Temporomandibular Joint Syndrome
Conditions
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.
Interventions
DEVICE3D Analysis Group
Dental Compass and Dental Compass software used for therapeutic splint fabrication
OTHERManual Analysis Cohort
Manual methods used for therapeutic splint fabrication
Sponsors
Dr. Dean Reeves Clinic
Lourens A. Du Preez
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Cohort comparison study
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Number of splint modifications | 3-6 months | Number of splint modifications obtained from initial evaluation to confirmation of final therapeutic splint provision |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
CONTACTKenneth D Reeves, MD
CONTACTLourens A duPreez, MDT, HDDT
PRINCIPAL_INVESTIGATORKenneth D Reeves, MD
K. Dean Reeves, M.D., P.A.
Outcome results
None listed