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Temporomandibular DysfunctionNCT06772012

Effectiveness of Low-Level Laser Therapy (LLLT) Versus Orofacial Physical Therapy for Temporomandibular Dysfunction. A Randomized Controlled Trial

A study testing Low-Level Laser Therapy (LLLT) and Orofacial Physical Therapy in people with Temporomandibular Dysfunction, run by Bahria University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will investigate if Low-Level Laser Therapy (LLLT) is more effective than Orofacial Physical Therapy for treating Temporomandibular Dysfunction. By conducting a randomized controlled trial, it aims to fill gaps in current knowledge, improve TMD treatment options, and enhance patient outcomes. Read more about this study

Who is it for?
Ages 30 years and olderHealthy volunteers can take part
Conditions the study is for
Temporomandibular Dysfunction
What is being tested?
Low-Level Laser Therapy (LLLT) and Orofacial Physical Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 sitePakistan
Study dates
1 Sep 2023to 2 Dec 2024
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 30 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 1) limited mouth opening or function(49) 2) presence of pain in masticatory muscles and/or TMJs(49) 3) muscular disturbance (49) 4) arthralgia(49)

Who cannot join

  • 1) major systemic disorders (49) 2) who received analgesic or anti-depressants over the last 2 weeks(49) 3) had any bony abnormalities of the jaws (49) 4) psychological illness (49) 5) pregnant and feeding women (49)

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Bahria University

    Karachi, 75500

Other trials in Pakistan

About this study

Official title: Effectiveness of Low-Level Laser Therapy (LLLT) Versus Orofacial Physical Therapy for Temporomandibular Dysfunction. A Randomized Controlled Trial.

This study will investigate if Low-Level Laser Therapy (LLLT) is more effective than Orofacial Physical Therapy for treating Temporomandibular Dysfunction. By conducting a randomized controlled trial, it aims to fill gaps in current knowledge, improve TMD treatment options, and enhance patient outcomes.

Read the detailed description

In the last 30 years, many nonsurgical therapies have been suggested for the treatment of temporomandibular disorders (TMD), including physical therapy, pharmacologic therapy, occlusal splints, occlusal adjustment, acupuncture, and low-level laser therapy (LLLT). (1) The main objective of all these treatment modalities is to reduce symptom intensity, thereby improving the function of the masticatory system and adjacent structures.(2) Signs and symptoms of TMD are present in 86% of the population, being more frequent among women, also related to dental occlusion and emotional stress. Are considered signs: limited mouth opening, joint sounds and deviation of the mandible to one side during opening and closing, muscle spasm, pain reflex, impaired joint motion, crepitus, headache and hearing disorders. Otologic symptoms are represented by decreased hearing, vertigo and tinnitus, which can be related to the ontogenetic and anatomical relationship between the middle ear and masticatory structures.(3) Among nonsurgical treatments, LLLT has increased in interest in the last few years, probably due to its ease of use in combination with reports of positive effects on pain alleviation. (4) LLLT is a non-thermal type of light, which causes internal changes in cells and tissues, leading to different types of metabolic activations. (5) These include stimulation of the cellular respiratory chain and increase in vascularization and fibroblast formation which have been suggested to play an important role in the analgesic effect of LLLT. Despite the fact that there is no universally accepted theory to explain the mechanism of either "laser analgesia" or "laser bio stimulation,"(6) LLLT can be expected to promote some anti-inflammatory effect and pain relief in painful and dysfunctional joints and muscles.(7) The most clinically used LLLT include the helium-neon laser (632 nm He-Ne) and infrared laser, as diode-gallium-arsenide (904 nm Ga-As) or gallium-aluminium-arsenide (830 nm Ga-Al-As). The mechanism of pain relief via mid-laser therapy is not clearly understood and several theories have been suggested. One theory considers the analgesic effect to be a consequence of the reduction of levels of prostaglandin E2 (PGE2 ), which is one of the most important proinflammatory mediators. This theory is based on in vivo and in vitro findings of a reduction of PGE2 both in cultures of ligament cells and in the joint capsule of animals after laser exposure. The PGE2 reduction probably derives from the inhibition made by laser radiation of cyclooxygenase-2 (COX-2), the enzyme involved in the synthesis of PGE.(8, 9) Another theory takes into account the effect of laser therapy on neuronal cells: The effect involves the possible selective inhibition of nociceptive signals16 and the microcirculation regulation; this action could interrupt the origin and development of pain and thus could provide analgesic effects.17,18 The magnitude of the laser effect seems to depend on the wavelength and dosage of the laser light.11 It has been reported that reduction of PGE2 could be observed within a range of dose between 0.4 and 19 J and within a range of power density between 5 and 21.2 mW/cm2 . (10)

