NCT06602375 The Effect of Manual Physical Therapy and Exercise in Addition to Routine Dental Care in Individuals With Temporomandibular Disorders
| NCT ID | NCT06602375 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Brooke Army Medical Center |
| Condition | Temporomandibular Disorders (TMD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-09-16 |
| Primary Completion | 2025-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2024-09-16 with a primary completion date of 2025-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this randomized clinical trial among US military active-duty service-members with temporomandibular disorders (TMD) is to determine whether standard care plus 6-weeks of tailored, individualized physical therapy (PT) treatment provides greater benefit than standard care alone in patient-reported outcomes, and maximal mouth opening. The aims of the study are to compare outcomes in individuals with TMD that receive standard care treatment versus standard care plus PT interventions at 0-, 6-, and 12-weeks. The investigators anticipate that subjects in the standard care plus PT group will exhibit improved patient-reported outcomes, and maximal mouth opening compared to those who received standard care alone. Additionally, the investigators will compare the amount and type of healthcare utilization between the two groups (Standard Care and Standard Care + PT) in the 12-month period following enrollment in the study. All participants will be managed by their primary dental provider and receive care as deemed appropriate by their provider. All participants will complete patient-reported outcome measures and have their jaw motion measured. Those randomized to the standard care plus PT group will also receive a tailored PT evaluation followed by an individualized plan of care two times per week for up to six weeks.
Eligibility Criteria
Inclusion Criteria: * Active-Duty Service Members * Complaint of TMD symptoms * Must be able to be followed for twelve weeks after consent * TMD Screener score ≥ 3 45 Exclusion Criteria: * Actively in a Trainee status * Utilized oral device in past 6 months * Facial injection therapy in the prior 6 months * Facial surgery in the preceding 6 months * Serious spinal pathology (acute fracture, active cancer, instability) * Diagnosed neurological or rheumatological disease * Currently under litigation related to temporomandibular or cervical spine pain(s) * Currently undergoing Medical Evaluation Board (MEB) * Retiring or separating from the military within a year
Contact & Investigator
Benjamin R Hando, PhD, DPT
STUDY CHAIR
Army-Baylor Doctoral Fellowship in Orthopedic Manual Physical Therapy, Brooke Army Medical Center
Frequently Asked Questions
Who can join the NCT06602375 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 55 Years, studying Temporomandibular Disorders (TMD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06602375 currently recruiting?
Yes, NCT06602375 is actively recruiting participants. Contact the research team at mason.a.frank.mil@health.mil for enrollment information.
Where is the NCT06602375 trial being conducted?
This trial is being conducted at Fort Sam Houston, United States.
Who is sponsoring the NCT06602375 clinical trial?
NCT06602375 is sponsored by Brooke Army Medical Center. The principal investigator is Benjamin R Hando, PhD, DPT at Army-Baylor Doctoral Fellowship in Orthopedic Manual Physical Therapy, Brooke Army Medical Center. The trial plans to enroll 60 participants.