Temporomandibular Joint (TMJ) Positioning Accuracy and Efficiency Using a Dental Compass.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 3D Analysis Group, Manual Analysis Cohort.
- Who it may be relevant to
- Registry conditions: Temporomandibular Joint Syndrome. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Improving TMJ Joint Positioning and Accuracy With Therapeutic Splint Fabrication Using a Dental Compass While Reducing Radiation Exposure: A Cohort Comparison
Overview
This study is being performed to determine if the use of the Dental Compass Articular and its software will produce therapeutic splints for TMD accurately and successfully, compare favorably with a cohort treated without the Dental Compass (for number of visits, splint modifications, and required CBCTs).
Detailed description
Standard practice in the treatment of temporomandibular dysfunction (TMD) currently involves non-radiographically-assisted manual repositioning of the jaw followed by either an in-office cone beam computerized tomography (CBCT) or tomographic X-ray of both TMJs, and further adjustment as necessary to improve the initial bite impression.\[15\] At follow up visits the therapeutic splint is modified in stages to "walk" the condyle progressively into the ideal position, such as altering side shift, lateral deviation, and rotation. During this process multiple CBCTs or tomographic X-rays, and multiple direct dentist interventions, are required to find the precise joint position, involving significant radiation exposure, and significant chair time for the dentist
The key advantage of using the Dental Compass Articulator in conjunction with its software, is to identify and suggest corrections for the range of orthopedic imbalances present. Software-facilitated identification of imbalances is coupled with manipulation of yaw (anterior, posterior, lateral, or rotational movement of the mandible in a horizontal plane), pitch (rotation of the mandible in a frontal vertical plane), and roll (rotation of the mandible in a lateral vertical plane) to achieve optimal condylar and mandibular position for splint manufacture.
The goals of this study are to:
1. Determine if the use of the Dental Compass Articular and its software will produce therapeutic splints for TMD accurately and successfully, and will compare favorably with a cohort treated without the Dental Compass (for number of visits, splint modifications, and required CBCTs), and 2. Confirm a clinically important reduction in airway constriction and improvement in airway volume with us of the therapeutic splint.
Interventions
- Device 3D Analysis Group
Dental Compass and Dental Compass software used for therapeutic splint fabrication - Other Manual Analysis Cohort
Manual methods used for therapeutic splint fabrication
Primary outcome measures
- Number of clinic visits [Time frame: 3-6 months]
- Number of cone beam CTs (CBCTs) [Time frame: 3-6 months]
- Number of splint modifications [Time frame: 3-6 months]
Secondary outcome measures (5)
- Gelb 4/7 position achieved during treatment (3D group only) [Time frame: 3-6 months]
- Anterior joint space of 1.8 mm or more achieved during treatment (3D group only) [Time frame: 3-6 months]
- Posterior joint space of 1.8 mm or more achieved during treatment (3D group only) [Time frame: 3-6 months]
- Improvement in total airway volume [Time frame: 3-6 months]
- Improvement in minimum airway diameter [Time frame: 3-6 months]
Eligibility criteria
Inclusion Criteria for prospective active participants:
- TMJ dysfunction and pain
- CBCT indicates a non-Gelb 4/7 position or < 1.8 mm bone to bone interval between the mandibular condyle and mandibular fossa anteriorly or posteriorly.
Exclusion criteria
- Planning a move within 9 months.
- Unwilling to provide two phone numbers and two email contacts.
- Not willing to express a willingness to come in for 4-6 month follow up if they have marked improvement or improvement in symptoms.
- Not living within 90-minute drive from clinic
- Transportation not reliable
- Involved in any other TMD study
- Life threatening illness or major surgery planned
- Other major life stress that might interfere with completing the study
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Skalff Dental Studio and Technologies 103 C West Broadway Street #3736 — Gainesville
Identifiers
NCT: NCT06619574 · Dental Compass - 01