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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

TypeNameDescription
DEVICE3D Analysis GroupDental Compass and Dental Compass software used for therapeutic splint fabrication
OTHERManual Analysis CohortManual 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.