Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06619574
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-27
Brief Title:
Temporomandibular Joint TMJ Positioning Accuracy and Efficiency Using a Dental Compass
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Improving TMJ Joint Positioning and Accuracy With Therapeutic Splint Fabrication Using a Dental Compass While Reducing Radiation Exposure A Cohort Comparison
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 impression15 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None