Clinical trial NCT06619574: Temporomandibular Joint (TMJ) Positioning Accuracy and Efficiency Using a Dental Compass.
Official title: Improving TMJ Joint Positioning and Accuracy With Therapeutic Splint Fabrication Using a Dental Compass While Reducing Radiation Exposure: A Cohort Comparison
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Temporomandibular Joint Syndrome
Lead sponsor: Dr. Dean Reeves Clinic
Sponsor class: OTHER
Collaborators: name: Lourens A. Du Preez
First posted: 2024-10-01
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Cohort comparison study
Primary purpose: TREATMENT

Brief summary: 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.

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

Primary outcomes:
measure: Number of clinic visits
timeFrame: 3-6 months
measure: Number of cone beam CTs (CBCTs)
timeFrame: 3-6 months
measure: Number of splint modifications
timeFrame: 3-6 months
Secondary outcomes:
measure: Gelb 4/7 position achieved during treatment (3D group only)
timeFrame: 3-6 months
measure: Anterior joint space of 1.8 mm or more achieved during treatment (3D group only)
timeFrame: 3-6 months
measure: Posterior joint space of 1.8 mm or more achieved during treatment (3D group only)
timeFrame: 3-6 months
measure: Improvement in total airway volume
timeFrame: 3-6 months
measure: Improvement in minimum airway diameter
timeFrame: 3-6 months
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Skalff Dental Studio and Technologies 103 C West Broadway Street #3736
state: Texas
Study officials:
affiliation: K. Dean Reeves, M.D., P.A.
name: Kenneth D Reeves, MD
role: PRINCIPAL_INVESTIGATOR
References: