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Influence of Stabilization Splint Thickness on The Temporomandibular Disorders

Primary Purpose

Temporomandibular Disorder, Temporomandibular Joint Disorders, Orofacial Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
stabilization splint
Sponsored by
Istanbul Medipol University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Disorder focused on measuring stabilization splint, temporomandibular disorders, RDC/TMD, temporomandibular joint, orofacial pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    2 mm-thick splint group (2 mm-TSG)

    4 mm-thick splint group (4 mm-TSG)

    Arm Description

    The group which applied the 2 mm thick stabilization splint

    The group which applied the 4 mm thick stabilization splint

    Outcomes

    Primary Outcome Measures

    Presence of myofascial pain
    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
    Presence of intra-capsular temporomandibular disorders
    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 Outcome Measures

    Presence of TMJ sounds
    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.
    Limitation of jaw movements
    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.

    Full Information

    First Posted
    August 16, 2020
    Last Updated
    August 20, 2020
    Sponsor
    Istanbul Medipol University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04524806
    Brief Title
    Influence of Stabilization Splint Thickness on The Temporomandibular Disorders
    Official Title
    Influence of Stabilization Splint Thickness on The Temporomandibular Disorders
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    July 1, 2013 (Actual)
    Primary Completion Date
    January 1, 2014 (Actual)
    Study Completion Date
    January 30, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Istanbul Medipol University Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Temporomandibular Disorder, Temporomandibular Joint Disorders, Orofacial Pain
    Keywords
    stabilization splint, temporomandibular disorders, RDC/TMD, temporomandibular joint, orofacial pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    104 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    2 mm-thick splint group (2 mm-TSG)
    Arm Type
    Active Comparator
    Arm Description
    The group which applied the 2 mm thick stabilization splint
    Arm Title
    4 mm-thick splint group (4 mm-TSG)
    Arm Type
    Active Comparator
    Arm Description
    The group which applied the 4 mm thick stabilization splint
    Intervention Type
    Other
    Intervention Name(s)
    stabilization splint
    Intervention Description
    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 Outcome Measure Information:
    Title
    Presence of myofascial pain
    Description
    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
    Time Frame
    Up to 6 months
    Title
    Presence of intra-capsular temporomandibular disorders
    Description
    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
    Time Frame
    Up to 6 months
    Secondary Outcome Measure Information:
    Title
    Presence of TMJ sounds
    Description
    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.
    Time Frame
    Up to 6 months
    Title
    Limitation of jaw movements
    Description
    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.
    Time Frame
    Up to 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Halenur Bilir, DDS
    Organizational Affiliation
    Medipol University
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Hanefi Kurt, PhD
    Organizational Affiliation
    Medipol University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Influence of Stabilization Splint Thickness on The Temporomandibular Disorders

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