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Single-arm clinical study of orthodontic brackets with square slots

Single-arm clinical study to evaluate the clinical performance of orthodontic mini-brackets with a square slot in patients with anterior crowding

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1032240004
Enrollment
20
Registered
2024-04-03
Start date
2024-04-24
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

Patients who undergo orthodontic treatment for crowding

Interventions

To orthodontically treat the patients with passive self-ligation system with new standard square slots "ORIGAMI SL bracket"

Sponsors

Ono Takashi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients with anterior crowding 2) Patients with the following conditions (1) Arch length discrepancy less than -3.0 mm (2) ANB between 1.0 and 5.0 degrees (3) Deviation of the Menton less than 2.0 mm (4) Periodontal pocket depth less than 4.0 mm with no mobility 3) Patients aged between 18 and 40 years old 4) Patients with consent to participate in this clinical trial

Exclusion criteria

Exclusion criteria: 1) Patients with a history of orthodontic treatment 2) Patients with jaw deformity requiring a surgical intervention 3) Patients with moderate or severe alveolar bone resorption 4) Patients with an abnormal number of teeth (excluding third molars) 5) Patients with active periodontitis 6) Patients under medication related to bone metabolism (bisphosphonates etc.), steroids, sympathetic blockers, or antidepressants (at least 6 months drug cessation is acceptable) 7) Patients with severe mental disorders 8) Patients with a history of serious allergy to metals 9) Patients with a disease requiring urgent treatments or a serious complication 10) Patients in participation in research on other drugs, medical devices, or food products 11) Patients being pregnant or may become pregnant 12) Patients being breastfeeding 13) Other persons who are deemed by the principal investigator sub-investigator) to be inappropriate to participate in this trial

Design outcomes

Primary

MeasureTime frame
Crowding relief period

Secondary

MeasureTime frame
1) Tooth movement velocity (crown) (distance) 2) Tooth movement velocity (apex) (distance) 3) Tooth movement velocity (inclination) 4) Tooth movement velocity (rotation) 5) Crowding relief efficiency

Contacts

Public ContactYuji Ishida

Institute of Science Tokyo Hospital

origami-clinicaltrial@ml.tmd.ac.jp+81-3-5803-5528

Outcome results

None listed

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