Clinical trial evaluating the effectiveness of LIPUS for jaw deformity patients

JRCT ID: jRCTs052180090

Registered date:04/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: jaw deformity
• Date of first enrollment: 05/12/2017
• Target sample size: 65
• Countries of recruitment: Not applicable,Japan
• Study type: Interventional
• Intervention(s): Exposure of low intensity pulsed ultrasound (LIPUS) once a day, 20 minutes, for 1 month from the surface of the skin of fracture.

Outcome(s)

• Primary Outcome: Presence or absence of bony healing at 3 months after surgery

Secondary Outcome

1. Presence or absence of bone union at 6 months after operation and 1 year after operation,
2. Safety, adverse events, and symptoms at 1 month, 6 months, 1 year after surgery,
3. The length of back over after jaw deformity surgery 1 year after surgery (overjet, overbite, median deviation),
4. Opening amount at one year after surgery after operation of jaw deformity,
5. Intermaxillary fixation period, the duration of hospital stay,
6. Costs related to hospitalization

Key inclusion & exclusion criteria

• Age minimum: >= 16age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Jaw deformity patients who underwent an invasive procedure
2) Patients who are 16 years of age or older at the time of consent acquisition
3) Gender: No prejudice
4) Hospitalization / Outpatient
5) With regard to participation in this examination, patients who gained document consent by their own voluntary intention

Exclude criteria

Patients with drug hypersensitivity such as allergies,
Patients with infected wounds,
Patients wearing specific implantable electronic devices such as pacemakers,
Ischemic tissue,
Patients with unknown acute (painful) disease,
Patients with heart problems,
Patients with high hemorrhagic diathesis,
Patients with malignant tumors,
Skin injury, inflamed site,
Infectious disease patients,
On the carotid sinus,
Other patients judged inappropriate by the physician in charge of this study

Related Information

• Primary Sponsor: Hasegawa Takumi
• Secondary ID(s): UMIN00026323