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

Not Applicable

Recruiting

• Conditions: Temporomandibular Joint Syndrome

• Registration Number: NCT06619574
• Lead Sponsor: Dr. Dean Reeves Clinic

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.

Study Timeline

• Study First Submitted: 2024-09-27
• Study First Submitted QC: 2024-09-27
• Study First Posted: 2024-10-01
• Study Start: 2024-11-08
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-06
• Primary Completion: 2026-11-01
• Study Completion: 2027-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of splint modifications	3-6 months	Number of splint modifications obtained from initial evaluation to confirmation of final therapeutic splint provision
Number of clinic visits	3-6 months	Number of clinic visits from initial evaluation to confirmation of final therapeutic splint provision
Number of cone beam CTs (CBCTs)	3-6 months	Number of CBCTs obtained from initial evaluation to confirmation of final therapeutic splint provision

Secondary Outcome Measures

Name	Time	Method
Gelb 4/7 position achieved during treatment (3D group only)	3-6 months	Yes or no for Gelb 4/7 position
Anterior joint space of 1.8 mm or more achieved during treatment (3D group only)	3-6 months	Yes or no for anterior joint space of 1.8 mm or more
Posterior joint space of 1.8 mm or more achieved during treatment (3D group only)	3-6 months	Yes or no for posterior joint space of 1.8 mm or more
Improvement in total airway volume	3-6 months	Change in total airway volume from use of TMJ splint
Improvement in minimum airway diameter	3-6 months	Change in total airway volume from use of TMJ splint

Trial Locations

Locations (1)

Skalff Dental Studio and Technologies 103 C West Broadway Street #3736; 🇺🇸 Gainesville, Texas, United States