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IRCT20211205053279N2 IRCT 2022-12-07 Shahid Beheshti University of Medical Sciences Effect of Physiotherapy on Maximum Mouth Opening after Surgery Evaluation of The Effect of Transcutaneous Electrical Nerve Stimulation (TENS) on Maximum Mouth Opening (MMO) after Orthognathic Surgery 2022-03-03 anticipated 82 Complete https://irct.ir/trial/62254 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomized blocks method classified by age and sex The randomized block design takes account of known factors that affect outcome but are not of primary interest. The two steps in randomized block design are: 1. Collect together homogeneous experimental units (e.g.sex) into a block 2.Assign treatments at random to the experimental units within a block. Homogeneous patients, for example 20-25 years old men are placed in a block of four. For each block we will have 6 modes:(i:intervention c:control) I I C C I C I C I C C I C C I I C I C I C I I C By throwing a dice for each block, it is determined how patients enter the intervention and control group. N/A Maximum Mouth Opening (MMO) after Orthognathic Surgery. Intervention 1: Intervention group: TENS physiotherapy.3 sessions a week for a month starting the day after surgery,12 sessions in total. TENS, or transcutaneous electrical nerve stimulation, is a category of electrical modalities that is used in physiotherapy to treat pain, inflammation, muscle spasms, weakness, and other neuromuscular disorders. The electrodes of the device are placed on the healthy skin in the surgical area bilaterally, high and low frequency stimulations start in standard parameters in terms of frequency, duration and pulsed width. Traditional TENS requirements: Frequency of 150Hz, pulse width of 20 microseconds, pulse intensity starts from 10-30 mA and will be adjusted exclusively for each individual to the maximum tolerance threshold (but to the extent that the patient is comfortable). The pulses are Quadratic Biphasic Symmetrical and the modulation of up to 50% of the frequency variation and time of each session will be 45 minutes. Maximum Mouth Opening (The distance between the edges of the upper and lower incisors) will be measured by a digital caliper once before surgery as a baseline and then 1 and 6 months after surgery, recording and evaluation will be performed. Intervention 2: Control group: no interventions. Maximum Mouth Opening (The distance between the edges of the upper and lower incisors) will be measured by a digital caliper once before surgery as a baseline and then 1 and 6months after surgery. Recording and evaluation will be performed. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No further information
public Mostafa Alam
Velenjak St. , Shahid Chamran Highway,
Tehran Iran (Islamic Republic of) 1983969411 +98 21 2217 5350 mostafa_alam1@yahoo.com Shahid Beheshti University of Medical Sciences scientific Mostafa Alam
Velenjak St. , Shahid Chamran Highway,
Tehran Iran (Islamic Republic of) 1983969411 +98 21 2217 5350 mostafa_alam1@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Skeletal class III patients candidates for lefort I osteotomy maxillary advancement and BSSO(Bilateral Sagittal Split Osteaotomy) mandibular setback with Dalpont method no limit no limit Both Pathologic lesions around surgical areas History of jaw movements limitation Taking medicine due to mental problems History of jaw fracture Previous jaw surgery If maxillary advancement or mandibular setback is more than 6 millimeters Surgeries longer than 6 hours Bad split and work related injuries Simultaneous Genioplasty Patients who need further maxillofacial surgery after Orthognathic surgery Patients who have heart pacemaker Patients with epilepsy Patients with CVA history Rehabilitation Other Intervention group: TENS physiotherapy.3 sessions a week for a month starting the day after surgery,12 sessions in total. TENS, or transcutaneous electrical nerve stimulation, is a category of electrical modalities that is used in physiotherapy to treat pain, inflammation, muscle spasms, weakness, and other neuromuscular disorders. The electrodes of the device are placed on the healthy skin in the surgical area bilaterally, high and low frequency stimulations start in standard parameters in terms of frequency, duration and pulsed width. Traditional TENS requirements: Frequency of 150Hz, pulse width of 20 microseconds, pulse intensity starts from 10-30 mA and will be adjusted exclusively for each individual to the maximum tolerance threshold (but to the extent that the patient is comfortable). The pulses are Quadratic Biphasic Symmetrical and the modulation of up to 50% of the frequency variation and time of each session will be 45 minutes. Maximum Mouth Opening (The distance between the edges of the upper and lower incisors) will be measured by a digital caliper once before surgery as a baseline and then 1 and 6 months after surgery, recording and evaluation will be performed. Control group: no interventions. Maximum Mouth Opening (The distance between the edges of the upper and lower incisors) will be measured by a digital caliper once before surgery as a baseline and then 1 and 6months after surgery. Recording and evaluation will be performed. Maximum mouth opening. Timepoint: Before surgery , 1 month after surgery ,6 months after surgery. Method of measurement: Digital caliper. Shahid Beheshti University of Medical Sciences Approved 2022-02-12 Research Ethics Committee of Dental Sciences Shahid Beheshti University of Medical Sciences 10th Unit , No 6 , 36th Street , Usefabad Ave Tehran Tehran Iran (Islamic Republic of)