Protocol summary

Study aim
To compare the effect (short-term and long-term) of three treatment methods using splint, low level laser and combination of low level laser and splint on complications of TMD.
Design
This study is a randomized clinical trial.
Settings and conduct
30 patients with orofacial pain who are referred to the Department of the prosthesis at Dental School of Shahid Beheshti University of Medical Sciences, Tehran, are recruited according to the mentioned inclusion and exclusion criteria. All patients are examined and diagnosed with a temporomandibular joint disorder according to RDC / TMD criteria are included in the study. The patient is asked to sign the informed consent form. Patients are randomly allocated to three groups of stabilization splint, low power laser therapy, and combination therapy (low power laser + stabilization splint).
Participants/Inclusion and exclusion criteria
Major inclusion criteria: Age 18-60, Chronic orofacial pain (more than three months) with or without restriction in opening the mouth, Diagnosis of Temporomandibular disorder (pain-related or intra-articular disorders) based on the RDC / TMD diagnostic criteria. Major exclusion criteria: Recent fracture of mandibular bone, History of recent facial trauma, Congenital/developmental disorders of the jaw, History of previous treatment for TMD during the last month, Systemic musculoskeletal disease, Fibromyalgia., Previous or current history of cancer, Skin lesions at the laser site, Pregnancy.
Intervention groups
Three groups: Stabilization splint treatment, low-level laser treatment, and combination treatment (low-level laser + Stabilization splint).
Main outcome variables
Outcomes include the severity of pain, the extent of maximal opening of the patient's mouth, the extent of the patient's maximum ability to perform lateral and anterior mandibular movements, and the extent of limitation of jaw functions.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20211010052719N1
Registration date: 2021-10-26, 1400/08/04
Registration timing: registered_while_recruiting

Last update: 2021-10-26, 1400/08/04
Update count: 0
Registration date
2021-10-26, 1400/08/04
Registrant information
Name
Mahdi Shamali
Name of organization / entity
University of Southern Denmark
Country
Denmark
Phone
+45 65 50 10 00
Email address
mshamali@health.sdu.dk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-10, 1399/06/20
Expected recruitment end date
2021-12-30, 1400/10/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effects of three conservative treatment methods on temporomandibular disorders
Public title
Investigation of the effects of three conservative treatment methods on temporomandibular disorders
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Chronic orofacial pain (more than three months) with or without restriction in opening the mouth. Diagnosis of Temporomandibular disorder (Axis I) based on the RDC / TMD diagnostic criteria. History of no previous treatment for TMD during the last month. Having natural dentition
Exclusion criteria:
Recent fracture of mandibular bone. History of recent facial trauma Congenital / developmental disorders of the jaw. Systemic musculoskeletal disease. Fibromyalgia. Previous or current history of the cancer. Skin lesions at the laser site. Pregnancy. Diagnosis of Temporomandibular disorder of articular origin based on the RDC / TMD diagnostic criteria.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomly allocated to 3 treatment groups. A central randomization unit was contacted by phone to ensure allocation concealment and assign the enrolled patient to each treatment group. The central randomization unit had prepared a list of numbers from 1 to 30 that were allocated randomly to 3 equal groups using a website (https://www.random.org.) which generated a list of random numbers in 3 columns. Before randomization, the first column was considered the Stabilization splint treatment group, the second column the low level laser treatment group, and the third column the combination treatment group (low level laser + Stabilization splint).
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
the Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Daneshjoo Blvd, Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
19839-63113
Approval date
2020-09-09, 1399/06/19
Ethics committee reference number
IR.SBMU.DRC.REC.1399.042

Health conditions studied

1

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

Primary outcomes

1

Description
Pain intensity
Timepoint
Before treatment, immediately after treatment, one month and three months after the end of treatment
Method of measurement
visual scale analogue (VAS)

2

Description
Maximum mouth opening with NO assistance
Timepoint
Before treatment, immediately after treatment, one month and three months after the end of treatment
Method of measurement
By ruler in millimeters

3

Description
Right & left and anterior lateral movement of mandible
Timepoint
Before treatment, immediately after treatment, one month and three months after the end of treatment
Method of measurement
By ruler in millimeters

4

Description
Functional limitations of jaw
Timepoint
Before treatment, immediately after treatment, one month and three months after the end of treatment
Method of measurement
visual scale analogue (VAS)

Secondary outcomes

empty

Intervention groups

1

Description
Stabilization splint treatment group: Splints are made according to Okeson's instructions and necessary adjustments are made. The patient is instructed to use the splint for 12 hours a day for three months. The outcomes are evaluated at intervals before splint treatment, one month, three months, after the start of treatment.
Category
Treatment - Devices

2

Description
Low level Laser treatment group: A diode laser device, noncontact mode, continuous wave, 0.1 W (100 mW), 810 nm, 6 J / cm, 2,60 s / session are used, which is performed in three sessions per week for three weeks ( A total of nine sessions). The laser is applied to the origin, insertion, and body areas of the masseter muscle and the anterior, middle, and posterior parts of the temporalis muscle , as well as to the center of the upper joint space, about one cm in front of the tragus. The outcomes are evaluated at intervals before splint treatment, one month, three months, after the start of treatment.
Category
Treatment - Devices

3

Description
Combination treatment group: This group of treatments is initially treated with low level laser according to the mentioned protocol. Then, immediately after the end of the laser treatment, they are treated with a splint according to the protocol for three months. The outcomes are evaluated at intervals before splint treatment, one month, three months, after the start of treatment.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zahra Afshari
Street address
Daneshjoo Blvd, Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
19839-63113
Phone
+98 21 2243 9770
Email
afsharyzhra1@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Daneshjoo Blvd, Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
19839-63113
Phone
+98 21 2243 9780
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
70
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zahra Afshari
Position
Resident of Prosthodontics
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Daneshjoo Blvd, Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
19839-63113
Phone
+98 31 5366 4431
Email
afsharyzhr1@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zahra Afshari
Position
Resident of Prosthodontics
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Daneshjoo Blvd, Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
19839-63113
Phone
+98 31 5366 4431
Email
afsharyzhr1@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
University of Southern Denmark
Full name of responsible person
Mahdi Shamali
Position
Post doc
Latest degree
Ph.D.
Other areas of specialty/work
Health sceinces
Street address
Campusvej 55
City
Odense
Province
Fyn
Postal code
5230 Odense
Phone
+45 65 50 10 00
Email
gezaltoshmal@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
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