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

A clinical trial investigating the effectiveness of a new tooth- and bone-borne rapid expansion device in patients with jaw deformities with severe maxillary transverse deficiency

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs062210075

Enrollment

Registered

2022-02-16

Start date

2022-02-16

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Jaw deformity maxillary transverse deficiency

Interventions

After attaching the new expansion device, implantation will be performed by a skilled faculty oral surgeon. The implantation position of the Dual Top Autoscrew III will be confirmed using baseline CBC

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
success rate of the midpalatal suture opening	—

Secondary

Measure	Time frame
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.)	—

Measure

Time frame

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.)

—

Contacts

Public ContactMasahiro Nakamura

Okayama University Hospital

nakamurama@okayama-u.ac.jp+81-86-235-6692

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026