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

NCT ID: NCT05548894

Last Updated: 2022-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-03
• Study Completion Date: 2022-03-06

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.

Conditions

TMJ Disc Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

stabilization splint

acrylic splint in the maxillary arch with flat surface

Group Type: ACTIVE_COMPARATOR

stabilization splint

Intervention Type: DEVICE

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

laser therapy

laser beam directed to the affected part cause activation of blood circulation

Group Type: ACTIVE_COMPARATOR

laser therapy

Intervention Type: 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

stabilization splint and laser therapy

using both laser therapy and stabilization splint for more improvement

Group Type: ACTIVE_COMPARATOR

stabilization splint and laser therapy

Intervention Type: DEVICE

the stabilization splint used in combination of treatment with laser therapy

Interventions

stabilization splint

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

Intervention Type: DEVICE

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

Intervention Type: DEVICE

stabilization splint and laser therapy

the stabilization splint used in combination of treatment with laser therapy

Intervention Type: DEVICE

Other Intervention Names

upper acrylic full arch splint; Low-level laser therapy; splint combined with low level laser therapy

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Noha Elshahid

Role: PRINCIPAL_INVESTIGATOR

lecturer at mansoura university prosthodontic department

Locations

Mansoura university

Al Mansurah, , Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 23835639 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8638492 (View on PubMed)

El-Shaheed NH, Mostafa AZH, Aboelez MA. Efficacy of stabilisation splint and low-level laser therapy for patients with chronic closed lock from non-reducible displaced temporo-mandibular joint discs: A parallel randomised clinical trial. J Oral Rehabil. 2023 Mar;50(3):177-193. doi: 10.1111/joor.13405. Epub 2023 Jan 5.

Reference Type: DERIVED

PMID: 36564950 (View on PubMed)

Other Identifiers

A34080622

Identifier Type: -

Identifier Source: org_study_id