Clinical trial NCT05548894: Comparison Between Splint and Laser in Patients Without Disc Displacement With Reduction
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: TMJ Disc Disorder
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2022-09-22
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel clinical trial
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* neurologic diseases
* TMJ pathologic lesions

Primary outcomes:
measure: evaluation of mouth opening
timeFrame: 6 months
measure: Masticatory muscles palpation
timeFrame: 6 months
measure: temporomandibular joint palpation
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura university
Study officials:
affiliation: lecturer at mansoura university prosthodontic department
name: Noha Elshahid
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.1007/BF00454320.