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Clinical evaluation of custom-made brackets

An open-label, randomized controlled trial investigating the effect of shortening the duration of orthodontic treatment using a custom-made bracket system

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs022230061
Enrollment
26
Registered
2024-02-21
Start date
2024-02-21
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

malocclusion

Interventions

Orthodontic treatment

Sponsors

Kanetaka Hiroyasu
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Patients who voluntarily consented in writing to participate in this clinical trial (parental authority for minors) (2) Malocclusion (excluding skeletal malocclusion requiring orthodontic treatment) and no congenital anomalies. (3) Male and Female between the ages of 13 and 37 at the time of informed consent (4) Patients who are judged to have finished or about to finish pubertal growth. (Determined by X-rays of carpal bones, etc.)

Exclusion criteria

Exclusion criteria: (1) Jaw deformity patients and congenital syndrome patients (2) Patients intended for stage I treatment (3) Patients who have experienced orthodontic treatment (4) Patients who are expected to have difficulty in continuing treatment at Tohoku University Hospital until the end of treatment (5) Patients with vomiting reflex that makes impression taking difficult (6) Female who are pregnant, may be pregnant, have given birth within 28 days, or are breastfeeding (7) Patients who are considered difficult to participate in the study due to complication of psychosis or psychiatric symptoms (8) In addition, patients who are judged to be inappropriate as subjects by the principal investigator or co-investigator

Design outcomes

Primary

MeasureTime frame
duration of orthodontic treatment

Secondary

MeasureTime frame
The number of visits during the treatment period Time spent on bonding Bracket dropout rate Study model evaluation before and after treatment Concordance rate with treatment goals VAS score Evaluation of occlusal stability one year after device removal

Contacts

Public ContactArata Ito

Tohoku University Hospital

arata.ito.c7@tohoku.ac.jp+81-22-717-8376

Outcome results

None listed

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