A clinical trial investigating the effectiveness of a new tooth- and bone-borne rapid expansion device
- Conditions
- Jaw deformitymaxillary transverse deficiencyD007569
- Registration Number
- JPRN-jRCTs062210075
- Lead Sponsor
- Kamioka Hiroshi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 10
1) patients with jaw deformities with severe maxillary transverse deficiency between the ages of 15 and 29
2) Person who obtained document consent by the patient's or legal representative's free will
1) Patients who cannot obtain cooperation for treatment
2) Patients who have extremely poor oral hygiene
3) Patients with unmanageable severe systemic disease, bleeding disease, endocrine disease
4) Patients with or have a history of drug, alcohol, or nicotine addiction
5) Patients with diseases that require regular steroid administration
6) Patients receiving bisphosphonates
7) Patients with xerostomia, opportunistic immunodeficiency or leukocyte dysfunction
8) Patients with hypersensitivity to pure titanium / titanium alloy, Nikel
9) Patients with lesions such as inflammation and tumor in the area around the screw planting
10) In addition, patients who are judged by the principal investigator and the investigator to be inappropriate as research subjects
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method success rate of the midpalatal suture opening
- Secondary Outcome Measures
Name Time Method 1) the amount of a change in midpalatal suture, maxillary intercanine, and intermolar width after the end of expansion compared to pre-treatment (unit: mm)<br>2) Adverse events caused by study treatment up to 6 months after the end of expansion<br>3) Defects in the test equipment up to 6 months after the end of expansion (falling / breaking rate of orthodontic anchor screws, deformation rate of orthodontic appliances, etc.)