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

TMJ Disc Disorder Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05548894
• Other study ID #: A34080622
• Status: Completed
• Phase: N/A
• Start date: March 3, 2021
• Est. completion date: March 6, 2022

Study information

• Verified date: August 2022
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: March 6, 2022
• Est. primary completion date: February 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of chronic closed lock patients

• Must not be able to open their mouth

Exclusion Criteria:

• neurologic diseases

• TMJ pathologic lesions

Related Conditions & MeSH terms

• TMJ Disc Disorder

Intervention

Device:
• stabilization splint
upper acrylic splint rest on the maxillary teeth and had flat surface
• laser therapy
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
• stabilization splint and laser therapy
the stabilization splint used in combination of treatment with laser therapy

Locations

Country	Name	City	State
Egypt	Mansoura university	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Ooi K, Yura S, Inoue N, Totsuka Y. Factors related to the incidence of anterior disc displacement without reduction and bony changes of the temporomandibular joint in patients with anterior open bite. Oral Maxillofac Surg. 2014 Dec;18(4):397-401. doi: 10.1007/s10006-013-0424-3. Epub 2013 Jul 9. — View Citation

Samdal F, Amland PF, Sandsmark M, Hall C, Aasen AO. Suction-assisted lipectomy does not increase the risk of random flap necrosis in a randomized study in pigs. Aesthetic Plast Surg. 1995 Nov-Dec;19(6):549-53. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	evaluation of mouth opening	improvement in mouth opening or not	6 months
Primary	Masticatory muscles palpation	the masticatory muscles were palpated bilaterally with firm and constant pressure of one kg lasted two seconds to define painful areas	6 months
Primary	temporomandibular joint palpation	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	6 months