Clinical Trials Directory

Trials / Completed

CompletedNCT05138354

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
30 (actual)
Sponsor
October 6 University · Academic / Other
Sex
Female
Age
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERLow Level laser therapyMLS® 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.
OTHERMyofascial releasePatients 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.
OTHERStandard care1. 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.

Timeline

Start date
2021-02-18
Primary completion
2021-10-26
Completion
2021-10-26
First posted
2021-12-01
Last updated
2021-12-01

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT05138354. Inclusion in this directory is not an endorsement.