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

NCT05548894 | Completed DMC

• 1 other identifier: A34080622
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

TMJ Disc Disorder

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

stabilization splint

ACTIVE COMPARATOR

acrylic splint in the maxillary arch with flat surface

Device: stabilization splint

laser therapy

ACTIVE COMPARATOR

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

Device: laser therapy

stabilization splint and laser therapy

ACTIVE COMPARATOR

using both laser therapy and stabilization splint for more improvement

Device: stabilization splint and laser therapy

Interventions

stabilization splint DEVICE

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

Also known as: upper acrylic full arch splint

stabilization splint

laser therapy 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

Also known as: Low-level laser therapy

laser therapy

stabilization splint and laser therapy DEVICE

the stabilization splint used in combination of treatment with laser therapy

Also known as: splint combined with low level laser therapy

stabilization splint and laser therapy

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• neurologic diseases
• TMJ pathologic lesions

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura university

Al Mansurah, Egypt

Location

Related Publications (3)

• 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.

  PMID: 23835639 BACKGROUND

• 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.

  PMID: 8638492 BACKGROUND

• 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.

  PMID: 36564950 DERIVED

MeSH Terms

Interventions

Laser Therapy; Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Phototherapy

Study Officials

• Noha Elshahid

  lecturer at mansoura university prosthodontic department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel clinical trial

Study Record Dates

• First Submitted: September 11, 2022
• First Posted: September 22, 2022
• Study Start: March 3, 2021
• Primary Completion: February 6, 2022
• Study Completion: March 6, 2022
• Last Updated: September 27, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)