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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorDr. Dean Reeves Clinic

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • 3D Analysis Group

    Device

    Dental Compass and Dental Compass software used for therapeutic splint fabrication

  • Manual Analysis Cohort

    Other intervention

    Manual methods used for therapeutic splint fabrication

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: 3D Analysis GroupExperimental treatment 1 intervention
Group B: Manual Analysis CohortActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of clinic visits

Number of clinic visits from initial evaluation to confirmation of final therapeutic splint provision

Time frame
3-6 months
2

Number of cone beam CTs (CBCTs)

Number of CBCTs obtained from initial evaluation to confirmation of final therapeutic splint provision

Time frame
3-6 months
3

Number of splint modifications

Number of splint modifications obtained from initial evaluation to confirmation of final therapeutic splint provision

Time frame
3-6 months

Secondary outcomes

1

Gelb 4/7 position achieved during treatment (3D group only)

Yes or no for Gelb 4/7 position

Time frame
3-6 months
2

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

Time frame
3-6 months
3

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

Time frame
3-6 months
4

Improvement in total airway volume

Change in total airway volume from use of TMJ splint

Time frame
3-6 months

Other outcomes

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