A clinical trial investigating the effectiveness of a new tooth- and bone-borne rapid expansion device

JRCT ID: jRCTs062210075

Registered date:16/02/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Jaw deformity
• Date of first enrollment: 16/02/2022
• Target sample size: 10
• Study type: Interventional

Intervention(s)

After confirming the implantation position of the dual top autoscrew III by CBCT examination at baseline, implantation will be performed.(Implantation will be handled by an orthodontist who is a skilled orthodontist.) Approximately 3 weeks later, after confirming the stability of the screw, an impression will be taken, a new expansion device is created on the working model, and it is attached to the research subject. If the screw is not stable, re-implant in another site or re-implant after healing period of 3 months.
The attached new expansion device is rotated twice a day (2/4 rotations) every night by the research subject or his / her guardian. In the case of normal medical care, the visit interval is once a month, but in order to check the expansion status, the visit is made after 5 days of expansion. At that time, the dehiscence of the median suture is confirmed by the occlusal X-ray examination, and if the dehiscence can be confirmed, the expansion is continued to the target expansion amount. If the detachment cannot be confirmed, the expansion is stopped and the device is removed.
An examination will be conducted at the end of expansion at the time of visit one month after the device is attached. The new expansion device will be used as a retention device and will remain attached to the oral cavity after the end of the expansion, and the follow-up will be performed until 6 months after the end of the expansion.

Outcome(s)

• Primary Outcome: success rate of the midpalatal suture opening

Secondary Outcome

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)
2) Adverse events caused by study treatment up to 6 months after the end of expansion
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.)

Key inclusion & exclusion criteria

• Age minimum: >= 15age old
• Age maximum: <= 29age old
• Gender: Both

Include criteria

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

Exclude criteria

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

Related Information

• Primary Sponsor: Kamioka Hiroshi