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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 90 Years
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06619574
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Dr. Dean Reeves Clinic
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Kenneth D Reeves, MD
Principal Investigator Affiliation	K. Dean Reeves, M.D., P.A.
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Temporomandibular Joint Syndrome

Additional Details

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.

Arms & Interventions

Arms

Experimental: 3D Analysis Group

Compass Use

Active Comparator: Manual Analysis Cohort

Manual Use only

Interventions

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Gainesville, Texas

Status

Recruiting

Address

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

Gainesville, Texas, 76240

Site Contact

Lourens A duPreez

[email protected]

940-580-9486

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