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

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.

Study Overview

• Status: Completed
• Conditions: Temporomandibular Joint Disc Displacement
• Intervention / Treatment: Device: Repositioning splint

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).

• Study Type: Observational
• Enrollment (Actual): 112

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

A total of 112 subjects were included to the study, 83 women and 29 men aged 24-45 years (mean age was 31). The study group includes 40 women and 16 men, and the control group contains 43 women and 13 men.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: Repositioning splint; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Jagiellonian University
• Investigators: Study Director: Malgorzata Pihut, DDS, PhD, Jagiellonian University; Principal Investigator: Malgorzata Gorecka, DDS, Jagiellonian University; Study Chair: Piotr Ceranowicz, MD, PhD, Jagiellonian University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2014
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: February 15, 2017
• First Submitted That Met QC Criteria: February 17, 2017
• First Posted (Actual): February 20, 2017

Study Record Updates

• Last Update Posted (Actual): March 21, 2017
• Last Update Submitted That Met QC Criteria: March 19, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: temporomandibular joint disorders; disc displacement with reduction; anterior repositioning splint
• Other Study ID Numbers: 122.6120.43.2016 BC

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: Yes
• product manufactured in and exported from the U.S.: No