Standard Care With LLLT & Myofascial Release Versus Standard Care Alone in Pregnant Women With Temporomandibular Disorder

Temporomandibular Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05138354
• Other study ID #: PTMD2021
• Status: Completed
• Phase: N/A
• Start date: February 18, 2021
• Est. completion date: October 26, 2021

Study information

• Verified date: November 2021
• Source: October 6 University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 26, 2021
• Est. primary completion date: October 26, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Temporomandibular Disorder
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Other:
• 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
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.

Locations

Country	Name	City	State
Egypt	October 6 University Hospital	Al ?ayy Ath Thamin	Giza

Sponsors (1)

Lead Sponsor	Collaborator
October 6 University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and after 4 weeks
Primary	Changes in pain pressure threshold (PPT)	Comparing pain pressure threshold differences on both sides over TMJ, masseter and anterior temporalis.	Baseline and after 4 weeks
Secondary	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	Baseline and after 4 weeks