Temporomandibular DisorderNCT05138354
Standard Care With LLLT & Myofascial Release Versus Standard Care Alone in Pregnant Women With Temporomandibular Disorder
A study testing Low Level laser therapy and Myofascial release in people with Temporomandibular Disorder, run by October 6 University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Temporomandibular Disorder
- What is being tested?
- Low Level laser therapy and Myofascial release
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Feb 2021to 26 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pregnant women diagnosed with myofascial TMD according to the Research Diagnostic Criteria for Temporomandibular Disorders
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site
October 6 University Hospital
Al Ḩayy Ath Thāmin, Giza Governorate, 12511
About this study
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
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
- Temporomandibular Disorder
- Being tested
- Low Level laser therapy, Myofascial release, Standard care
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Level laser therapyOther
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 releaseOther
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 careOther
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | 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. Receives: Other: Standard care |
| Intervention group | Experimental | 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 Receives: Other: Low Level laser therapy; Other: Myofascial release; Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and after 4 weeks
Changes in pain pressure threshold (PPT)
Comparing pain pressure threshold differences on both sides over TMJ, masseter and anterior temporalis.
Measured: Baseline and after 4 weeks
Secondary outcomes (1)
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
Measured: Baseline and after 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start18 Feb 2021
- Primary completion26 Oct 2021
- Study completion26 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Magdy Ali Hassan ElMeligie, October 6 University
- Investigators
- Radwa M Yehia, Ph.D, Study director, Faculty of Physical Therapy, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05138354
- Sponsor's protocol ID
- PTMD2021
- Status last verified
- Nov 2021
- First submitted
- 18 Nov 2021
- Last updated
- 1 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all of the individual participant data collected during the trial and after deidentification
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05138354
- Acronym / sponsor ID
- PTMD2021
- Conditions
- Temporomandibular Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 18 Feb 2021 (actual)
- Primary completion
- 26 Oct 2021 (actual)
- Study completion
- 26 Oct 2021 (actual)
- First posted
- 1 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Standard carePatients 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. |
| Intervention group | Experimental | Other: Low Level laser therapy, Other: Myofascial release, Other: Standard carePatients 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 |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Pregnant women diagnosed with myofascial TMD according to the Research Diagnostic Criteria for Temporomandibular Disorders
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low 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. | Other | Intervention group |
| Myofascial 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. | Other | Intervention group |
| Standard 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. | Other | Control group, Intervention group |
Primary outcome
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.
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.
1 secondary outcome
Limitations of daily function in temporomandibular disorder questionnaire
Time frame: Baseline and after 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2021.
- Individual participant dataSharing planned: Yes. all of the individual participant data collected during the trial and after deidentification
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Radwa M Yehia, Ph.D study director
Faculty of Physical Therapy, October 6 University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Level laser therapy and Myofascial release in people with Temporomandibular Disorder, run by October 6 University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in visual analogue scale (time frame: Baseline and after 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2021.