Temporomandibular Joint (TMJ) Positioning Accuracy and Efficiency Using a Dental Compass.

Dr. Dean Reeves Clinic

Status: Enrolling

Conditions: Temporomandibular Joint Syndrome

Treatments: Device: 3D Analysis Group; Other: Manual Analysis Cohort

Study type: Interventional

Funder types: Other

Identifiers

NCT06619574

Dental Compass - 01

Details and patient eligibility

About

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).

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

3D Analysis Group

Experimental group

Description:

Compass Use

Treatment:

Device: 3D Analysis Group

Manual Analysis Cohort

Active Comparator group

Description:

Manual Use only

Treatment:

Other: Manual Analysis Cohort