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IRCT20180513039631N1 IRCT 2019-01-05 Mashhad University of Medical Sciences Comparison of the Effect of Different Thickness of Soft and Hard Occlusal Splints on Reducing Clinical Symptoms in Patients with Temporomandibular Joint Disorders 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 2018-05-31 anticipated 60 Complete https://irct.ir/trial/31232 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. N/A temporpmandibular disorders. Intervention 1: 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. Intervention 2: 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. Intervention 3: 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. Intervention 4: 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. Yes - There is a plan to make this available What will be shared: The total potential data can be shared after unidentifiable people When: Starting the access period from 2020 To whom: Researchers People who are engaged in the industry Conditions: Sending a request for access to data, or documentation and analyzes permissible on delivered data must be notified by email to the corresponding author Where to obtain: corresponding author, Mohammad Bagheri iraj, mohammad.b.iraj@gmail.com How to obtain: 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. Comments:
public Mohammad Bagheri Iraj
Vakil Abad, In front of Mellat Park, Faculty of Dentistry
Mashhad Iran (Islamic Republic of) 9177948959 +98 51 3882 9501 bagherimh951@mums.ac.ir Mashhad University of Medical Sciences scientific Azam sadat Madani
Vakil Abad, In front of Mellat Park, Faculty of Dentistry
Mashhad Iran (Islamic Republic of) 9177948959 +98 51 3882 9501 madania@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) 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. 18 years 50 years Both 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 M99 Biomechanical lesions, not elsewhere classified Treatment - Devices Treatment - Devices Treatment - Devices Treatment - Devices 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. 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. 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. 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. Pain score. Timepoint: before study, 7th, 30th, 90th day after Therapeutic intervention. Method of measurement: Visual Analogue Scale. Mashhad University of Medical Sciences Approved 2018-04-18 Ethics committee of Mashhad University of Medical Sciences Vakil Abad- In front of Mellat Park, Faculty of Dentistry mashhad Razavi Khorasan Iran (Islamic Republic of)