About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
3D Analysis Group
DeviceDental Compass and Dental Compass software used for therapeutic splint fabrication
Manual Analysis Cohort
Other interventionManual methods used for therapeutic splint fabrication
Treatment groups
Trial outcomes
Primary outcomes
Number of clinic visits
Number of clinic visits from initial evaluation to confirmation of final therapeutic splint provision
Number of cone beam CTs (CBCTs)
Number of CBCTs obtained from initial evaluation to confirmation of final therapeutic splint provision
Number of splint modifications
Number of splint modifications obtained from initial evaluation to confirmation of final therapeutic splint provision
Secondary outcomes
Gelb 4/7 position achieved during treatment (3D group only)
Yes or no for Gelb 4/7 position
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
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
Improvement in total airway volume
Change in total airway volume from use of TMJ splint
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Dr. Dean Reeves Clinic
Lead sponsor
Lourens A. Du Preez
Collaborator