Studying the effect of low-level laser therapy on pain and mouth opening in patients with temporomandibular joint disorders
Design
A controlled, parallel-group, double-blind, randomized, phase 3 clinical trial on 30 patients. Sealed opaque envelopes will be used for randomization.
Settings and conduct
The study will be conducted in the Department of Oral Medicine, Tabriz Faculty of Dentistry. The patient will be positioned semi-supine and irradiated with a laser for 40 seconds at 12 extra-oral points (5 points in the joint area and 7 in the muscles). The participant and the outcome assessor will be blinded to the group assignment.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Patients with temporomandibular joint disorders diagnosed by an oral medicine specialist.
2. Willingness to participate and providing informed consent.
3. Age range between 15-40 years.
4. Maximum vertical mouth opening less than 4 cm.
5. Presence of pain or clicking
Exclusion criteria:
1. Presence of systemic diseases with a history of cancer, radiotherapy, or chemotherapy.
2. Presence of a mass in the jaw, face, or neck area.
3. Presence of active infection in the jaw region.
4. Inferior alveolar nerve injury.
5. Depression.
6. Heart disease or cardiac pacemaker.
7. Rheumatoid arthritis.
8. Pregnancy.
9. Psychiatric disorders or seizures.
10. Use of anticholinergic drugs.
11. Unwillingness to participate or lack of patient cooperation.
12. Use of NSAIDs or analgesics during the last two weeks.
Intervention groups
Intervention group: They will receive supportive treatments and low-level diode laser.
Control group: They will receive supportive treatments (warm compresses, muscle relaxant methocarbamol 500 mg every 8 hours, Ibuprofen 400 mg every 12 hours, habit modification and stretching exercises) and inactive laser.
Main outcome variables
Pain level, mouth opening level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20251004067495N1
Registration date:2025-12-05, 1404/09/14
Registration timing:prospective
Last update:2025-12-05, 1404/09/14
Update count:0
Registration date
2025-12-05, 1404/09/14
Registrant information
Name
Rekar Salam Ali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3336 3298
Email address
rekarr1311@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-12-11, 1404/09/20
Expected recruitment end date
2026-01-10, 1404/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of low level laser therapy on pain and mouth opening in patients with temporomandibular joint disorders
Public title
Evaluation of the effect of low level laser therapy on temporomandibular joint disorders
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Temporomandibular disorders diagnosed by an oral medicine specialist
Having informed consent to participate in the study
Age range: 15–40 years
Vertical mouth opening less than 4 centimeters
Presence of pain or clicking in Temporomandibular joint
Exclusion criteria:
Presence of systemic diseases with a history of cancer, radiotherapy, or chemotherapy
Presence of a mass in the jaw, facial, or neck region
Presence of an active infection in the jaw region
Injury to the inferior alveolar nerve
Cardiac disease, cardiac pacemaker
Rheumatoid arthritis
Pregnancy
Mental health problems, seizure
Depression
Using anticholinergic drugs
Patients unwillingness to participate and lack of cooperation
Use of NSAIDs and analgesics in past 2 weeks
Age
From 15 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals will be randomly assigned to two groups using sealed opaque envelopes. First, 15 cards will be labeled "A" and 15 cards will be labeled "B." Then, a random assignment list will be generated using a random number table. In this way, for the numbers in the table, they will be extracted as two digits. If the number is less than 50, "A" will be assigned, and if it is more than 50, "B" will be assigned. The cards will be placed in opaque envelopes in random order and sealed. The envelopes will be placed in a box. At the start of participant registration, each participant will randomly select an envelope from the box and give it to the researcher in charge of randomization. The person in charge will open the envelopes and record the group assigned to each individual.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study will be double-blind, and the patient and the person assessing the outcomes will not be aware of the groupings, and only the person applying the laser and the person responsible for randomization will be aware of the grouping. Also, the laser device will be turned on in the control group to make its sound, but the laser will not be activated, and since all patients' eyes will be closed to protect them from the laser light, they will not notice whether the laser is active or not.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz university of medical sciences fuculty of dentistry
Street address
Golgasht
City
Tabriz
Province
East Azarbaijan
Postal code
5166614776
Approval date
2025-08-10, 1404/05/19
Ethics committee reference number
IR.TBZMED.REC.1404.376
Health conditions studied
1
Description of health condition studied
Temporomandibular joint disorders
ICD-10 code
M26.6
ICD-10 code description
Temporomandibular joint disorders
Primary outcomes
1
Description
The pain level
Timepoint
At the (first, fifth, and tenth) sessions.
Method of measurement
It will be assessed using the visual analogue scale, where the most severe and unbearable pain is rated as 10, and complete absence of pain is rated as 0. The measurement will be performed at all three stages while the patient is at rest.
2
Description
Mouth opening level
Timepoint
At the (first, fifth, and tenth) sessions.
Method of measurement
Maximum mouth opening will be measured using a ruler. The distance between the incisal edges of the upper and lower centrals will be measured at maximum opening. The measurement of maximum mouth opening will be repeated three times and the average of the results will be recorded.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Supportive treatments for temporomandibular joint disorders including warm compresses, muscle relaxants Methocarbamol 500 mg every 8 hours, Ibuprofen 400 mg every 12 hours, habit modification and stretching exercises, along with laser therapy with a low-level diode laser with a wavelength of 980 nm.
Category
Rehabilitation
2
Description
Control group: Supportive treatments for temporomandibular joint disorders including warm compresses, muscle relaxants Methocarbamol 500 mg every 8 hours, Ibuprofen 400 mg every 12 hours, habit modification and stretching exercises, along with inactive laser.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz university of medical sciences
Full name of responsible person
Hosein eslami
Street address
Golgasht
City
Tabriz
Province
East Azarbaijan
Postal code
5166614776
Phone
+98 41 3336 3298
Email
rekarr1311@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hosein eslami
Street address
Golgasht
City
Tabriz
Province
East Azarbaijan
Postal code
5166614776
Phone
+98 41 3336 3298
Email
eslamihosein56@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Hosein eslami
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Golgasht
City
Tabriz
Province
East Azarbaijan
Postal code
5166614776
Phone
+98 41 3336 3298
Email
eslamihosein56@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hosein eslami
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Golgasht
City
Tabriz
Province
East Azarbaijan
Postal code
5166614776
Phone
+98 41 3336 3298
Email
eslamihosein56@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Rekar Salam Ali
Position
Dental student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Golgasht
City
Tabriz
Province
East Azarbaijan
Postal code
5166614776
Phone
+98 41 3336 3298
Email
rekarr1311@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
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
18 months after the publication of the article resulting from the thesis
When the data will become available and for how long
18 months after the publication of the article resulting from the thesis
To whom data/document is available
Public
Under which criteria data/document could be used
For therapeutic and research purposes
From where data/document is obtainable
Through email with the project supervisor
What processes are involved for a request to access data/document