NCT03057262

The Efficiency of Anterior Repositioning Splint for the Management of Temporomandibular Joint Dysunction

The Efficiency of Anterior Repositioning Splint for the Management of Pain Related to Temporomandibular Joint Disc Displacement With Reduction

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 112 (actual)
• Sponsor: Jagiellonian University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Intra-articular temporomandibular disorders are often related to pain in the area of temporomandibular joint, ear and temple. The aim of the study was to investigate the efficiency of anterior repositioning splints for the management of pain related to temporomandibular joint disc displacement with reduction.

Detailed description

The research material consisted of 112 patients, aged 24 to 45 years, of both genders, who reported to the treatment in Consulting Room of Temporomandibular Joint Dysfunctions at the Jagiellonian University in Cracow, between 2014-2016, due to the pain and clicking of temporomandibular joints with comorbid hypertension of masticatory muscles. Subjects were examined according to the Diagnostic Criteria for Temporomandibular Disorders protocol and after inclusion with painful disc displacement with reduction and masticatory muscle contracture assigned randomly to the study or control group (56 patients in each). In the study group was used the anterior repositioning splint on the lower arch for 20 hour usage per 4 months. In the control group a non-invasive therapy was applied using biostimulation laser in the form of 12 session, performed every second day, on the area of the temporomandibular joints with opened mouth and performing muscles self-exercises with a dominant protrusive position of the mandible. Pain intensity was evaluated using verbal numerical rating scale (VNRS) immediately before the treatment and then after 4 and 16 weeks. The obtained data were analyzed using U Mann-Whitney test (p ≤ 0,005).

Conditions

• Temporomandibular Joint Disc Displacement

Interventions

Type	Name	Description
DEVICE	Repositioning splint	Application of repositioning splint in the study group.

Timeline

• Start date: 2014-02-01
• Primary completion: 2014-02-01
• Completion: 2016-12-01
• First posted: 2017-02-20
• Last updated: 2017-03-21

Regulatory

• FDA-regulated device study