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| Name | Class |
|---|---|
| Lourens A. Du Preez | UNKNOWN |
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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).
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3D Analysis Group | Experimental | Compass Use |
|
| Manual Analysis Cohort | Active Comparator | Manual Use only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3D Analysis Group | Device | Dental Compass and Dental Compass software used for therapeutic splint fabrication |
|
| 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 |
| 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 |
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Inclusion Criteria for prospective active participants:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kenneth D Reeves, MD | Contact | 9139637750 | deanreevesMD@gmail.com | |
| Lourens A duPreez, MDT, HDDT | Contact | 940-580-9486 | lourensdupreez903@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Kenneth D Reeves, MD | K. Dean Reeves, M.D., P.A. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skalff Dental Studio and Technologies 103 C West Broadway Street #3736 | Recruiting | Gainesville | Texas | 76240 | United States |
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By email request to P.I. at DeanReevesMD@gmail.com
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| ID | Term |
|---|---|
| D013706 | Temporomandibular Joint Dysfunction Syndrome |
| ID | Term |
|---|---|
| D013705 | Temporomandibular Joint Disorders |
| D017271 | Craniomandibular Disorders |
| D008336 | Mandibular Diseases |
| D007571 | Jaw Diseases |
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Cohort comparison study
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| Manual Analysis Cohort | Other | Manual methods used for therapeutic splint fabrication |
|
| 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 |
| D009140 | Musculoskeletal Diseases |
| D007592 | Joint Diseases |
| D009135 | Muscular Diseases |
| D009209 | Myofascial Pain Syndromes |
| D009057 | Stomatognathic Diseases |