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Completed

NCT Number: NCT05138354

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

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.

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Key information

Conditions

Temporomandibular Disorder Craniomandibular Disorders Jaw Diseases Joint Diseases Mandibular Diseases Muscular Diseases Musculoskeletal Diseases Stomatognathic Diseases Temporomandibular Joint Disorders

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

October 6 University Hospital

Al Ḩayy Ath Thāmin, Giza Governorate, 12511, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low Level Laser Therapy

Other

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

Other

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

Other
  • 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 outcomes

  1. Changes in visual analogue scale

    Time frame: Baseline and after 4 weeks

    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.

  2. Changes in pain pressure threshold (PPT)

    Time frame: Baseline and after 4 weeks

    Comparing pain pressure threshold differences on both sides over TMJ, masseter and anterior temporalis.

Secondary outcomes

  1. Limitations of daily function in temporomandibular disorder questionnaire

    Time frame: Baseline and after 4 weeks

    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

Sponsors and collaborators

Lead sponsor

October 6 University

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 1, 2021
Registry last updated
Dec 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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