Single-arm clinical study of orthodontic brackets with square slots

JRCT ID: jRCT1032240004

Registered date:03/04/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients who undergo orthodontic treatment for crowding
• Date of first enrollment: 24/04/2024
• Target sample size: 20
• Study type: Interventional
• Intervention(s): To orthodontically treat the patients with passive self-ligation system with new standard square slots "ORIGAMI SL bracket"

Outcome(s)

• Primary Outcome: Crowding relief period

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 40age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Ono Takashi