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

NCT ID: NCT03057262

Last Updated: 2017-03-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 112 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2016-12-31

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Study group

Study group consisted of 56 subjects of both genders with unilateral or bilateral disc displacement(s) with reduction and pain in the area of temporomandibular joint. Patients were recruited from the Consulting Room of Temporomandibular Joint Dysfunction at the Jagiellonian University in Krakow during the years 2014-2016. In the study group was used the typical acrylic anterior repositioning splint fabricated in tete-a-tete (incisal) jaws position, covered the lower teeth arch to recapture a displaced disc(s) and decrease the intensity of pain. The anterior repositioning splint was recommended to 20 - hour use for a period of four months.

Repositioning splint

Intervention Type: DEVICE

Application of repositioning splint in the study group.

Control group

Control group consisted of 56 subjects of both genders with unilateral or bilateral disc displacement(s) with reduction and pain in the area of temporomandibular joint. Patients were recruited from the Consulting Room of Temporomandibular Joint Dysfunction at the Jagiellonian University in Krakow during the years 2014-2016. In the control group the investigators used the biostymulation laser (Terapus 2, Accuro, Poland), wave length 808 nm, power 32 J in the form of 12 session (duration of a single session was 3 min 45 s), performed every second day, on the area of the both temporomandibular joints (distance to the skin was 1 cm) with opened mouth and systematic performing of muscles self-exercises with a dominant protrusive position of mandible.

No interventions assigned to this group

Interventions

Repositioning splint

Application of repositioning splint in the study group.

Intervention Type: DEVICE

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jagiellonian University

OTHER

Sponsor Role: lead

Responsible Party

Malgorzata Pihut

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Malgorzata Pihut, DDS, PhD

Role: STUDY_DIRECTOR

Jagiellonian University

Malgorzata Gorecka, DDS

Role: PRINCIPAL_INVESTIGATOR

Jagiellonian University

Piotr Ceranowicz, MD, PhD

Role: STUDY_CHAIR

Jagiellonian University

Mieszko Wieckiewicz, DMD, PhD

Role: STUDY_CHAIR

Wroclaw Medical University

References

Pihut M, Gorecka M, Ceranowicz P, Wieckiewicz M. The Efficiency of Anterior Repositioning Splints in the Management of Pain Related to Temporomandibular Joint Disc Displacement with Reduction. Pain Res Manag. 2018 Feb 21;2018:9089286. doi: 10.1155/2018/9089286. eCollection 2018.

Reference Type: DERIVED

PMID: 29682131 (View on PubMed)

Other Identifiers

122.6120.43.2016 BC

Identifier Type: -

Identifier Source: org_study_id