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

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).

Study Overview

• Status: Recruiting
• Conditions: Temporomandibular Joint Syndrome
• Intervention / Treatment: Device: 3D Analysis Group; Other: Manual Analysis Cohort

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 Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kenneth D Reeves, MD; Phone Number: 9139637750; Email: deanreevesMD@gmail.com
• Study Contact Backup: Name: Lourens A duPreez, MDT, HDDT; Phone Number: 940-580-9486; Email: lourensdupreez903@gmail.com

Study Locations

• United States
  • Texas
    • Gainesville, Texas, United States, 76240
      • Recruiting
      • Skalff Dental Studio and Technologies 103 C West Broadway Street #3736
      • Contact: Lourens A duPreez; Phone Number: 940-580-9486; Email: lourensdupreez903@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 3D Analysis Group; Compass Use	Device: 3D Analysis Group; Dental Compass and Dental Compass software used for therapeutic splint fabrication
Active Comparator: Manual Analysis Cohort; Manual Use only	Other: Manual Analysis Cohort; Manual methods used for therapeutic splint fabrication

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Dr. Dean Reeves Clinic
• Collaborators: Lourens A. Du Preez
• Investigators: Principal Investigator: Kenneth D Reeves, MD, K. Dean Reeves, M.D., P.A.

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: September 27, 2024
• First Submitted That Met QC Criteria: September 27, 2024
• First Posted (Actual): October 1, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 4, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Muscular Diseases; Joint Diseases; Jaw Diseases; Mandibular Diseases; Craniomandibular Disorders; Myofascial Pain Syndromes; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
• Other Study ID Numbers: Dental Compass - 01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All non identifying data
• IPD Sharing Time Frame: Indefinitely
• IPD Sharing Access Criteria: By email request to P.I. at DeanReevesMD@gmail.com
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No