R01_Pilot Jaw Muscle Phenotypes
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Minnesota
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Provide signed and dated informed consent 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).
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Local Heat Therapy
Other interventionThis 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
Treatment groups
10 Participants
are divided into 2 treatment groupsGroup A: Self-care with local heat therapyActive comparator 1 intervention
Group B: Self-care without local heat therapyNo intervention 0 interventions
Trial outcomes
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 intervention2
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 interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: