IRCT | Investigating the quality of life and pain and maximum mouth opening in patients with temporomandibular disorders referring to the jaw and face pain clinic of Semnan Faculty of Dentistry with the complementary treatment of laser acupuncture.

Protocol summary

Study aim: Investigating the effect of complementary treatment of temporomandibular disorders with laser acupuncture on improving quality of life
Design: A clinical trial with a control group, with parallel groups, double-blind, randomized, on 20 patients. Block was used for randomization.
Settings and conduct: Study done in the physiotherapy clinic of Semnan and using low power diode laser machine. The study is double-blind and the patients do not know which group they are in. A dental student, who is not aware of the groupings, measures the variables before and after the study and Executive officer of study inform the physiotherapist about the groupings for treatment, which is laser treatment for the treatment group or only the guiding light of the device for the control group.
Participants/Inclusion and exclusion criteria: inclusion criteria: 1- Patients with a history of pain 2- Restriction in jaw movements 3_ Jaw sound 4- Deviation during opening and closing the mouth exclusion criteria: 1- Patients with a history of acute trauma 2- Patients who have been treated for temporomandibular joint disorders in the last month. 3- Any pain of other origin
Intervention groups: For the target group of 10 patients, laser therapy with LUMIX 2 HFPL low power diode laser device made in Italy with wavelength nm810, output power mw500 and energy density j/cm2 21, frequency 13 kHz, output energy J 16.4 and modulation 100% with continuous waveform to Duration of 3 minutes in each acupuncture point, which is 30 minutes for a total of 10 points. The treated points include: GB20, SI19, ST6, ST7, LI4, which will be treated bilaterally. 2- For the placebo group of 10 patients, only the guiding light of the device will be used as laser acupuncture in the same areas and frequency and time as the first group .
Main outcome variables: Increasing the quality of life, reducing pain, increasing the maximum opening of the mouth

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20230812059121N1

Registration date: 2023-09-18, 1402/06/27

Registration timing: registered_while_recruiting

Last update: 2023-09-18, 1402/06/27

Update count: 0
Registration date: 2023-09-18, 1402/06/27

Registrant information: Name

Mohaddeseh Davari

Name of organization / entity

Country

Iran (Islamic Republic of)

Phone

+98 23 3333 5363

Email address

mdavari@semums.ac.ir

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2023-08-14, 1402/05/23
Expected recruitment end date: 2024-08-13, 1403/05/23
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: Investigating the quality of life and pain and maximum mouth opening in patients with temporomandibular disorders referring to the jaw and face pain clinic of Semnan Faculty of Dentistry with the complementary treatment of laser acupuncture.

Public title: Investigating the effect of laser acupuncture on the quality of life of patients with temporomandibular disorders
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

Patients with a history of pain with VAS≥4 in masticatory muscles and/or temporomandibular joint during jaw movements or function (TMD muscle disorders (Class Ia, Ib) or anterior displacement of the disc with or without return (Class IIa, IIb) or arthralgia ( Class IIIa) based on (RDC/TMD) Limitations in jaw movements (mouth opening < 40 mm or side movements < 8 mm) Jaw sound while opening and closing the mouth Deviation during opening and closing the mouth

Exclusion criteria:

Patients with a history of acute trauma Patients who have been treated for temporomandibular joint disorders in the last month Any pain with other origins such as decayed teeth, impacted teeth, other pathological lesions or neurological disorders in the head and neck area People with congenital and neoplastic diseases in the TMJ range People with joint diseases such as osteoarthritis and rheumatoid arthritis or suffering from hypermobility syndrome Uncontrolled systemic problems with disability (ASA II or higher) including diabetes, thyroid disease, kidney disease, epilepsy and people with cerebrovascular problems People with bleeding diseases or users of anticoagulants Users of corticosteroid drugs Cardiac patients or those with a pacemaker Pregnant or breastfeeding mothers Patients with psychiatric disorders such as severe depression and psychosis Patients with any severe orthognathic deformities Patients with posterior edentulousness
Age: No age limit
Gender: Both

Phase

N/A

Groups that have been masked

Participant
Outcome assessor

Sample size

Target sample size: 20

Randomization (investigator's opinion)

Randomized

Randomization description

In the first stage, patients are included in the study by meeting the criteria for entering the study. Therefore, our sampling method is easy at this stage. In the second stage, they are divided into two groups A and B using the block randomization method. Then, in the third step, using the table of random numbers, we determine which group will receive treatment and which group will receive placebo.

