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Completed

NCT Number: NCT04524806

Influence of Stabilization Splint Thickness on The Temporomandibular Disorders

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

stabilization splint

Other

Stabilization splint is an appliance which applied to upper or lower jaw and regulating the occlusal forces in the temporomandibular joint that can cause disorders, also preventing excessive contraction of the masticatory muscles

Primary outcomes

  1. Presence of myofascial pain

    Time frame: Up to 6 months

    Myofascial pain and myofascial pain with limited opening are in the Group I according to the RDC/TMD.

    I.a Myofascial pain:

    • Reported pain in masticatory muscles (In the jaw, temples, face, preauricular area, or inside the ear, at rest or function)
    • Pain on palpation in at least 3 sites (There are 20 sites (ten on each side): posterior, middle and anterior Temporalis; origin, body and insertion of Masseter; posterior mandibular region; Submandibular region; lateral Pterygoid; tendon of Temporalis), one of them at least in the same side of the reported pain

    I.b Myofascial pain with limited opening:

    • Myofascial pain
    • Pain-free unassisted 3 opening< 40 mm and Passive 4 stretch ≥ 5 mm
  2. Presence of intra-capsular temporomandibular disorders

    Time frame: Up to 6 months

    II.a Disc displacement with reduction:

    • No pain in the joint
    • Reproducible (All clicks must be reproduced 2 out of 3 consecutive trials) click on excursion with either opening or closing click
    • With click on opening and closing (unless excursive click confirmed):
    • Click on opening occurs at ≥ 5 mm interincisal distance than on closing
    • Clicks eliminated by protrusive opening

    II.b Disc displacement without reduction with limited opening:

    • History of locking or catching that interfered with eating
    • Absence of TMJ clicking
    • Unassisted opening (even painful) ≤ 35mm and passive stretch ≤ 4mm
    • Contralateral excursion < 7mm

    II.c Disc displacement without reduction without limited opening:

    • History of locking or catching that interfered with eating
    • The presence of TMJ sounds excluding DDR clicking
    • Unassisted opening (even painful) > 35mm and passive stretch > 4mm
    • Contralateral excursion ≥ 7mm

Secondary outcomes

  1. Presence of TMJ sounds

    Time frame: Up to 6 months

    Click: A distinct sound, of brief and very limited duration, with a clear beginning and end, which usually sounds like a "click."

    Opening Click: If upon opening and closing from maximum intercuspation, a click is noted on two of three opening movements, record as positive for opening click.

    Closing Click: A click present on two of three closing mandibular movements.

  2. Limitation of jaw movements

    Time frame: Up to 6 months

    The researcher places the edge of the millimeter ruler at the incisal edge of the maxillary central incisor that is the most vertically oriented and measures vertically to the labioincisal edge of the opposing mandibular incisor; records this measurement.

Sponsors and collaborators

Lead sponsor

Istanbul Medipol University Hospital

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Aug 24, 2020
Registry last updated
Aug 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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