Comparison of thermotherapy and low power laser treatment in patients with (TMD)Temporo mandibular joint disorder
Design
Clinical trial with parallel intervention groups is randomized, without blinding and random sampling method. The randomization method is simple and uses the random numbers chart. 33 people were divided into three groups. Laser, diathermy treatment and hot pack will be used for the first, second and third groups, respectively, with the same drug. Finally, the amount of pain and the amount of mouth opening in the groups will be measured and compared.
Settings and conduct
The study will be performed in the maxillofacial surgery department of Tabriz Dental School. Three different groups of patients with Temporo mandibular joint disorder will be treated with three different treatments including low power laser, diathermy and hot pack for 12 sessions (two sessions per week). The severity of the pain and the amount of mouth opening will be measured.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. People with myofascial orofacial pain 2. Restricted mouth opening 3. Aratralgic 4. Difficulty chewing 5. Patients with pain in the masticatory and joint muscles, whether during compression or during jaw movements due to a disorder of the temporomandibular joint. Withdrawal conditions: 1. Abnormal skeletal occlusions (class II and class III occlusion) 2. Systemic disorders affecting the temporomandibular joint 3. Patients who have received analgesic or anti-stress drugs during the previous two weeks 4. Suspected pulpitis teeth 5. Children 6. Pregnant and lactating women 7. Patients with epilepsy
Intervention groups
Intervention group 1: Laser treatment
Intervention group 2: Diathermy treatment
Intervention group 3: Hot pack treatment
Main outcome variables
The amount of pain
The amount of mouth opening
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201124049483N1
Registration date:2020-11-27, 1399/09/07
Registration timing:registered_while_recruiting
Last update:2020-11-27, 1399/09/07
Update count:0
Registration date
2020-11-27, 1399/09/07
Registrant information
Name
Reza Khorshidi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3335 7314
Email address
dr_khorshidi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-20, 1399/08/30
Expected recruitment end date
2020-12-20, 1399/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of thermotherapy and low power laser treatment in patients with (TMD)Temporo mandibular joint disorder
Public title
Comparison of two different treatments in patients with jaw disorders
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People with myogenic orofascial pain
Restrict mouth opening
Aratralgic
Difficulty chewing
Patients with pain in the masticatory and joint muscles
Exclusion criteria:
Abnormal skeletal occlusions (class II and class III occlusion)
Systemic disorders that affect the temporomandibular joint
Patients who have received analgesic or anti-stress medications in the past two weeks
Teeth suspected of pulpitis
Children
Pregnant and lactating women
Patients with epilepsy
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
33
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling method is random among the people referring to the maxillofacial surgery department of Tabriz Dental School. The randomization method is simple and the unit is individual. Our tool for randomization is the randomized number chart. Furthermore, the allocation of treatment to patients will be done Randomly. To do this, the types of treatment are identified with code A (diathermy) , B (laser) and C(hot pack ), and then will be placed in sealed envelopes and will be stirred. Then they are randomly taken out of the bag and after observing the code, the treatment will be given to the patient. None of the patients will be informed about another patient's treatment.
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 Tabriz University of Medical Sciences
Street address
Floor2, Central Building No.2, Tabriz University of Medical Sciences, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Approval date
2020-11-24, 1399/09/04
Ethics committee reference number
IR.TBZMED.REC.1399.799
Health conditions studied
1
Description of health condition studied
Temporomandibular joint disorder
ICD-10 code
M26.6
ICD-10 code description
Temporomandibular joint disorders
Primary outcomes
1
Description
The amount of pain
Timepoint
Before and after the study
Method of measurement
Visual Analogue Scale
2
Description
The amount of mouth opening
Timepoint
Before and after the study
Method of measurement
10 cm ruler calibrated in millimeters
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Laser group: Laser treatment will be performed through a low-power laser device available in Imam Reza Hospital in Tabriz. The patient will be treated for 12 sessions. In this study, a low-power gallium aluminum arsenide GaAlAs METRON laser made in Australia was used using a pen applicator with a cross-sectional area of one centimeter of radiation. The device was calibrated by the engineering company before conducting the research. The specifications of the laser used in this research were as follows: Wavelength = 810 nm Energy density = J / cm2 5 power = mw 100 time = 50 seconds are treated with laser anywhere. We place the probes of the device based on the trigger points and pain places in the desired location. We will place the Red probe on the joint and the INFRARED Scanner on the trigger points in the masticatory muscles.
Category
Treatment - Devices
2
Description
Intervention group: Diathermy group: We place the electrodes of the device in the points of pain and joint. To prevent skin burns between the electrode and the body, we use special oils. The current between the electrodes warms the tissue in the body and induces its therapeutic effects in this way. The patient will be treated for 12 sessions.
Category
Treatment - Devices
3
Description
Intervention group: Hot Pack Group: By bending the piece inside the hot pack, the liquid inside the bag slowly becomes solid and generates high heat for about 15 minutes. To reuse the hot pack bag, it should be placed in hot water for about 5 to 10 minutes so that the material inside the bag becomes liquid again, and you can use the bag again whenever you want. The bag is placed on the spot for ten minutes.The patient will be treated for 12 sessions.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Oral and Maxillofacial Surgery, School of Dentistry, University of Tabriz
Full name of responsible person
Reza Khorshidi
Street address
Floor2, Central Building No.2, Tabriz University of Medical Sciences, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7314
Email
dr_khorshidi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Prof. Mohammad Samiei
Street address
Floor2, Central Building No.2, Tabriz University of Medical Sciences, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7314
Email
dr_khorshidi@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
Reza Khorshidi
Position
Lecturer
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Floor2, Central Building No.2, Tabriz University of Medical Sciences, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7314
Email
dr_khorshidi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Reza Khorshidi
Position
lecturer
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Floor2, Central Building No.2, Tabriz University of Medical Sciences, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7314
Email
dr_khorshidi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Reza Khorshidi
Position
lecturer
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Floor2, Central Building No.2, Tabriz University of Medical Sciences, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7314
Email
dr_khorshidi@yahoo.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