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
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
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
NCT ID
NCT04524806
First Posted
August 16, 2020
Last Updated
August 20, 2020
Sponsor
Istanbul Medipol University Hospital
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
Learn more about this trial
Influence of Stabilization Splint Thickness on The Temporomandibular Disorders
We'll reach out to this number within 24 hrs