Comparison of the Effect of Different Thickness of Soft and Hard Occlusal Splints on Reducing Clinical Symptoms in Patients with Temporomandibular Joint Disorders Referring to the Occlusion department of Mashhad Dental School in 1397
Comparison of the Effect of Different Thickness of Soft and Hard Occlusal Splints on Reducing Clinical Symptoms in Patients with Temporomandibular Joint Disorders Referring to the Occlusion department of Mashhad Dental School in 1397
Design
The randomization method will be in this way: a packet of 60 numbers will be given to the secretary. The patient and the secretary do not know what treatment method is for each number. The patient chooses a therapeutic approach by receiving a secretary's number.
Settings and conduct
In this study, 60 patients from Mashhad Dental School who have Criteria for entering/ exiting study and matched for age and sex are randomly assigned to the four groups.
In this study, before splint application, after 1 week, 1 month and 3 months, patients will be examined for pain and maximal oral opening. In the Visual Analogue Scale (VAS), the patient is given a score of 0 to 10 points to assess the pain depending on the behavior, movements, state, and...
Blinding in this study is not feasible due to the goals and method of implementation, but in order to avoid the bias in the outcome, the patients' follow up is done by the executor of the project that does not know the type of treatment for each patient.
Participants/Inclusion and exclusion criteria
Patients referring to the Department of Occlusion at Mashhad Dental School who completed the informed consent form
Patients with RDC1 and RDC3 with pain based RDC/TMD
Patients over the age of 18 and under age 50
Skeletal Class 1 Patients
History of trauma in the last 3 months has not been to the joint, face or neck.
Intervention groups
soft occlusal splint 1 mm thickness
soft occlusal splint 3 mm thickness
hard occlusal splint 1 mm thickness
hard occlusal splint 3 mm thickness
Main outcome variables
Pain score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180513039631N1
Registration date:2019-01-05, 1397/10/15
Registration timing:registered_while_recruiting
Last update:2019-01-05, 1397/10/15
Update count:0
Registration date
2019-01-05, 1397/10/15
Registrant information
Name
mohammad bagheri Iraj
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3804 9292
Email address
bagherimh951@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-31, 1397/03/10
Expected recruitment end date
2019-05-31, 1398/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of Different Thickness of Soft and Hard Occlusal Splints on Reducing Clinical Symptoms in Patients with Temporomandibular Joint Disorders Referring to the Occlusion department of Mashhad Dental School in 1397
Public title
Comparison of the Effect of Different Thickness of Soft and Hard Occlusal Splints on Reducing Clinical Symptoms in Patients with Temporomandibular Joint Disorders
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients referring to the Department of Occlusion at Mashhad Dental School who completed the informed consent form
Patients with RDC1 and RDC3 with pain based RDC/TMD
Patients over the age of 18 and under age 50
skeletal Class 1 Patients
history of trauma in the last 3 months has not been to the joint, face or neck.
Exclusion criteria:
Patients with uncontrolled systemic disease
Patients with nerve disorders, head and neck cancer
Edentulous patients
Patients with history of TMJ surgery
Patients with idiopathic clinical symptoms
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method will be in this way, a packet with 60 number, available to the secretary.The patient and the secretary do not know what numbers are for study groups. The patient chooses a therapeutic approach by receiving a number.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, participants do not know the type of treatment they were given include thickness and the type of occlusal splints.A researcher who is responsible for the patient's fallow up do not Know type of treatment for each patient. Also, data analyzer do not aware from the study groups and the type of treatment received by each patient.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Vakil Abad- In front of Mellat Park, Faculty of Dentistry
City
mashhad
Province
Razavi Khorasan
Postal code
9177948959
Approval date
2018-04-18, 1397/01/29
Ethics committee reference number
IR.MUMS.DENTISTRY.REC.1397.002
Health conditions studied
1
Description of health condition studied
temporpmandibular disorders
ICD-10 code
M99
ICD-10 code description
Biomechanical lesions, not elsewhere classified
Primary outcomes
1
Description
Pain score
Timepoint
before study, 7th, 30th, 90th day after Therapeutic intervention
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: soft occlusal splint 1 mm thickness. The criterion for making occlusal splints is in this way: at first, the distance between the lower right central incisor cervical point (if its absence, use lower left central incisor) and incisal edge right upper central incisor is measured in the absence of splint. then, with occlusal splints, the distance is re-measured. Soft occlusal splints with 1 mm thickness are made of elastic rubbery sheets with a thickness of 1 mm. In this study, before splint application, after 1 week, 1 month and 3 months, patients will be examined for pain and maximal oral opening.
Category
Treatment - Devices
2
Description
Intervention group: soft occlusal splint 3 mm thickness. The criterion for making occlusal splints is in this way: at first, the distance between the lower right central incisor cervical point (if its absence, use lower left central incisor) and incisal edge right upper central incisor is measured in the absence of splint. then, with occlusal splints, the distance is re-measured. Soft occlusal splints with 3 mm thickness are made of elastic rubbery sheets with a thickness of 3 mm. In this study, before splint application, after 1 week, 1 month and 3 months, patients will be examined for pain and maximal oral opening.
Category
Treatment - Devices
3
Description
Intervention group: hard occlusal splint 1 mm thickness.The criterion for making occlusal splints is in this way: at first, the distance between the lower right central incisor cervical point (if its absence, use lower left central incisor) and incisal edge right upper central incisor is measured in the absence of splint. then, with occlusal splints, the distance is re-measured. Hard occlusal splints are made of acrylic resin with 1 mm thickness. In this study, before splint application, after 1 week, 1 month and 3 months, patients will be examined for pain and maximal oral opening.
Category
Treatment - Devices
4
Description
Intervention group: hard occlusal splint 3 mm thickness. The criterion for making occlusal splints is in this way: at first, the distance between the lower right central incisor cervical point (if its absence, use lower left central incisor) and incisal edge right upper central incisor is measured in the absence of splint. then, with occlusal splints, the distance is re-measured. Hard occlusal splints are made of acrylic resin with 3 mm thickness. In this study, before splint application, after 1 week, 1 month and 3 months, patients will be examined for pain and maximal oral opening.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry, Mashhad University of Medical Sciences
Full name of responsible person
Azam Sadat Madani
Street address
Vakil Abad, In front of Mellat Park, Faculty of Dentistry
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9501
Email
madania@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Vakil Abad- In front of Mellat Park, Faculty of Dentistry
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3841 2081
Email
vcresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Bagheri Iraj
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Vakil Abad, In front of Mellat Park, Faculty of Dentistry
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9501
Email
bagherimh951@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Azam sadat Madani
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Vakil Abad, In front of Mellat Park, Faculty of Dentistry
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9501
Email
madania@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Bagheri Iraj
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Vakil Abad, In front of Mellat Park, Faculty of Dentistry
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9501
Email
bagherimh951@mums.ac.ir
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
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
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
The total potential data can be shared after unidentifiable people
When the data will become available and for how long
Starting the access period from 2020
To whom data/document is available
Researchers
People who are engaged in the industry
Under which criteria data/document could be used
Sending a request for access to data, or documentation and analyzes permissible on delivered data must be notified by email to the corresponding author
From where data/document is obtainable
corresponding author, Mohammad Bagheri iraj, mohammad.b.iraj@gmail.com
What processes are involved for a request to access data/document
Sending a request for access to data, or documentation must be notified by email to the corresponding author
We try to provide the data applicant in less than a month to the requesting researcher.