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NCT Number: NCT06619574

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

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).

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Skalff Dental Studio and Technologies 103 C West Broadway Street #3736

Gainesville, Texas, 76240, United States

Location status: Recruiting

Location contact

Lourens A duPreez

CONTACT

[email protected]

940-580-9486

About this study

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:

  • 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
  • Confirm a clinically important reduction in airway constriction and improvement in airway volume with us of the therapeutic splint.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3D Analysis Group

Device

Dental Compass and Dental Compass software used for therapeutic splint fabrication

Manual Analysis Cohort

Other

Manual methods used for therapeutic splint fabrication

Primary outcomes

  1. Number of clinic visits

    Time frame: 3-6 months

    Number of clinic visits from initial evaluation to confirmation of final therapeutic splint provision

  2. Number of cone beam CTs (CBCTs)

    Time frame: 3-6 months

    Number of CBCTs obtained from initial evaluation to confirmation of final therapeutic splint provision

  3. Number of splint modifications

    Time frame: 3-6 months

    Number of splint modifications obtained from initial evaluation to confirmation of final therapeutic splint provision

Secondary outcomes

  1. Gelb 4/7 position achieved during treatment (3D group only)

    Time frame: 3-6 months

    Yes or no for Gelb 4/7 position

  2. Anterior joint space of 1.8 mm or more achieved during treatment (3D group only)

    Time frame: 3-6 months

    Yes or no for anterior joint space of 1.8 mm or more

  3. Posterior joint space of 1.8 mm or more achieved during treatment (3D group only)

    Time frame: 3-6 months

    Yes or no for posterior joint space of 1.8 mm or more

  4. Improvement in total airway volume

    Time frame: 3-6 months

    Change in total airway volume from use of TMJ splint

  5. Improvement in minimum airway diameter

    Time frame: 3-6 months

    Change in total airway volume from use of TMJ splint

Study contacts

Contact information is provided by the study sponsor or research team.

Kenneth D Reeves, MD

CONTACT

[email protected]

9139637750

Lourens A duPreez, MDT, HDDT

CONTACT

[email protected]

940-580-9486

Sponsors and collaborators

Lead sponsor

Dr. Dean Reeves Clinic

Other

Collaborators

  • Lourens A. Du Preez

Registry information

Official study title

Improving TMJ Joint Positioning and Accuracy With Therapeutic Splint Fabrication Using a Dental Compass While Reducing Radiation Exposure: A Cohort Comparison

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Oct 1, 2024
Registry last updated
Feb 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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