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Completed

NCT Number: NCT05548894

Comparison Between Splint and Laser in Patients Without Disc Displacement With Reduction

Stabilization splint therapy and Low-level laser therapy may serve as non-invasive intervention for painful temporomandibular disorders, but its efficacy is still debated. This study compared the effect of stabilization splint and low-level laser therapy alone or in combination in patients with painful chronic closed lock of temporomandibular joints disc displacement without Reduction 42 patients diagnosed with chronic closed lock of disc displacement without reduction were allocated equally and randomly into three treatment groups: group I received combined stabilization splint and low- level laser therapy, group II received low - level laser therapy and group III received stabilization splint. They were evaluated at baseline and one week, two weeks, four weeks, three months, and six months after the intervention.

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Key information

Conditions

TMJ Disc Disorder

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura university

Al Mansurah, Egypt

About this study

Objectives: Stabilization splint therapy and low- level laser therapy may serve as non-invasive intervention for painful temporomandibular disorders, but its efficacy is still debated. This study compared the effect of stabilization splint and low- level laser therapy alone or in combination in patients with painful chronic closed lock of temporomandibular joints disc displacement without Reduction.

Patients and methods: 42 patients diagnosed with chronic closed lock of disc displacement without reduction were allocated equally and randomly into three treatment groups: group I received combined stabilization splint and low-level laser therapy, group II received low-level laser therapy and group III received stabilization splint. They were evaluated at baseline and one week, two weeks, four weeks, three months, and six months after the intervention. Time of being normal was also evaluated.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Clinical diagnosis of chronic closed lock patients
  • Must not be able to open their mouth

Exclusion criteria

  • neurologic diseases
  • TMJ pathologic lesions

Treatment and study plan

stabilization splint

Device

upper acrylic splint rest on the maxillary teeth and had flat surface

Other names: upper acrylic full arch splint

Laser Therapy

Device

The laser apparatus had a hand piece on which either a specially designed optic prism was attached to transfer laser energy to the tip of the prism

Other names: Low-level laser therapy

stabilization splint and laser therapy

Device

the stabilization splint used in combination of treatment with laser therapy

Other names: splint combined with low level laser therapy

Primary outcomes

  1. evaluation of mouth opening

    Time frame: 6 months

    improvement in mouth opening or not

  2. Masticatory muscles palpation

    Time frame: 6 months

    the masticatory muscles were palpated bilaterally with firm and constant pressure of one kg lasted two seconds to define painful areas

  3. temporomandibular joint palpation

    Time frame: 6 months

    joint pain was achieved by first palpating the temporomandibular joint lateral pole by placing the index finger with firm and constant pressure of half kg lasted

    two seconds over the condyle in front of the tragus

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Comparison Between the Efficacy of Stabilization Splint and Low Level Laser Therapy for Treatment of Patients With Chronic Closed Lock of the Non-reducible Temporo-mandibular Joint Disc. A Parallel Randomized Clinical Trial.

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 22, 2022
Registry last updated
Sep 27, 2022

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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