Temporomandibular Joint SyndromeNCT06619574
Temporomandibular Joint (TMJ) Positioning Accuracy and Efficiency Using a Dental Compass.
A study testing 3D Analysis Group and Manual Analysis Cohort in people with Temporomandibular Joint Syndrome, run by Dr. Dean Reeves Clinic at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Temporomandibular Joint Syndrome
- What is being tested?
- 3D Analysis Group and Manual Analysis Cohort
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2024to 1 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Skalff Dental Studio and Technologies 103 C West Broadway Street #3736
Gainesville, Texas, 76240
Lourens A duPreez, 940-580-9486, lourensdupreez903@gmail.com
About this study
Official title: Improving TMJ Joint Positioning and Accuracy With Therapeutic Splint Fabrication Using a Dental Compass While Reducing Radiation Exposure: A Cohort Comparison
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).
Read the 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:
- 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
- Confirm a clinically important reduction in airway constriction and improvement in airway volume with us of the therapeutic splint.
- Conditions
- Temporomandibular Joint Syndrome
- Being tested
- 3D Analysis Group, Manual Analysis Cohort
- Medical subject headings
- Temporomandibular Joint Dysfunction Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D Analysis GroupDevice
Dental Compass and Dental Compass software used for therapeutic splint fabrication
Manual Analysis CohortOther
Manual methods used for therapeutic splint fabrication
| Study group | Role | What they receive |
|---|---|---|
| 3D Analysis Group | Experimental | Compass Use Receives: Device: 3D Analysis Group |
| Manual Analysis Cohort | Active comparator | Manual Use only Receives: Other: Manual Analysis Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of clinic visits
Number of clinic visits from initial evaluation to confirmation of final therapeutic splint provision
Measured: 3-6 months
Number of cone beam CTs (CBCTs)
Number of CBCTs obtained from initial evaluation to confirmation of final therapeutic splint provision
Measured: 3-6 months
Number of splint modifications
Number of splint modifications obtained from initial evaluation to confirmation of final therapeutic splint provision
Measured: 3-6 months
Secondary outcomes (5)
Gelb 4/7 position achieved during treatment (3D group only)
Yes or no for Gelb 4/7 position
Measured: 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
Measured: 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
Measured: 3-6 months
Improvement in total airway volume
Change in total airway volume from use of TMJ splint
Measured: 3-6 months
Improvement in minimum airway diameter
Change in total airway volume from use of TMJ splint
Measured: 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start8 Nov 2024
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Joint SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Cohort comparison study
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Dean Reeves Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Lourens A. Du Preez
- Responsible party
- Principal investigator, Dr. Dean Reeves, Dr. Dean Reeves Clinic
- Investigators
- Kenneth D Reeves, MD, Principal investigator, K. Dean Reeves, M.D., P.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06619574
- Sponsor's protocol ID
- Dental Compass - 01
- Status last verified
- Aug 2026
- First submitted
- 27 Sep 2024
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All non identifying data
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving TMJ Joint Positioning and Accuracy With Therapeutic Splint Fabrication Using a Dental Compass While Reducing Radiation Exposure: A Cohort Comparison
- ClinicalTrials.gov ID
- NCT06619574
- Acronym / sponsor ID
- Dental Compass - 01
- Conditions
- Temporomandibular Joint Syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Dr. Dean Reeves ClinicUniversity, hospital or other
- Collaborators
- Lourens A. Du Preez
- Study start
- 8 Nov 2024 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- Confirm a clinically important reduction in airway constriction and improvement in airway volume with us of the therapeutic splint.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cohort comparison study
| Arm | Type | Receives |
|---|---|---|
| 3D Analysis Group | Experimental | Device: 3D Analysis GroupCompass Use |
| Manual Analysis Cohort | Active comparator | Other: Manual Analysis CohortManual Use only |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D Analysis GroupDental Compass and Dental Compass software used for therapeutic splint fabrication | Device | 3D Analysis Group |
| Manual Analysis CohortManual methods used for therapeutic splint fabrication | Other | Manual Analysis Cohort |
Primary outcome
Number of clinic visits
Time frame: 3-6 months
Number of clinic visits from initial evaluation to confirmation of final therapeutic splint provision
Number of cone beam CTs (CBCTs)
Time frame: 3-6 months
Number of CBCTs obtained from initial evaluation to confirmation of final therapeutic splint provision
Number of splint modifications
Time frame: 3-6 months
Number of splint modifications obtained from initial evaluation to confirmation of final therapeutic splint provision
5 secondary outcomes
Gelb 4/7 position achieved during treatment (3D group only)
Time frame: 3-6 months
Anterior joint space of 1.8 mm or more achieved during treatment (3D group only)
Time frame: 3-6 months
Posterior joint space of 1.8 mm or more achieved during treatment (3D group only)
Time frame: 3-6 months
Improvement in total airway volume
Time frame: 3-6 months
Improvement in minimum airway diameter
Time frame: 3-6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: Yes. All non identifying data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kenneth D Reeves, MD principal investigator
K. Dean Reeves, M.D., P.A.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D Analysis Group and Manual Analysis Cohort in people with Temporomandibular Joint Syndrome, run by Dr. Dean Reeves Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kenneth D Reeves, MD (9139637750, deanreevesMD@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of clinic visits (time frame: 3-6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.