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Influence of Stabilization Splint Thickness on The Temporomandibular Disorders

M

Medipol Health Group

Status

Completed

Conditions

Temporomandibular Joint Disorders
Orofacial Pain
Temporomandibular Disorder

Treatments

Other: stabilization splint

Study type

Interventional

Funder types

Other

Identifiers

NCT04524806
halenurbilir

Details and patient eligibility

About

The aim of the study is assessing the effect of the stabilization splint (SS) thickness on the temporomandibular disorder's and their symptoms; such as muscle or temporomandibular joint (TMJ) pain, TMJ sounds, and limitation of mouth opening.

Full description

Participants are selected from patients who applied to the clinic with the complaint of temporomandibular disorders (TMDs). Symptoms are evaluated with RDC/TMD forms. Regarding the treatment plan, patients are divided into two groups; 2 mm-thick splint group (2 mm-TSG) and 4 mm-thick splint group (4 mm-TSG). They used SS's at night for 8 hours, and they were recalled on 1st, 2nd, 3rd, and 6th months after splint insertion. Their symptoms and splints are checked.

Enrollment

104 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • No need for orthodontic treatment
  • Maximum 2 teeth have been extracted
  • Having efficient occlusal contacts
  • Patients in the axis 1 and axis 2 groups according to Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD)

Exclusion criteria

  • Treated with stabilization splint before
  • Partial edentulous patients
  • Patients in the axis 3 group according to Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

104 participants in 2 patient groups

2 mm-thick splint group (2 mm-TSG)
Active Comparator group
Description:
The group which applied the 2 mm thick stabilization splint
Treatment:
Other: stabilization splint
4 mm-thick splint group (4 mm-TSG)
Active Comparator group
Description:
The group which applied the 4 mm thick stabilization splint
Treatment:
Other: stabilization splint

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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