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

• ClinicalTrials.gov Identifier: NCT03057262
• Recruitment Status: Completed
• First Posted: February 20, 2017
• Last Update Posted: March 21, 2017
• Sponsor: Jagiellonian University
• Information provided by (Responsible Party): Malgorzata Pihut, Jagiellonian University

Study Description

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.

Condition or disease	Intervention/treatment
Temporomandibular Joint Disc Displacement	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 Design

• Study Type: Observational
• Actual Enrollment: 112 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: The Efficiency of Anterior Repositioning Splint for the Management of Pain Related to Temporomandibular Joint Disc Displacement With Reduction
• Actual Study Start Date: February 2014
• Actual Primary Completion Date: February 2014
• Actual Study Completion Date: December 2016

Groups and Cohorts

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.

Outcome Measures

Primary Outcome Measures :

1. Pain relief related to temporomandibular joint disc displacement with reduction [ Time Frame: 16 weeks ]
   Repositioning splint was applied to check its efficiency of pain relieving in a case of temporomandibular joint disc displacement with reduction.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

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

Contacts and Locations

Sponsors and Collaborators

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
• Study Chair: Mieszko Wieckiewicz, DMD, PhD; Wroclaw Medical University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Malgorzata Pihut, Associate Professor, Jagiellonian University
• ClinicalTrials.gov Identifier: NCT03057262
• Other Study ID Numbers: 122.6120.43.2016 BC
• First Posted: February 20, 2017
• Last Update Posted: March 21, 2017
• Last Verified: March 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by Malgorzata Pihut, Jagiellonian University:

temporomandibular joint disorders; disc displacement with reduction; anterior repositioning splint