Protocol summary

Study aim
Effect of 940 nm LLLT on TMD treatment
Design
Clinical trial with control group, parallel groups, three blinded, randomized, phase 2 on 34 patients. The Rand function of Excel 2010 software was used for randomization.
Settings and conduct
In this three-blind randomized clinical trial, 34 patients with symptoms of TMD will be randomly divided into intervention and placebo groups (n = 17). In the intervention group, 940 nm laser by Epic X biolase laser device (CA, USA) in a specialized light and laser clinic, with an output power of 300 mW with energy density of 2.5 J / cm2, in direct contact technique to the TMJ area for 20 seconds , Twice a week for 4 weeks.The groups will be evaluated in terms of pain intensity, rate of mouth opening, deviation during mouth opening and clicking sound.
Participants/Inclusion and exclusion criteria
Intrusion criteria: limited mouth opening or function presence of pain in masticatory muscles and/or TMJs, either in clenching or in jaw movements (TMD muscular disturbance or arthralgia. Exclusion criteria: patients who had major systemic disorders patients who received analgesic or anti-depressant over the last 2 weeks patients who had any bony abnormalities of the jaws such as arthropathy of the TMJ or rheumatoid arthritis Patients with psychological illness patients who received any form of treatment for TMD within the last month pregnant and feeding patients.
Intervention groups
Intervention group: This group will be exposed to 940 nm laser with a power of 300 mW and to the temporomandibular joint area for 20 seconds two sessions per week for four weeks. In the same way, the placebo group will be exposed to Palsbo laser (device with laser off).
Main outcome variables
Patient satisfaction,Intensity of pain,The amount of mouth opening,Clicking sound,Deviation when opening the mouth

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180224038840N3
Registration date: 2022-04-23, 1401/02/03
Registration timing: registered_while_recruiting

Last update: 2022-04-23, 1401/02/03
Update count: 0
Registration date
2022-04-23, 1401/02/03
Registrant information
Name
Seyyed Amir Seyyedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3322 4288
Email address
seyedi.a@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-21, 1401/01/01
Expected recruitment end date
2022-06-22, 1401/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of 940 nm Low-level Laser Therapy on Treatment of Patients with Tempromandibular Joint Disorders
Public title
Effect of laser Therapy in Tempromandibular Joint Disorders
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
limited mouth opening or function presence of pain in masticatory muscles and/or TMJs, either in clenching or in jaw movements (TMD muscular disturbance (class Ia, Ib) or arthralgia (class IIIa).
Exclusion criteria:
patients who had major systemic disorders patients who received analgesic or anti-depressant over the last 2 weeks patients who had any bony abnormalities of the jaws such as arthropathy of the TMJ or rheumatoid arthritis Patients with psychological illness patients who received any form of treatment for TMD within the last month pregnant and feeding patients
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
  • Data and Safety Monitoring Board
Sample size
Target sample size: 34
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly divided into two groups A and B, using Microsoft Excel software. In this way, for each new patient, an integer is randomly assigned from 1 to 34, and then in the software, each of these numbers will be randomly entered into one of the groups A or B.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Patients، Researcher and Statist are blinded of sample assignment.Patients in both groups will not be aware of the effect of the laser. The Principal Investigator and statist do not know the nature of groups A and B. The examiner in charge of patient care is not aware of the type of patient grouping.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Urmia University of Medical Sciences
Street address
Third floor, Jam Doctors Building, Madani Street 2,
City
Urmia
Province
West Azarbaijan
Postal code
5713815555
Approval date
2021-11-01, 1400/08/10
Ethics committee reference number
IR.UMSU.REC.1400.285

Health conditions studied

1

Description of health condition studied
Tempromandibular Joint disorders
ICD-10 code
M26.6
ICD-10 code description
Temporomandibular joint disorders

Primary outcomes

1

Description
The number of pain intensity on visual analogue scale (VAS)
Timepoint
Measurement of pain intensity before the intervention, 2 weeks and 4 weeks after the start of the intervention and 1 month after the end of the treatment sessions.
Method of measurement
visual analogue scale (VAS)

Secondary outcomes

1

Description
amount of mouth opening
Timepoint
Measurement of pain intensity before the intervention, 2 weeks and 4 weeks after the start of the intervention and 1 month after the end of the treatment sessions
Method of measurement
Digital ruler

2

Description
The amount of deviation while opening the mouth
Timepoint
Measurement of pain intensity before the intervention, 2 weeks and 4 weeks after the start of the intervention and 1 month after the end of the treatment sessions
Method of measurement
Observation

3

Description
Satisfaction with treatment
Timepoint
In the last session of laser treatment
Method of measurement
questionnaire

4

Description
Click sound
Timepoint
Measurement of pain intensity before the intervention, 2 weeks and 4 weeks after the start of the intervention and 1 month after the end of the treatment sessions
Method of measurement
Hearing

Intervention groups

1

Description
Intervention group: In the intervention group, 940 nm laser by Epic X biolase laser device (Ezlase; Biolase Technology, Inc., Irvine, CA, USA) will be used after review and calibration by the manufacturer, in the light and laser clinic, with output power of 300 mW in continuous mode, under dedicated control, With an energy density of 2.5 J / cm2 at detected sensitive points for 20 seconds, 2 times per week, totalling 4 weeks, in direct contact technique to the painful points.
Category
Treatment - Other

2

Description
Control group: Control group, In the same way the laser group, will be irradiated with a placebo laser (device with laser off). Patients will not be aware of the type of radiation (device on or off).
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Alborz Clinic
Full name of responsible person
Seyyedi Seyyed Amir
Street address
Alborz Street, Alborz, U0rmia
City
Urmia
Province
West Azarbaijan
Postal code
۵۷۱۹۷۳۶۱۹۱
Phone
+98 44 3336 3600
Email
seyyediamir@yahoo.com
Web page address
https://umsu.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
professor Iraj Mohebbi
Street address
Alborz Dental Cilinic,Alborz Ave,Urmia Town
City
Urmia
Province
West Azarbaijan
Postal code
571478734
Phone
+98 44 3223 4897
Email
seyyediamir@yahoo.com
Web page address
https://umsu.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Seyyed Amir Seyyedi
Position
Faculty
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Emergency Alley, Resalat Boulevard
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Fax
Email
seyyediamir@yahoo.com
Web page address
https://umsu.ac.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Seyyed Amir Seyyedi
Position
faculty
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Emergency Alley, Resalat Boulevard
City
Urmia
Province
West Azarbaijan
Postal code
5719736191
Phone
+98 44 3224 0860
Fax
Email
seyyediamir@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Zahra hajizadeh
Position
General Medicine Student
Latest degree
Master
Other areas of specialty/work
Dentistry
Street address
Alborz Dental Clinic, Alborz street, Urmia city
City
Urmia
Province
West Azarbaijan
Postal code
۵۷۱۹۷۳۶۱۹۱
Phone
+98 44 3336 3600
Email
zahrahajizadeee19@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
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
Title and more details about the data/document
34 patients referred to the diagnostic department of Alborz Dental Clinic who have signs and symptoms related to Tempromandibular Joint Disorders will be used in the study.
When the data will become available and for how long
4 month
To whom data/document is available
Researchesr
Under which criteria data/document could be used
Confidential
From where data/document is obtainable
Researchers
What processes are involved for a request to access data/document
Permission from the Ethics Committee
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