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The Effect of Manual Physical Therapy and Exercise in Addition to Routine Dental Care in Individuals With Temporomandibular Disorders

NCT06602375 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-02-05

No results posted yet for this study

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.

Conditions

  • Temporomandibular Disorders (TMD)

Interventions

OTHER

Standard care

The standard care (control) group will follow the plan of care determined by their treating dental provider. These decisions will be based on the clinical judgment of the dental provider and subject desires. Intervention may include, but is not limited to typical patient education, pharmacotherapy, oral splinting or occlusal device, cryo/thermotherapy recommendations, and exercise handouts.

OTHER

Physical Therapy (PT)

Participants randomized to this group will receive individualized, tailored courses of physical therapy care. Interventions may be directed at the temporomandibular, cervical, and/or scapulothoracic regions based on subject clinical presentation and impairments. Manual therapy joint and soft tissue mobilizations may be used to address pain, mobility, and motor control. Motor control exercises may be used to promote relaxation, improve range of motion, and appropriate postures. Strengthening exercise, primarily directed to the cervical and scapulothoracic regions, may be implemented as appropriate. Stretching exercise may be used to address pain and mobility deficits. The interventions are intentionally pragmatic; study participants will receive treatment as they are comfortable and as recommended by the treating therapist.

Sponsors & Collaborators

  • Brooke Army Medical Center

    lead FED

Principal Investigators

  • Benjamin R Hando, PhD, DPT · Army-Baylor Doctoral Fellowship in Orthopedic Manual Physical Therapy, Brooke Army Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-16
Primary Completion
2025-06-30
Completion
2026-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06602375 on ClinicalTrials.gov