ClinicalTrials.gg
RecruitingNCT07153107Updated Oct 23, 2026

R01_Pilot Jaw Muscle Phenotypes

An interventional study of Local Heat Therapy in Chronic TMD Pain and Temporomandibular Disorder, sponsored by University of Minnesota. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.

Sponsored by University of Minnesota · Not applicable, Interventional, and Basic science

Updated Oct 23, 2026Now RecruitingSite recruiting status changed+1 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The proposed study will assess the effect of local heat therapy on jaw pain and jaw fatigue secondary to a teeth clenching task in chronic TMD pain cases. Researchers expect that most participants will respond to heat therapy and consequently experience reduced jaw pain and fatigue during teeth clenching. The study will assess the clinical characteristics of those participants who respond and do not respond to local heat therapy, in order to determine the common clinical characteristics for those in each response category.

02

Conditions studied

  • Chronic TMD Pain
  • Temporomandibular Disorder

Keywords

  • Jaw Pain
  • Local Heat Therapy
03

In context

Temporomandibular Joint Disorders

591 studies on the registry are indexed under Temporomandibular Joint Disorders; 149 are open to participants now.

This study's planned enrollment of 10 is below the median of 45 across 415 interventional studies indexed under Temporomandibular Joint Disorders.

Browse Temporomandibular Joint Disorders studies →

Lead sponsor

University of Minnesota is the lead sponsor of 1,216 studies on the registry; 197 are open to participants now.

Of its 136 completed or terminated interventional studies of FDA-regulated products, 95 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Provide signed and dated form.
  • Willing to comply with all study procedures and be available for the duration of study participation.
  • Be 18 years or older.
  • Have a minimum set of teeth present, be it natural, implant-supported or fixed prosthodontics: all anterior teeth (incisors, canines), at least one premolar, at least one molar (first or second molar; third molars not considered).
  • TMD-Pain screener score equal to or greater than 3
  • Myalgia (masticatory muscle pain) based on clinical exam following the DC/TMD protocol
  • Concurrent arthralgia (TMJ pain) and/or headache attributed to TMD allowed
  • Myofascial pain must meet the following criteria:

    1. Onset >3 months, occurring >15 days/month on average in the last three months from the screening session
    2. Minimum of 10 jaw pain episodes since onset, each episode lasting at least 30 minutes and no less than 2 hours within the day, OR unremitting

Exclusion criteria

Exclusion Criteria:

  • Traumatic facial injury or surgery on the face/jaw, arms or hands;
  • Presence of pain related to dental and periodontal pathology;
  • Currently undergoing active orthodontic treatment;
  • Pregnant;
  • Has any of the following medical conditions by self-report:

    1. Renal failure or dialysis,
    2. Heart disease (examples: uncontrolled arrythmia or hypertension, cardiomyopathy) or heart failure, Non-allergic bronchospasm ( and emphysema),
    3. Diabetes (type I or II) that is not controlled with medication or diet,
    4. Hyperthyroidism,
    5. Uncontrolled seizures;
  • Used any injection therapy (e.g., tender or trigger point injections, injections), acupuncture, biofeedback, or TENS for the management of facial/jaw pain within 2 weeks prior to the screening assessment; If undergoing botulinum toxin injections in the head and neck area, must be 3 months since last set of injections and refrain from this treatment until study participation has ended
  • History of major depression or other major psychiatric disorder requiring hospitalization within the last 6 months prior to the screening assessment;
  • History of treatment for drug or alcohol abuse within the last 12 months;
  • Current pain medication use (e.g., opioids, ibuprofen, acetaminophen) that cannot be stopped \<24 hours prior to each study visit;
  • Current use of medically prescribed muscle relaxants for the duration of study participation;
  • Other conditions/diseases associated with altered pain perception: neurological or development disorders (dementia, autism spectrum disorder), neoplasm, multiple sclerosis, trigeminal neuralgia;
  • Adults lacking capacity to provide for themselves;
  • Unable to understand instructions for study procedures in English.
  • Anything that would place the individual at increased risk or preclude the individual's full compliance with study procedures or completion of the study."
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
10 participants (estimated)

Study arms

  • Active comparator
    Self-care with local heat therapy

    Other: Local Heat Therapy

  • No intervention
    Self-care without local heat therapy

Interventions

  • OtherLocal Heat Therapy

    This will use a simple device provided to participants named "jaw bra", which is a head wrap with straps that goes around the chin and head that holds heated gel packs over the cheeks area

06

What researchers measure

Primary outcomes

  1. Proportion of bad jaw pain fluctuations

    Primary outcome includes the proportion of bad jaw pain fluctuations. A bad jaw pain fluctuation is defined as an increase ≥ 20 points from a previous measure. Jaw pain ratings will be collected daily for 8 days. The proportion of pain fluctuations is defined as the number of bad jaw pain fluctuations relative to the total number of jaw pain ratings.

    Time frame: 7 days following intervention

  2. Patient change in proportion of bad jaw pain fluctuations

    Patient change in proportion of bad pain fluctuations will be assessed by comparing the proportion of bad jaw pain fluctuations between patients receiving heat therapy and matched patients not receiving heat therapy during the wait period.

    Time frame: 7 days following intervention

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2026 (actual). Primary completion is estimated for Jan 2027, 2 months after the start.

Of 242 non-industry interventional studies with no phase under Temporomandibular Joint Disorders, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 21. This study's planned 2 months is below that.

Counting every sponsor, half of 246 studies reached it within 10 months; a quarter within 5 and three quarters within 21.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 25, 2025
First posted
Sep 3, 2025
StartActual
Oct 20, 2026
Primary completionEst.
Jan 12, 2027
CompletionEst.
Jan 12, 2027
Last update
Oct 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Oct 23, 2026
Sites
University of Minnesota is now Recruiting
Oct 23, 2026
Start date
Oct 1, 2026→Oct 20, 2026
Oct 2, 2026
Show all 2 updates
  1. Oct 23, 2026
    Not yet recruiting→Recruiting
    University of Minnesota is now Recruiting
    + 1 other change: date precision
  2. Oct 2, 2026
    Start date Oct 1, 2026→Oct 20, 2026
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07153107
Responsible party
Sponsor
First posted
Sep 3, 2025
Start date
Oct 20, 2026
Primary completion
Jan 12, 2027 (estimated)
Completion
Jan 12, 2027 (estimated)
Last update
Oct 23, 2026

Study contacts

Lauren Huffman
Contact
huffm052@umn.edu
612-625-8926
Estephan Moana-Filho
principal investigator · University of Minnesota

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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