Blinding (investigator's opinion)

Double blinded

Blinding description

The patients are informed that this plan is a study and includes two treatment and control groups, but they do not know about their group, and a dental student measures the variables of the study before and after the treatment, who is blind to the groupings. The executive officer of the plan informs the physiotherapist about the groups to use the laser for the treatment group and the guiding light of the device for the control group.

Placebo

Used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Semnan University of Medical Sciences

Street address

dental clinic،hefdah shahrivar Blvd

City

semnan

Province

Semnan

Postal code

35187-94431
Approval date: 2023-08-17, 1402/05/26
Ethics committee reference number: IR.SEMUMS.REC.1402.091

Health conditions studied

1

Description of health condition studied: temporomandibular disorders
ICD-10 code: M26.60
ICD-10 code description: Temporomandibular joint disorder, unspecified

Primary outcomes

1

Description: quality of life
Timepoint: The beginning and end of the study and One month after the last treatment session
Method of measurement: questionnaire

2

Description: Maximum mouth opening
Timepoint: The beginning and end of the study and One month after the last treatment session
Method of measurement: Ruler with millimeter division

3

Description: pain
Timepoint: The beginning and end of the study and One month after the last treatment session
Method of measurement: Visual Analogue Scale

Secondary outcomes

empty

Intervention groups

1

Description: Intervention group: Laser therapy with LUMIX 2 HFPL low power diode laser machine made in Italy with wavelength nm810, output power mw500 and energy density j/cm2 21, frequency 13 kHz, output energy J 16.4 and modulation 100% with continuous waveform for 3 minutes. It takes 30 minutes for each acupuncture point, for a total of 10 points. The points under treatment include: GB20, SI19, ST6, ST7, LI4, which will be treated bilaterally. Both groups visit twice a week for a total of 10 sessions.
Category: Treatment - Devices

2

Description: Control group: Only the guiding light of the device will be used as laser acupuncture in the same areas and with the same frequency and time as the first group.
Category: Treatment - Devices

Recruitment centers

1

Recruitment center: Name of recruitment center

Semnan Faculty of Dentistry

Full name of responsible person

Maryam Shirnasab

Street address

hefdah shahrivar

City

semnan

Province

Semnan

Postal code

35187-94431

Phone

+98 991 768 2789

Email

shirin1998f@gmail.com

1

Sponsor: Name of organization / entity

Semnan University of Medical Sciences

Full name of responsible person

Rasool Bagheri

Street address

hefdah shahrivar

City

semnan

Province

Semnan

Postal code

35187-94431

Phone

+98 991 768 2789

Email

Rasool.bagheri@ymail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: No
Title of funding source: Faculty of Physiotherapy
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

Semnan University of Medical Sciences

Full name of responsible person

Rasool Bagheri

Position

Assistant Professor

Latest degree

Specialist

Other areas of specialty/work

Physiotherapy

Street address

hefdah shahrivar

City

semnan

Province

Semnan

Postal code

35187-94431

Phone

+98 910 073 7438

Email

Rasool.bagheri@ymail.com

Person responsible for scientific inquiries

Contact: Name of organization / entity

Semnan University of Medical Sciences

Full name of responsible person

Nahid Karbasi

Position

Assistant Professor

Latest degree

Specialist

Other areas of specialty/work

Dentistry

Street address

Hefdeh Shahrivar Street

City

semnan

Province

Semnan

Postal code

3518794431

Phone

+98 913 397 8074

Email

sov.karbasi@gmail.com

Person responsible for updating data

Contact: Name of organization / entity

Semnan University of Medical Sciences

Full name of responsible person

Maryam Shirnasab

Position

student

Latest degree

A Level or less

Other areas of specialty/work

Dentistry

Street address

Hefdeh Shahrivar Street

City

semnan

Province

Semnan

Postal code

35187-94431

Phone

+98 991 768 2789

Email

shirin1998f@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: Information on the main outcome is shared
When the data will become available and for how long: شروع دوره دسترسی 4ماه پس از چاپ نتایج
To whom data/document is available: محققین شاغل در موسسات دانشگاهی و علمی
Under which criteria data/document could be used: It can be used by mentioning the source
From where data/document is obtainable: Maryam Shiransab with email address:shirin1998f@gmail.com
What processes are involved for a request to access data/document: Accept the request until 2 months later
Comments

Investigating the quality of life and pain and maximum mouth opening in patients with temporomandibular disorders referring to the jaw and face pain clinic of Semnan Faculty of Dentistry with the complementary treatment of laser acupuncture.