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

Temporomandibular Joint Disc Displacement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03057262
• Other study ID #: 122.6120.43.2016 BC
• Status: Completed
• Phase: N/A
• First received: February 15, 2017
• Last updated: March 19, 2017
• Start date: February 2014
• Est. completion date: December 2016

Study information

• Verified date: March 2017
• Source: Jagiellonian University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: December 2016
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. unilateral or bilateral presence of clicking, popping and/or snapping noise(s) detected with palpation during opening or closing or lateral or protrusive movements in TMJ(s),

2. in the previous 30 days, any TMJ noise(s) present with jaw movement or function,

3. unilateral or bilateral pain in the area of temporomandibular joint,

4. presence of masticatory muscles contracture,

5. full dentition or single tooth loss,

6. good general health,

7. positive mandible protrusion test,

8. no contraindications for laser therapy

9. patient consent to be involved in the study.

Exclusion Criteria:

1. partial tooth loss or edentulism,

2. contraindications for laser therapy

3. absence of appropriate symptoms

4. absence of consent to be involved in the study

Related Conditions & MeSH terms

• Temporomandibular Joint Disc Displacement

Intervention

Device:
• Repositioning splint
Application of repositioning splint in the study group.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jagiellonian University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain relief related to temporomandibular joint disc displacement with reduction	Repositioning splint was applied to check its efficiency of pain relieving in a case of temporomandibular joint disc displacement with reduction.	16 weeks