Clinical evaluation of custom-made brackets

JRCT ID: jRCTs022230061

Registered date:21/02/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: malocclusion
• Date of first enrollment: 21/02/2024
• Target sample size: 26
• Study type: Interventional
• Intervention(s): Orthodontic treatment

Outcome(s)

• Primary Outcome: duration of orthodontic treatment

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 13age old
• Age maximum: <= 30age old
• Gender: Both

Include 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 30 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.)

Exclude 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

Related Information

• Primary Sponsor: Kanetaka Hiroyasu
• Source(s) of Monetary Support: EH Japan Co., Ltd.