Clinical trial NCT03057262: The Efficiency of Anterior Repositioning Splint for the Management of Temporomandibular Joint Dysunction
Official title: The Efficiency of Anterior Repositioning Splint for the Management of Pain Related to Temporomandibular Joint Disc Displacement With Reduction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Temporomandibular Joint Disc Displacement
Keywords: temporomandibular joint disorders
disc displacement with reduction
anterior repositioning splint
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2017-02-20
Enrollment: 112
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).

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

Primary outcomes:
measure: Pain relief related to temporomandibular joint disc displacement with reduction
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Jagiellonian University
name: Malgorzata Pihut, DDS, PhD
role: STUDY_DIRECTOR
affiliation: Jagiellonian University
name: Malgorzata Gorecka, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Jagiellonian University
name: Piotr Ceranowicz, MD, PhD
role: STUDY_CHAIR
affiliation: Wroclaw Medical University
name: Mieszko Wieckiewicz, DMD, PhD
role: STUDY_CHAIR
References:
citation: 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.