Trials / Recruiting
RecruitingNCT06619574
Temporomandibular Joint (TMJ) Positioning Accuracy and Efficiency Using a Dental Compass.
Improving TMJ Joint Positioning and Accuracy With Therapeutic Splint Fabrication Using a Dental Compass While Reducing Radiation Exposure: A Cohort Comparison
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- Sponsor
- Dr. Dean Reeves Clinic · Academic / Other
- Sex
- All
- Age
- 18 Years – 90 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2024-11-08
- Primary completion
- 2026-11-01
- Completion
- 2027-03-01
- First posted
- 2024-10-01
- Last updated
- 2025-02-06
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT06619574. Inclusion in this directory is not an endorsement.