Temporomandibular disorders (TMDs) are probably the most common cause of pain of non-dental origin in the maxillofacial area. The category of TMDs embraces a number of clinical problems related to masticator muscles, temporomandibular joint (TMJ) and associated structures, or both. (11) Such disorders are characterised by pain, joint sounds, and restricted mandibular movement. The incidence of TMD ranges from 40 to 75 % in general populations and approximately 65 % of affected patients experience associated pain. This great number of patients is treated using different modalities, depending on the aetiology of signs and symptoms. Conservative, rather than aggressive and irreversible, treatment is preferred to relieve symptoms, diminish pain, and re-establish function. (12, 13) As the aetiology of TMD is multifactorial, available treatments are extensive and diverse, including the use of occlusal splints, low-level laser therapy (LLLT), and transcutaneous electrical nerve stimulation, among many others. Given that better therapeutic results (i.e. pain relief ) are obtained with the combined use of modalities, several recent studies have examined the use of LLLT to reduce TMD pain and promote bio augmentation effects. (14) The LLT has demonstrated an ability to assist in the symptomatic treatment of pain, providing a considerable degree of comfort to the patient after application. The great advantage of laser applications in the treatment of TMD is that it is a non-invasive therapy, with low cost, and currently has being widely used in dental practice, reducing the demand related to the surgery or the use of drugs to treat relief pain and tissue regeneration.(15) The application of laser therapy in TMD patients has demonstrated an ability to relieve pain in few minutes after application, promoting well-being significant. However, LLT is an adjuvant treatment in pain relief by its analgesic action, which allows the patient's return to daily chores, providing comfort and better quality of life.(16) The G1 group was randomly divided into 7 therapeutic groups in which the therapy was carried out for 10 days: magneto stimulation (T1), magnetoledotherapy (T2), magnetolaserotherapy (T3), manual therapy- positional release and therapeutic exercises (T4), manual therapy - massage and therapeutic exercises (T5), manual therapy - PIR and therapeutic exercises (T6), self therapy - therapeutic exercises (T7).G2 was given LLLT. (17) Most people can open their mouth 35 to 55 millimeters (1.4 to 2.2 inches), which is about the width of 3 fingers (see Figure 2). Figure 2. Normal width of an open mouth Your jaw is made up of a pair of bones that form the framework of your mouth and teeth.(18)

This study will investigate if Low-Level Laser Therapy (LLLT) is more effective than Orofacial Physical Therapy for treating Temporomandibular Dysfunction. By conducting a randomized controlled trial, it aims to fill gaps in current knowledge, improve TMD treatment options, and enhance patient outcomes.

Being tested
Low-Level Laser Therapy (LLLT), Orofacial Physical Therapy
Keywords
temporomandibular dysfunction
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 Therapy (LLLT)Other

    • Frequency: LLLT was administered 3 times per week.
    • Duration: Each session lasted approximately 15-20 minutes.
    • Total Duration: The therapy was provided for a total of 6 weeks.(50)
  • Orofacial Physical TherapyOther

    • Frequency: Orofacial physical therapy sessions were conducted 3 times per week.
    • Duration: Each session lasted around 30-40 minutes.
    • Total Duration: The therapy was provided for a total of 6 weeks.
    • Components:
    • Manual Therapy: Included techniques such as joint mobilization, soft tissue manipulation, and muscle stretching.
    • Therapeutic Exercises: Focused on strengthening, coordination, and improving mobility of the masticatory muscles.
    • Postural Training: Addressed poor posture and cervical muscle spasm.(50)
Study groups in NCT06772012
Study groupRoleWhat they receive
Low-Level Laser Therapy (LLLT)ExperimentalIntervention Protocol: * Frequency: LLLT was administered 3 times per week. * Duration: Each session lasted approximately 15-20 minutes. * Total Duration: The therapy was provided for a total of 6 weeks.(50)
Receives: Other: Low-Level Laser Therapy (LLLT)
Orofacial Physical TherapyActive comparatorIntervention Protocol: * Frequency: Orofacial physical therapy sessions were conducted 3 times per week. * Duration: Each session lasted around 30-40 minutes. * Total Duration: The therapy was provided for a total of 6 weeks. * Components: * Manual Therapy: Included techniques such as joint mobilization, soft tissue manipulation, and muscle stretching. * Therapeutic Exercises: Focused on strengthening, coordination, and improving mobility of the masticatory muscles. * Postural Training: Addressed poor posture and cervical muscle spasm.(50)
Receives: Other: Orofacial Physical Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. jaw range of motion

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2025
  2. Study start1 Sep 2023
  3. Primary completion30 Sep 2024
  4. Study completion2 Dec 2024

Resources

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
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06772012
Sponsor's protocol ID
SU92-MSRSW-F22-085
Status last verified
Jan 2025
First submitted
8 Jan 2025
Last updated
13 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Petrucci A, Sgolastra F, Gatto R, Mattei A, Monaco A. Effectiveness of low-level laser therapy in temporomandibular disorders: a systematic review and meta-analysis. J Orofac Pain. 2011 Fall;25(4):298-307.

    PubMed 22247925

Questions about this trial

What is this clinical trial studying?

A study testing Low-Level Laser Therapy (LLLT) and Orofacial Physical Therapy in people with Temporomandibular Dysfunction, run by Bahria University at 1 site in Pakistan.

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 1 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 13 Jan 2025. 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 Pakistan. 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?

jaw range of motion (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06772012, which also lists 1 linked publication.

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 13 Jan 2025.

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