The effectiveness of intra-articular Triamcinolone injection compared to 940nm diod laser therapy in the treatment of temporomandibular joint disorder (TMD) signs.
Comparison the efficacy of intra-articular triamcinolone injection and laser treatment onImproving the Symptoms of Temporomandibular Joint Disorders(TMD)
Design
Patients are randomly divided into two 33-member group. Random allocation will be done through block randomization method.
Settings and conduct
Patient with TMD referring to facial and maxillofacial surgery centers in Hamedan
Participants/Inclusion and exclusion criteria
Inclusion Criteria was Patients with symptoms of TMD including pain; joint sound; limitation of mouth opening and jawbone deviation during opening mouth through clinical examinations and Exclusion Criteria was Age younger than 20 or older than 40; History of any surgery or intervention in the TMJ joint; History of connective tissue or joints disease such as lupus; scleroderma; vasculitis and etc; History of long-term use of corticosteroids and anti-inflammatory drugs.
Intervention groups
Intervention group 1: Treatment included cleaning the skin of the injection area with alcoholic pad and injecting 1 ml of Lidocaine 2% to desensitize the area, asking the patient to open his mouth to the maximum possible size and injecting 0.5 ml of triamcinolone into posterior disk space. Needle gage 27was used for injection.
Intervention group: 940 nm diode laser was used to radiate point by point at the head of condyle from superior, inferior, anterior and posterior sides for 50 seconds. The intervention was run through 9 sessions (One day in between). Patients received high power laser (4 watts) in the first session. In the other sessions low power laser (0.5 watts) was used.
Main outcome variables
Pain, joint clicks
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180504039522N2
Registration date:2018-07-09, 1397/04/18
Registration timing:registered_while_recruiting
Last update:2018-07-09, 1397/04/18
Update count:0
Registration date
2018-07-09, 1397/04/18
Registrant information
Name
Ali Heidari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0320
Email address
ali.heidari68@umasha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of intra-articular Triamcinolone injection compared to 940nm diod laser therapy in the treatment of temporomandibular joint disorder (TMD) signs.
Public title
The Effect of Triamcinolone Injection and Diode Laser on Improving the Symptoms of Temporomandibular Joint Disorders
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with symptoms of TMD including pain, joint sound, limitation of mouth opening and jawbone deviation during mouth opening through clinical examinations
Exclusion criteria:
Age younger than 20 or older than 40
History of any surgery or intervention in the TMJ joint
History of connective tissue or joints disease such as lupus, scleroderma, vasculitis, etc.
History of long-term use of corticosteroids and anti-inflammatory drugs.
Age
From 20 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation will be done through block randomization method.
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 Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Blvd.
City
Hamadan
Province
Kohgilouyeh-va-Boyrahmad
Postal code
65156
Approval date
2018-01-13, 1396/10/23
Ethics committee reference number
IR.UMSHA.REC.1396.721
Health conditions studied
1
Description of health condition studied
temporomandibular joint disorder (TMD)
ICD-10 code
M26.60
ICD-10 code description
Temporomandibular joint disorder, unspecified
Primary outcomes
1
Description
Pain
Timepoint
Before treatment, one week later and one month later
Method of measurement
Visual Analog Scale(VAS)
2
Description
Joint klick
Timepoint
Before treatment, one week later and one month later
Method of measurement
Visual Analog Scale(VAS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Treatment included cleaning the skin of the injection area with alcoholic pad and injecting 1 ml of Lidocaine 2% to desensitize the area, asking the patient to open his mouth to the maximum possible size and injecting 0.5 ml of triamcinolone into posterior disk space. Needle gage 27was used for injection.
Category
Treatment - Drugs
2
Description
Intervention group 2: 940 nm diode laser was used to radiate point by point at the head of condyle from superior, inferior, anterior and posterior sides for 50 seconds. The intervention was run through 9 sessions (One day in between). Patients received high power laser (4 watts) in the first session. In the other sessions low power laser (0.5 watts) was used.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Oral and Maxillofacial Surgery medical centers in Hamedan
Full name of responsible person
Minoo Yavarikia
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh blvd
City
Hamadan
Province
Hamadan
Postal code
65156
Phone
+98 81 3838 0535
Fax
+98 81 3838 0535
Email
m.yavarikia@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Saeed Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh blvd
City
Hamadan
Province
Hamadan
Postal code
65156
Phone
+98 81 3838 0535
Email
saeedBashirian@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Dr Ali Heidari
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh blvd
City
Hamadan
Province
Hamadan
Postal code
65156
Phone
+98 81 3838 0535
Email
dr-heidari68@hotmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Ali Heidari
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh blvd
City
همدان
Province
Hamadan
Postal code
65156
Phone
+98 81 3838 0535
Email
dr-heidari68@hotmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Ali Heidari
Position
Assistant Profesor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh blvd
City
Hamadan
Province
Hamadan
Postal code
65156
Phone
+98 81 3838 0535
Email
dr-heidari68@hotmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not 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
No - There is not 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
Only part of the original outcome information or the like can be shared.
When the data will become available and for how long
From the April first, 2019
To whom data/document is available
Data will be available for researchers working in academic and scientific institutions or industry professionals.
Under which criteria data/document could be used
Only published results from the Thesis can be used
From where data/document is obtainable
Dr ali Heidari dr-heidari68@hotmail.com
What processes are involved for a request to access data/document
Send an email to dr-heidari68@hotmail.com and get up to 72 hours to receive the response