Dental Compass for Temporomandibular Joint Disorder

Recruiting at 1 trial location

Overseen By Kenneth D Reeves, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dr. Dean Reeves Clinic

Disqualifiers: Life threatening illness, major surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 3-6 months

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new tool, the Dental Compass, to determine its effectiveness in creating mouth splints for individuals with temporomandibular joint disorder (TMD), a condition causing jaw pain and dysfunction. The study compares this method to traditional treatments, examining factors such as the number of doctor visits and adjustments needed for the splints. Suitable participants experience ongoing jaw pain and have specific jaw joint issues identified through imaging. The trial aims to discover a better, potentially more convenient way to manage TMD.

As an unphased trial, it offers patients the chance to contribute to innovative research that could lead to more convenient TMD management solutions.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Dental Compass is safe for use in TMD treatment?

Research has shown that the Dental Compass, a tool for creating therapeutic splints for jaw joint problems (TMD), is still undergoing testing for safety and effectiveness. The trial remains in an early stage, so detailed safety information from human studies may not yet be available.

While some initial safety checks might have been conducted, complete safety data from larger groups is not yet accessible. The Dental Compass might be safe, but unknown side effects could still exist.

Prospective participants should consider both the potential benefits and unknown risks. Consulting with a healthcare provider is crucial to fully understand what participation in the trial might involve. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Dental Compass for Temporomandibular Joint Disorder (TMJ) because it offers a cutting-edge approach using 3D analysis to pinpoint jaw issues. Unlike traditional methods that rely on manual examinations and adjustments, the Dental Compass provides a precise, digital assessment of jaw alignment and movement. This technology aims to enhance diagnosis accuracy and tailor treatments more effectively, which could lead to better outcomes for patients with TMJ disorder.

What evidence suggests that the Dental Compass is effective for TMD?

Research has shown that the Dental Compass, which participants in this trial may use, might help create effective mouth guards for managing Temporomandibular Joint Disorder (TMD). Early results suggest that this tool positions the jaw correctly, which is crucial for treating TMD. By using advanced software, the Dental Compass aims to create custom-fitted mouth guards that require fewer adjustments over time. This approach could potentially reduce the number of visits and changes needed compared to traditional treatments. Although more information is needed, early signs are promising for improving TMD care. ^{1 2 3 4 6}

Who Is on the Research Team?

Kenneth D Reeves, MD

Principal Investigator

K. Dean Reeves, M.D., P.A.

Are You a Good Fit for This Trial?

This trial is for individuals with TMJ dysfunction and pain, specifically those whose CBCT scans show a non-Gelb 4/7 position or less than 1.8 mm space between certain jawbone parts. It's not suitable for people who don't meet these specific scan criteria.

Inclusion Criteria

I have jaw joint pain and dysfunction.

My jaw scan shows abnormal positioning or spacing.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive therapeutic splints for TMD using the Dental Compass Articular and its software, with multiple clinic visits and CBCTs for adjustments

3-6 months

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including airway volume and joint space improvements

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dental Compass

Trial Overview The study tests if the Dental Compass Articular and its software can accurately create therapeutic splints for TMD compared to traditional methods, looking at treatment efficiency like number of visits and adjustments needed.

How Is the Trial Designed?

Group I: 3D Analysis Group Experimental Treatment 1 Intervention

Compass Use

Group II: Manual Analysis Cohort Active Control 1 Intervention

Manual Use only

Who Is Running the Clinical Trial?

Dr. Dean Reeves Clinic

Lead Sponsor

Trials

5

Recruited

220+

Lourens A. Du Preez

Collaborator

Trials

1

Recruited

80+

Published Research Related to This Trial

This systematic review analyzed 30 systematic reviews on temporomandibular disorders (TMD) and found that occlusal appliances, acupuncture, behavioral therapy, jaw exercises, and some pharmacological treatments can effectively alleviate TMD pain.

However, the evidence for the effectiveness of electrophysical modalities and surgery is insufficient, and occlusal adjustment appears to have no effect, highlighting the variability in methodologies across studies that limits definitive conclusions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of TMD: evidence from systematic reviews and meta-analyses. List, T., Axelsson, S.[2019]

A combined treatment using a hard acrylic stabilization appliance and a soft appliance significantly improved TMD symptoms in 98 patients who had previously not responded to other treatments, as indicated by a decrease in both clinical and anamnestic dysfunction indices.

While the results showed promising improvements, the study lacked a control group, highlighting the need for further randomized controlled trials to confirm the efficacy of this combined treatment approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of temporomandibular disorders with a combination of hard acrylic stabilisation appliance and a soft appliance in the opposing jaw. A retro- and prospective study. Lindfors, E., Nilsson, H., Helkimo, M., et al.[2019]

In a study of 24 adults with severe chronic pain from temporomandibular joint (TMJ) disorder, 71% consistently chewed on the same side, indicating a potential link between chewing habits and TMJ dysfunction.

