Standard Care With LLLT & Myofascial Release Versus Standard Care Alone in Pregnant Women With Temporomandibular Disorder
Primary Purpose
Temporomandibular Disorder
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Low Level laser therapy
Myofascial release
Standard care
Sponsored by
About this trial
This is an interventional treatment trial for Temporomandibular Disorder
Eligibility Criteria
Inclusion Criteria:
- Pregnant women diagnosed with myofascial TMD according to the Research Diagnostic Criteria for Temporomandibular Disorders
Exclusion Criteria:
- facial neuro-musculoskeletal pathologies (i.e., facial trauma and/or fractures, and bell's palsy)
- 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
Sites / Locations
- October 6 University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control group
Intervention group
Arm Description
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.
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
Outcomes
Primary Outcome Measures
Changes in visual analogue scale
Visual analog scale (VAS), a grading scale range from 0 to 100 mm. 0 mm represented no pain or discomfort at all and 100 mm represented the greatest amount of pain or discomfort imaginable. Participant drew a line that intersects the grading scale to show the amount of pain or discomfort that he or she experienced at that moment. The assessor then used a ruler to measure the length from 0 mm to the intersecting line and recorded the value.
Changes in pain pressure threshold (PPT)
Comparing pain pressure threshold differences on both sides over TMJ, masseter and anterior temporalis.
Secondary Outcome Measures
Limitations of daily function in temporomandibular disorder questionnaire
The limitations in daily functions in the temporomandibular disorder questionnaire (LDF-TMDQ) assess participants' functionality by asking them to report how much the jaw problem prevents or limits their performance in a list of 10 daily activities
Full Information
NCT ID
NCT05138354
First Posted
November 18, 2021
Last Updated
November 18, 2021
Sponsor
October 6 University
1. Study Identification
Unique Protocol Identification Number
NCT05138354
Brief Title
Standard Care With LLLT & Myofascial Release Versus Standard Care Alone in Pregnant Women With Temporomandibular Disorder
Official Title
Standard Care Combined With Low-Level Laser Therapy and Myofascial Release Versus Standard Care Alone in Pregnant Women With Temporomandibular Disorder: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
February 18, 2021 (Actual)
Primary Completion Date
October 26, 2021 (Actual)
Study Completion Date
October 26, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
October 6 University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will investigate a novel approach to treat pregnant women with tempromandibular disorder using a combined method of low level laser therapy, myofascial release and standard care versus standard care alone. It's hopeful that the results of this study can fill the gap of knowledge surrounding the conservative treatment options for TMD in order to help patients restore their oral function properly and promote new ways of addressing TMD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Low Level laser therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Myofascial release
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard care
Intervention Description
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.
Hot pack Participants will receive a warm water pack the TMJ and masticatory muscles for 10 minutes.
Exercise program:
Active exercises for mandibular muscles will be used to correct the mouth opening
Lateral movements of the jaw (3 sets of 10 repetitions).
Jaw relaxation exercise (3 sets of 10 repetitions).
Chin tuck (10 repetitions, holding 10s each).
Resisted opening of the mouth (3 sets of 10 repetitions).
Resisted closing of the mouth (3 sets of 10 repetitions).
Stretching exercise for mandibular muscles.
Primary Outcome Measure Information:
Title
Changes in visual analogue scale
Description
Visual analog scale (VAS), a grading scale range from 0 to 100 mm. 0 mm represented no pain or discomfort at all and 100 mm represented the greatest amount of pain or discomfort imaginable. Participant drew a line that intersects the grading scale to show the amount of pain or discomfort that he or she experienced at that moment. The assessor then used a ruler to measure the length from 0 mm to the intersecting line and recorded the value.
Time Frame
Baseline and after 4 weeks
Title
Changes in pain pressure threshold (PPT)
Description
Comparing pain pressure threshold differences on both sides over TMJ, masseter and anterior temporalis.
Time Frame
Baseline and after 4 weeks
Secondary Outcome Measure Information:
Title
Limitations of daily function in temporomandibular disorder questionnaire
Description
The limitations in daily functions in the temporomandibular disorder questionnaire (LDF-TMDQ) assess participants' functionality by asking them to report how much the jaw problem prevents or limits their performance in a list of 10 daily activities
Time Frame
Baseline and after 4 weeks
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pregnant women diagnosed with myofascial TMD according to the Research Diagnostic Criteria for Temporomandibular Disorders
Exclusion Criteria:
facial neuro-musculoskeletal pathologies (i.e., facial trauma and/or fractures, and bell's palsy)
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Radwa M Yehia, Ph.D
Organizational Affiliation
Faculty of Physical Therapy, October 6 University
Official's Role
Study Director
Facility Information:
Facility Name
October 6 University Hospital
City
Al Ḩayy Ath Thāmin
State/Province
Giza
ZIP/Postal Code
12511
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
all of the individual participant data collected during the trial and after deidentification
IPD Sharing Time Frame
6 Months after study publication
IPD Sharing Access Criteria
Email: mohamed.magdy.pt@o6u.edu.eg
Learn more about this trial
Standard Care With LLLT & Myofascial Release Versus Standard Care Alone in Pregnant Women With Temporomandibular Disorder
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