Individualized Treatment for TMJ Dysfunction

(TMD3c Trial)

Overseen By Elise Kabela-Cormier, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: UConn Health

Must not be taking: Narcotic pain medication

Disqualifiers: Psychosis, Neuropathic pain, Pregnancy, others

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

Compensation: Varies

Number of Visits: 7

Duration: 6 weeks

160 Participants Needed

Trial Summary

What is the purpose of this trial?

Temporomandibular/orofacial pain disorders (TMD) are a group of painful conditions with multiple determinants.This proposal has two main goals: 1) to test a highly individualized, adaptive treatment for TMD that has potential to be more effective than other psychosocial treatments; and 2) to discover the mechanisms by which psychosocial treatments work in chronic pain. TMD patients (N=160) will be randomized to receive standard care (STD) + an individualized assessment and treatment program (IATP) or to standard care + conventional cognitive-behavioral treatment (STD+CBT). It is expected that the STD+IATP treatment will yield lower pain, depression and interference scores over time than STD+CBT, and that changes in coping ability will mediate the treatment effects on outcomes.

Will I have to stop taking my current medications?

The trial requires that you do not take narcotic pain medication. If you are currently taking narcotics for pain, you would need to stop before participating.

What data supports the effectiveness of the treatment for TMJ dysfunction?

Research shows that treatments for temporomandibular disorders (TMD), which include TMJ dysfunction, can lead to significant improvement. In one study, 88% of patients reported a 50% or more improvement in their symptoms, indicating that individualized treatment approaches can be effective. ^{1 2 3 4 5}

Is the treatment for TMJ dysfunction generally safe for humans?

The research reviewed does not provide specific safety data for the treatment of TMJ dysfunction, but it highlights the need for better reporting of adverse events (harms) in clinical trials for temporomandibular disorders (TMDs). ^{1 6 7 8 9}

How is the Individualized Assessment and Treatment Program (IATP) for TMJ dysfunction different from other treatments?

The Individualized Assessment and Treatment Program (IATP) for TMJ dysfunction is unique because it tailors the treatment to each patient's specific needs, unlike standard treatments that often follow a one-size-fits-all approach. This personalized method may involve a combination of physical therapy, rehabilitation, and other interventions based on the individual's condition, potentially leading to better outcomes. ^{4 7 10 11 12}

Research Team

Mark D Litt, Ph.D.

Principal Investigator

UConn Health

Eligibility Criteria

This trial is for adults over 18 living in the Greater Hartford, CT area with facial pain or TMJ disorders. Participants must have a confirmed diagnosis of TMD and experience jaw pain for more than three months. It's not open to those on narcotic pain meds, with previous TMD surgery, severe TM joint damage, non-English speakers, neuropathic/odontogenic pain origins, certain comorbid conditions or current depression treatment.

Inclusion Criteria

I have been diagnosed with a muscle or fascia condition.

I have been diagnosed with muscle pain, joint pain, or TMJ-related headaches.

You live in the Greater Hartford. CT area

Exclusion Criteria

I have been diagnosed with nerve or tooth-related pain.

You have been diagnosed with a mental illness called psychosis.

I use a device in my mouth for a health condition like sleep apnea.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-treatment Monitoring

Experience Sampling (ES) procedure conducted via smartphone app to gather information on patients' pain, momentary cognitions, affects, and coping behaviors

2 weeks

Remote monitoring

Treatment

Participants receive either STD+IATP or STD+CBT treatment, including 6 sessions of cognitive-behavioral coping skills training

6 weeks

Follow-up

Participants are monitored for changes in depressive symptoms, pain, interference, and coping ability at multiple follow-up points

12 months

Follow-up assessments at 7 weeks, 3 months, 6 months, 9 months, and 12 months

Treatment Details

Interventions

• Cognitive-Behavioral Treatment
• Individualized Assessment and Treatment Program
• Standard Conservative Care

Trial Overview The study compares two treatments for TMD: an individualized assessment and treatment program (IATP) added to standard care versus standard care plus conventional cognitive-behavioral therapy (CBT). The goal is to see if IATP leads to better outcomes in reducing pain and improving coping skills compared to CBT.