The study introduced a new paradigm for understanding TMD, suggesting that the affected side may correlate with habitual chewing, flatter lateral jaw motion, or increased condylar path angles, which could enhance diagnosis and treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Jaw biodynamic data for 24 patients with chronic unilateral temporomandibular disorder. López-Cedrún, J., Santana-Mora, U., Pombo, M., et al.[2018]

The Articular Compass cephalometric analysis is effective for early diagnosis and treatment planning in patients with long face syndrome and skeletal open bite, showing a 95% confidence rate in predicting treatment success.

Children as young as six with specific measurements (gonial angle ≥ 135 degrees and Nasion-Gonion-Menton ≥ 76 degrees) are at higher risk for severe progressive issues, indicating a need for careful monitoring and potential surgical intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Articular compass: the location of frontal accessories of bioelastic appliances. Simões, WA.[2019]

The study evaluated the accuracy of different methods for determining the axial point of the temporomandibular joint (TMJ) using a teleradiographic cephalostat, comparing them to the true hinge axis.

It was found that minimizing occlusal errors in prosthetic and restorative work can be achieved by using the thinnest possible centric tracing, which helps in achieving better alignment and function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Comparative studies on the axial point of the prosthesis]. Bratschko, R., Cartellieri, W., Leopold, S., et al.[2016]

Axiography is a useful tool for studying temporomandibular joint (TMJ) dysfunctions, providing valuable insights into condylar paths and aiding in the interpretation of joint movement.

In a case study of a patient with unilateral closed lock TMJ dysfunction due to dental malposition, axiography complemented clinical and radiographic assessments, enhancing the overall diagnostic process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Axiography in diagnosis and treatment of TMJ dysfunction]. Schiavoni, R., Grenga, V.[2006]

In a study of 111 patients, arthrocentesis combined with joint washing and hyaluronic acid injection significantly reduced pain and improved oral opening at 1 week, 1 month, and 3 months after the procedure, although these benefits diminished by 6 months.

The effectiveness of arthrocentesis is influenced by the type of joint pathology, with patients suffering from degenerative conditions experiencing a decline in benefits after 6 months, suggesting that early intervention may be crucial for acute joint issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective study to evaluate the influence of joint washing and the use of hyaluronic acid on 111 arthrocentesis. Gavin Clavero, MA., Simón Sanz, MV., Mur Til, A., et al.[2022]

In healthy individuals, the movement of the condylar kinematic center during jaw opening closely follows the contour of the articular eminence, indicating a normal relationship between these structures.

In TMD patients, irregular condylar movement patterns were observed, particularly in those with disk displacement, suggesting that the kinematic center could be a useful reference for assessing joint function and dysfunction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A study on relationship between the contour of articular eminence and traces of the condylar kinematic center and its application in TMD patients]. Hou, ZG., Feng, HL., Zheng, ZZ., et al.[2006]

In a study of 65 myofascial Temporomandibular disorder (TMD) patients, treatment with oral appliances led to significant improvements in pain intensity and other related symptoms over a 1-year follow-up, regardless of whether patients had localized or widespread pain.

The results suggest that oral appliances are effective for managing TMD pain, and pain-site drawings can aid clinicians in treatment planning, although patients with widespread pain may face additional challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Similar treatment outcome in myofascial TMD patients with localized and widespread pain. Doepel, M., Nilner, M., Vahlberg, T., et al.[2018]

Citations

1. trials.arthritis.org trials.arthritis.org/trials/NCT06619574

Temporomandibular Joint (TMJ) Positioning Accuracy and ... 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 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06619574?cond=dental&locStr=United+States&country=United+States&aggFilters=status:

Temporomandibular Joint (TMJ) Positioning Accuracy and ... A structured online system, such as the ClinicalTrials.gov results database, that provides the public with access to registration and summary results ...

3. withpower.com withpower.com/clinical-trials/for-temporomandibular-joint

Top Temporomandibular Joint Clinical Trials | Power 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 ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/condition/272/oral-facial-pain

Oral Facial Pain Clinical Research Trials Temporomandibular Joint (TMJ) Positioning Accuracy and Efficiency Using a Dental Compass. Standard practice in the treatment of temporomandibular dysfunction ...

5. clinconnect.io clinconnect.io/trials/NCT06619574

Temporomandibular Joint (TMJ) Positioning Accuracy and 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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8631581/

Temporomandibular disorders: a review of current concepts in ... TMJ 'clicking' was reported by 30% of adults, while only 8% were diagnosed with a disc displacement (DD). The estimated prevalence of TMD degenerative joint ...