The aim of this study is to investigate the short term and long term therapeutic effects of low level laser therapy along with the use of conventional and digital occlusal spilint in treatment of tmd patient
Design
A concealed,randomized,unblinded,sham controlled clinical trial with two parallel group designed among 40 patient.the rand function of excel software was used for randomization
Settings and conduct
The place of study: department of dental prostheses,shahid beheshti dental school, Tehran
population: tmd patient
blinding: blinding was not done in this study
Participants/Inclusion and exclusion criteria
Inclusion criteria: age of patient between 20 and 50years, diagnosis of TMD based on DC/TMD and RDC/TMD criteria.
exclusion criteria: history of recent facial trauma, congenital or developmental disorder of the jaw, history or presence of systemic musculoskeletal disease, history or presence of cancer, pregnancy, history of previous treatment of TMD during the last month, using complete denture.
Intervention groups
1.Treatment with conventional occlusal splint
2.Treatment with conventional occlusal splint with low level laser therapy
3.Treatment with digital occlusal splint
4.Treatment with digital occlusal splint with low level laser therapy
Main outcome variables
Jaw motion limitation,discoloration,wear resistance and chaire time in occlusal splints
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220706055400N1
Registration date:2023-02-20, 1401/12/01
Registration timing:registered_while_recruiting
Last update:2023-02-20, 1401/12/01
Update count:0
Registration date
2023-02-20, 1401/12/01
Registrant information
Name
hossein akbari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 29901
Email address
hosseinakbari716@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-20, 1401/12/01
Expected recruitment end date
2023-06-22, 1402/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of conventional and digital occlusal splints with low power lasers in the treatment of patients with temporomandibular disorders
Public title
Effect of low level laser thrapy and occlusal spilint in treatment of TMD patient
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age Between 20 and 50 years, diagnosis of TMD base on DC/TMD and RCT/TMD ceriteria,click problems, limitation in maximum mouth opening and chronic orofacial pain more than 3 month.
Exclusion criteria:
History of recent facial trauma, congenital disorders, history of recent facial fracture, history or presence of recent musculoskeletal diseasesوhistory or presence of cancer
History or presence of skin problems, history or previous treatment
History or presence of psychological disorders,
Patient with odontogenic pain
Complete denture patient
Periodental disease
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The rand function of excel software was used for randomization, the allocation of patient to 4 treatment group is done in the form of randomization blocks.so that 5 blocks of 6 are defined, and in each of these blocks, the older of treatments is generated randomly with the excel program. Patients receive random treatment in these randomized blocks in the order of referral.
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 Shahid beheshti University of Medical Science
Street address
Daneshjoo blvd, evin, Shahid Chamran highway, tehran city
City
Tehran
Province
Tehran
Postal code
1983969411
Approval date
2022-05-24, 1401/03/03
Ethics committee reference number
IR.SBMU.DRC.REC.1401.041
Health conditions studied
1
Description of health condition studied
Temporomandibular disorder
ICD-10 code
M26.6
ICD-10 code description
Temporomandibular joint disorders
Primary outcomes
1
Description
Intensity of spontanous pain
Timepoint
Spontaneous pain measurement before the study, 30 days after the completion of the laser therapy period, 30 and 90 days after using the occlusal splint
Method of measurement
Visual analogue scale
Secondary outcomes
1
Description
Occlusal spilint discoloration
Timepoint
After 3 and 6 month
Method of measurement
After observation by clinician
2
Description
Time of occlusal spilint adjustment
Timepoint
Delivery appointment
Method of measurement
By watch chronometer
3
Description
Occlusal spilint wear resistance
Timepoint
After 3 and 6 month after delivery
Method of measurement
By gauge
4
Description
Patient satisfication
Timepoint
After 3 and 6 month of delivery
Method of measurement
By question of patient
5
Description
Maximum mouth opening
Timepoint
Measurement of the maximum opening before the study 30 day after completion the laser treatment period,30 and 90 day after using digital occlusal spilint
Method of measurement
Using a ruller in milimeter scale
Intervention groups
1
Description
Intervention group:Use diode laser with 300mA bilaterally in 10 seconds in superior,middle and inferior region of masseter and temporal,sternocleidomastoid and then use conventional occlusal splint for 6 month
Category
Treatment - Devices
2
Description
Intervention group:Intervention group:Use diode laser with 300mA bilaterally in 10 seconds in superior,middle and inferior region of masseter and temporal,sternocleidomastoid and then use Digital occlusal splint for 6 month
Category
Treatment - Devices
3
Description
Intervention group:use Digital occlusal splint for 6 month
Category
Treatment - Devices
4
Description
Intervention group: use conventional occlusal splint for 6 month
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of dental prostheses,Shahid Beheshti faculty of dentistry
Full name of responsible person
Hossein akari
Street address
Shahid Beheshti faculty of dentistry, Shahid Beheshti university of medicalsciences, Daneshjoo Blvd, Evin Blvd
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2217 5351
Email
Hosseinakbari716@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Vice president of research and Technology of Shahid Beheshti Univercity of Medical Sciences
Street address
Daneshjoo Blvd, Evin
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2217 5350
Fax
+98 21 2241 3896
Email
hosseinakari716@gmail.com
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
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Rahab ghoveyzi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Daneshjoo Blvd, Evin
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2217 5350
Fax
+98 21 2241 3896
Email
r.ghoveizi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Rahab Ghoveyzi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Daneshjoo Blvd
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2217 5350
Email
r.ghoveizi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hossein Akbari
Position
Prosthodontics resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Evin, daneshjoo Blvd
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2217 5350
Email
hosseinakbari@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All patients data including age,sex and results research will be shareable after making individuals undistinguishable
When the data will become available and for how long
As the same time as publishing results
To whom data/document is available
Researchers in academic and scientific intitutions
Under which criteria data/document could be used
Quantitative analyzes on the results are allowed
From where data/document is obtainable
Hossein Akbari 00989166645663
What processes are involved for a request to access data/document
After receiving e-mail from applicant,it will take up to one month to sent
documents.