2217 5351
Email
Hiyam1365@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Shahid Beheshti Dental School; Shahid Beheshti University of Medical Sciences; Evin Blvd.
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2990 2302
Email
hiyam1365@yahoo.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
Sara Tavakolizade
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shahid Beheshti Dental School; Shahid Beheshti University of Medical Sciences; Evin Blvd.
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2990 2302
Email
saratavakolizadeh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sara Tavakolizade
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shahid Beheshti Dental School; Shahid Beheshti University of Medical Sciences; Evin Blvd.
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2990 2302
Email
saratavakolizadeh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Leili Habibi
Position
Postgraduate student of prosthodontics
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Velenjak
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2217 5351
Fax
Email
Habibileila1366@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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All Patient's Data Including Age, Sex and results
Research will be Shareable After Making Individuals Undistinguishable.
When the data will become available and for how long
At the Same Time as Publishing Results
To whom data/document is available
Researchers in Academic and Scientific Institutions