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

Not Applicable

Completed

• Conditions: TMJ Disc Disorder
• Interventions: Device: laser therapy; Device: stabilization splint and laser therapy; Device: stabilization splint

• Registration Number: NCT05548894
• Lead Sponsor: Mansoura University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2021-03-03
• Primary Completion: 2022-02-06
• Study Completion: 2022-03-06
• Status Verified: 2022-08
• Study First Submitted: 2022-09-11
• Study First Submitted QC: 2022-09-17
• Study First Posted: 2022-09-22
• Last Update Submitted: 2022-09-23
• Last Update Posted: 2022-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

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

Exclusion Criteria

• neurologic diseases
• TMJ pathologic lesions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
laser therapy	laser therapy	laser beam directed to the affected part cause activation of blood circulation
stabilization splint and laser therapy	stabilization splint and laser therapy	using both laser therapy and stabilization splint for more improvement
stabilization splint	stabilization splint	acrylic splint in the maxillary arch with flat surface

Primary Outcome Measures

Name	Time	Method
evaluation of mouth opening	6 months	improvement in mouth opening or not
temporomandibular joint palpation	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
Masticatory muscles palpation	6 months	the masticatory muscles were palpated bilaterally with firm and constant pressure of one kg lasted two seconds to define painful areas

Trial Locations

Locations (1)

Mansoura university; 🇪🇬 Mansoura, Egypt