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

NCT03057262 | Completed FDA Device

• 1 other identifier: 122.6120.43.2016 BC
• Study Type: observational
• Target: 112
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Temporomandibular Joint Disc Displacement

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

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.

Interventions

Repositioning splint DEVICE

Application of repositioning splint in the study group.

Study group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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),
• in the previous 30 days, any TMJ noise(s) present with jaw movement or function,
• unilateral or bilateral pain in the area of temporomandibular joint,
• presence of masticatory muscles contracture,
• full dentition or single tooth loss,
• good general health,
• positive mandible protrusion test,
• no contraindications for laser therapy
• patient consent to be involved in the study.

You may not qualify if:

• partial tooth loss or edentulism,
• contraindications for laser therapy
• absence of appropriate symptoms
• absence of consent to be involved in the study

Sponsors & Collaborators

• Jagiellonian University: lead

Related Publications (1)

• 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.

  PMID: 29682131 DERIVED

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Study Officials

• Malgorzata Pihut, DDS, PhD

  Jagiellonian University

  STUDY DIRECTOR

• Malgorzata Gorecka, DDS

  Jagiellonian University

  PRINCIPAL INVESTIGATOR

• Piotr Ceranowicz, MD, PhD

  Jagiellonian University

  STUDY CHAIR

• Mieszko Wieckiewicz, DMD, PhD

  Wroclaw Medical University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 15, 2017
• First Posted: February 20, 2017
• Study Start: February 1, 2014
• Primary Completion: February 1, 2014
• Study Completion: December 1, 2016
• Last Updated: March 21, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share