Standard Care With LLLT & Myofascial Release Versus Standard Care Alone in Pregnant Women With Temporomandibular Disorder
NCT ID: NCT05138354
Last Updated: 2021-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2021-02-18
2021-10-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Control group
Patients received a 4-week treatment program (12 treatment sessions, three times a week). Patients received the conservative treatment protocol comprised of ultrasound, hot pack application, and exercises.
Standard care
1. Ultrasound Participants will receive an application of pulsed ultrasound at a frequency of 3 MHz and an intensity of 0.5 W/cm² with a 1:1 duty cycle over TMJ for six minutes.
2. Hot pack Participants will receive a warm water pack the TMJ and masticatory muscles for 10 minutes.
3. Exercise program:
Active exercises for mandibular muscles will be used to correct the mouth opening
1. Lateral movements of the jaw (3 sets of 10 repetitions).
2. Jaw relaxation exercise (3 sets of 10 repetitions).
3. Chin tuck (10 repetitions, holding 10s each).
4. Resisted opening of the mouth (3 sets of 10 repetitions).
5. Resisted closing of the mouth (3 sets of 10 repetitions).
6. Stretching exercise for mandibular muscles.
Intervention group
Patients received a 4-week treatment program (12 treatment sessions, three times a week). Patients received LLLT and myofascial release combined with the control intervention. the conservative treatment protocol comprised of ultrasound, hot pack application, and exercises
Low Level laser therapy
MLS® device (ASA Srl, Vicenza, Italy) IR laser with two synchronized sources (laser diodes) and a wavelength of 808 nm to deliver the intervention. The laser probe will be held vertically in contact with the skin to deliver the irradiation at three mandibular condyle points (front, behind and over) and one point at the external acoustic meatus. The irradiation will be applied with a laser bean of 3.14 cm² diameter for 14 seconds at each place using a pulse rate of 1500 Hz, pulse duration of 100ns, and energy density: 16 J/cm².
Myofascial release
Patients will be positioned in supine in a treatment table. The therapist seated beside the patient at the side of affected temporomandibular joint to apply gross release technique for masseter, pterygoid and temporalis muscles. At each point, the therapist applied the technique for 90 seconds and repeated 5 times during the session (5 seconds of rest between each repetition).(15) The therapist worn gloves to deliver the intraoral myofascial release. In case the patient reported any latex allergies, the gloves were replaced by a latex free model.
Standard care
1. Ultrasound Participants will receive an application of pulsed ultrasound at a frequency of 3 MHz and an intensity of 0.5 W/cm² with a 1:1 duty cycle over TMJ for six minutes.
2. Hot pack Participants will receive a warm water pack the TMJ and masticatory muscles for 10 minutes.
3. Exercise program:
Active exercises for mandibular muscles will be used to correct the mouth opening
1. Lateral movements of the jaw (3 sets of 10 repetitions).
2. Jaw relaxation exercise (3 sets of 10 repetitions).
3. Chin tuck (10 repetitions, holding 10s each).
4. Resisted opening of the mouth (3 sets of 10 repetitions).
5. Resisted closing of the mouth (3 sets of 10 repetitions).
6. Stretching exercise for mandibular muscles.
Interventions
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Low Level laser therapy
MLS® device (ASA Srl, Vicenza, Italy) IR laser with two synchronized sources (laser diodes) and a wavelength of 808 nm to deliver the intervention. The laser probe will be held vertically in contact with the skin to deliver the irradiation at three mandibular condyle points (front, behind and over) and one point at the external acoustic meatus. The irradiation will be applied with a laser bean of 3.14 cm² diameter for 14 seconds at each place using a pulse rate of 1500 Hz, pulse duration of 100ns, and energy density: 16 J/cm².
Myofascial release
Patients will be positioned in supine in a treatment table. The therapist seated beside the patient at the side of affected temporomandibular joint to apply gross release technique for masseter, pterygoid and temporalis muscles. At each point, the therapist applied the technique for 90 seconds and repeated 5 times during the session (5 seconds of rest between each repetition).(15) The therapist worn gloves to deliver the intraoral myofascial release. In case the patient reported any latex allergies, the gloves were replaced by a latex free model.
Standard care
1. Ultrasound Participants will receive an application of pulsed ultrasound at a frequency of 3 MHz and an intensity of 0.5 W/cm² with a 1:1 duty cycle over TMJ for six minutes.
2. Hot pack Participants will receive a warm water pack the TMJ and masticatory muscles for 10 minutes.
3. Exercise program:
Active exercises for mandibular muscles will be used to correct the mouth opening
1. Lateral movements of the jaw (3 sets of 10 repetitions).
2. Jaw relaxation exercise (3 sets of 10 repetitions).
3. Chin tuck (10 repetitions, holding 10s each).
4. Resisted opening of the mouth (3 sets of 10 repetitions).
5. Resisted closing of the mouth (3 sets of 10 repetitions).
6. Stretching exercise for mandibular muscles.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* acute infections or systemic disorders
* osteoporosis
* cervical spine or upper limb dysfunction
* steroid infiltration4
* any recent dental treatment taken or surgery over TMJ
* hypermobile joint
* neurological impairments
FEMALE
No
Sponsors
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October 6 University
OTHER
Responsible Party
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Mohamed Magdy Ali Hassan ElMeligie
Principal investigator
Principal Investigators
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Radwa M Yehia, Ph.D
Role: STUDY_DIRECTOR
Faculty of Physical Therapy, October 6 University
Locations
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October 6 University Hospital
Al Ḩayy Ath Thāmin, Giza Governorate, Egypt
Countries
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Other Identifiers
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PTMD2021
Identifier Type: -
Identifier Source: org_study_id