Participant Groups

Group I: STD+IATP Experimental Treatment 2 Interventions

Standard conservative dental orofacial pain care + Individualized Assessment and Treatment Program; a highly individualized coping skills training procedure.

Group II: STD+CBT Active Control 2 Interventions

Standard conservative dental orofacial pain care + cognitive-behavioral coping skills treatment

Who Is Running the Clinical Trial?

UConn Health

Lead Sponsor

Trials

218

Recruited

59,100+

National Institute of Dental and Craniofacial Research (NIDCR)

Collaborator

Trials

312

Recruited

853,000+

Findings from Research

In a study of 52 patients with temporomandibular disorders (TMDs), there was a significant discrepancy between doctors' and patients' assessments of treatment outcomes, with 44% of cases showing differing evaluations.

Doctors tended to rate patient improvement more positively than patients did, indicating that relying solely on physician assessments may not accurately reflect patient experiences and treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Global doctor opinion versus a patient questionnaire for the outcome assessment of treated temporomandibular disorder patients. Ness, GM., Laskin, DM.[2019]

A TMD-trained general dental practitioner was able to predict treatment outcomes for patients with temporomandibular disorders (TMD) with similar accuracy to a TMD specialist, achieving 100% improvement in patients predicted to have a 'Good' outcome.

In a comparison of treatment outcomes, the general dental practitioner showed high success rates (100% for Muscle symptoms and 100% for Mainly TMJ symptoms) in accurately predicting improvements, suggesting that training can enhance the effectiveness of general practitioners in managing TMD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of individual prediction of treatment outcome made by a TMD specialist and a TMD-trained general dental practitioner in patients with temporomandibular disorders. Sundqvist, B., Wenneberg, B., Magnusson, T.[2019]

Out of 1297 patients with temporomandibular disorders, 88% reported a significant improvement (50% or more) in their symptoms after treatment, indicating high efficacy of the treatment approach.

The ability to predict treatment outcomes was strong, with 90% of patients with muscular symptoms and 94% of those with TMJ symptoms achieving positive results when a good outcome was anticipated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individual prediction of treatment outcome in patients with temporomandibular disorders. Sundqvist, B., Magnusson, T.[2006]

A Delphi survey involving 23 international experts identified four key questionnaires and three pain screening tools as the most clinically useful for assessing temporomandibular disorders (TMD), emphasizing their reliability and validity.

The survey also highlighted eight essential physical examination tests, which can help clinicians effectively evaluate TMD, aligning with established diagnostic criteria and potentially guiding future research and policy decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

International consensus on the most useful assessments used by physical therapists to evaluate patients with temporomandibular disorders: A Delphi study. von Piekartz, H., Schwiddessen, J., Reineke, L., et al.[2020]

A study involving 2,187 patients with temporomandibular disorders (TMD) showed that continuous quality improvement in clinical routines significantly enhanced the prediction of treatment outcomes, with 90% of patients predicted to have a good outcome achieving a clinically important difference in symptom improvement.

In both patient groups (Muscle and Mainly TMJ symptoms), a high percentage of those predicted to have good outcomes reached significant symptom improvement, indicating that the prediction model was effective, and rheumatic disease did not negatively impact treatment success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation and improvement of a predictive model for treatment outcome in patients with temporomandibular disorders. Sundqvist, B., Wenneberg, B., Magnusson, T.[2019]

A review of 90 randomized clinical trials on treatments for temporomandibular disorders (TMDs) revealed that the quality of reporting on statistical methods and adverse events was generally poor, impacting the assessment of risk-to-benefit ratios.

While there was some improvement in reporting practices in newer studies (2006-2013) compared to older ones (1971-2005), critical details such as primary outcome analyses and methods for handling missing data were still inadequately reported, highlighting a need for better standards in clinical trial reporting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reporting of adverse events and statistical details of efficacy estimates in randomized clinical trials of pain in temporomandibular disorders: Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks systematic review. Gewandter, JS., Smith, SM., McKeown, A., et al.[2018]

The Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) has been developed to provide a reliable classification system for TMDs, incorporating a biopsychosocial model and demonstrating strong sensitivity and specificity for pain-related disorders.

