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

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.

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.

Study Overview

• Status: Completed
• Conditions: TMJ Disc Disorder
• Intervention / Treatment: Device: stabilization splint; Device: laser therapy; Device: stabilization splint and laser therapy

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 Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Mansoura, Egypt
    • Mansoura University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: stabilization splint; acrylic splint in the maxillary arch with flat surface	Device: stabilization splint; upper acrylic splint rest on the maxillary teeth and had flat surface; Other Names: upper acrylic full arch splint
Active Comparator: laser therapy; laser beam directed to the affected part cause activation of blood circulation	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; Other Names: Low-level laser therapy
Active Comparator: stabilization splint and laser therapy; using both laser therapy and stabilization splint for more improvement	Device: stabilization splint and laser therapy; the stabilization splint used in combination of treatment with laser therapy; Other Names: splint combined with low level laser therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
evaluation of mouth opening	improvement in mouth opening or not	6 months
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
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

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Principal Investigator: Noha Elshahid, lecturer at mansoura university prosthodontic department

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2021
• Primary Completion (Actual): February 6, 2022
• Study Completion (Actual): March 6, 2022

Study Registration Dates

• First Submitted: September 11, 2022
• First Submitted That Met QC Criteria: September 17, 2022
• First Posted (Actual): September 22, 2022

Study Record Updates

• Last Update Posted (Actual): September 27, 2022
• Last Update Submitted That Met QC Criteria: September 23, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: A34080622

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No