The DC/TMD has been successfully integrated into the AAPT framework, which offers a structured approach for diagnosing and understanding TMDs and their comorbidities, paving the way for future research on orofacial pain conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

AAPT Diagnostic Criteria for Chronic Painful Temporomandibular Disorders. Ohrbach, R., Dworkin, SF.[2020]

In a long-term study involving 2104 treated and 250 untreated TMD patients, it was found that untreated TMD patients do not improve on their own, highlighting the necessity of treatment.

Patients who received various active treatments showed significant improvement without relapse, with anterior repositioning appliance therapy proving more effective than flat plane splint therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Temporomandibular disorder treatment outcomes: second report of a large-scale prospective clinical study. Brown, DT., Gaudet, EL.[2019]

The one-page screening process for temporomandibular disorders (TMD) is efficient and user-friendly, making it easy to implement in dental practices.

While the screening process is effective, it is essential to follow up with a thorough history review and clinical examination to ensure accurate diagnosis and appropriate treatment for the diverse range of TMDs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Temporomandibular disorders: a practical screening process. Kinderknecht, KE., Thomas, CA.[2015]

A study involving 145 patients with temporomandibular disorders (TMD) revealed significant variability in diagnosis and treatment approaches between two clinics, including differences in the use of imaging and treatment types.

Despite these differences in clinical practices, there were no significant variations in patient-reported pain and dysfunction after one year, highlighting the need for standardized treatment protocols in TMD management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Temporomandibular disorders. Variation in clinical practice. Von Korff, MR., Howard, JA., Truelove, EL., et al.[2019]

Physical therapy is essential in managing temporomandibular joint dysfunction (TMJD), particularly for treating stiffness following trauma.

Combining TMJ strapping with conventional physical therapy can effectively reduce clicking sounds, alleviate pain, and enhance jaw function in patients with TMJD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strapping for temporomandibular joint dysfunction. Babu, AS., John, SM., Unni, A.[2019]

In a large-scale study involving over 6,500 patients, those who received treatment for temporomandibular disorders (TMD) showed significant symptom improvement compared to untreated patients, who reported no changes.

The study utilized a validated symptom measurement system, the TMJ Scale, to ensure consistent assessment of treatment outcomes, reinforcing the conclusion that TMD does not improve spontaneously without intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Temporomandibular disorder treatment outcomes: first report of a large-scale prospective clinical study. Gaudet, EL., Brown, DT.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Global doctor opinion versus a patient questionnaire for the outcome assessment of treated temporomandibular disorder patients. [2019]

2. Sweden pubmed.ncbi.nlm.nih.gov

Comparison of individual prediction of treatment outcome made by a TMD specialist and a TMD-trained general dental practitioner in patients with temporomandibular disorders. [2019]

3. Sweden pubmed.ncbi.nlm.nih.gov

Individual prediction of treatment outcome in patients with temporomandibular disorders. [2006]

4. England pubmed.ncbi.nlm.nih.gov

International consensus on the most useful assessments used by physical therapists to evaluate patients with temporomandibular disorders: A Delphi study. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Validation and improvement of a predictive model for treatment outcome in patients with temporomandibular disorders. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Reporting of adverse events and statistical details of efficacy estimates in randomized clinical trials of pain in temporomandibular disorders: Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks systematic review. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

AAPT Diagnostic Criteria for Chronic Painful Temporomandibular Disorders. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Temporomandibular disorder treatment outcomes: second report of a large-scale prospective clinical study. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Temporomandibular disorders: a practical screening process. [2015]

10. United States pubmed.ncbi.nlm.nih.gov

Temporomandibular disorders. Variation in clinical practice. [2019]

11. India pubmed.ncbi.nlm.nih.gov

Strapping for temporomandibular joint dysfunction. [2019]

12. England pubmed.ncbi.nlm.nih.gov

Temporomandibular disorder treatment outcomes: first report of a large-scale prospective clinical study. [2019]