臨床研究等提出・公開システム

Japanese

Date of registration	Feb. 21, 2024
Last modified on	Jan. 17, 2025
Trial ID	jRCTs022230061

Scientific Title	An open-label, randomized controlled trial investigating the effect of shortening the duration of orthodontic treatment using a custom-made bracket system
Public Title	Clinical evaluation of custom-made brackets

Contact for Scientific Queries	Name	Kanetaka Hiroyasu
	Affiliation	Tohoku University Hospital
	Address	1-1 Seiryo-cho, Aoba-ku, Sendai, Japan
	Telephone	+81-22-717-8419
	E-mail	kanetaka@dent.tohoku.ac.jp
Contact for Public Queries	Name	Itagaki Yusuke
	Affiliation	Tohoku University Hospital
	Address	1-1 Seiryo-cho, Aoba-ku, Sendai, Japan
	Telephone	+81-22-717-8277
	E-mail	yusuke.itagaki.b5@tohoku.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Feb. 21, 2024
Actual date of first enrollment
Target sample size		26
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	active control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion 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 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.)
	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
	Age Minimum	13age old over
	Age Maximum	30age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		malocclusion
Intervention(s)		Orthodontic treatment
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		duration of orthodontic treatment
Secondary Outcome(s)		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

Primary Sponsor

Primary Sponsor

Source of Monetary Support / Secondary Sponsor	EH Japan Co., Ltd.
Secondary Sponsor	Not applicable

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Tohoku Certified Review Board of Tohoku University
Address	1-1 Katahira 2-chome, Aoba-ku, Sendai, Miyagi
Telephone	+81-22-718-0461
E-Mail	office@nrs.hosp.tohoku.ac.jp
Approval Status	Approval
Date of approval	Sept. 26, 2023

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	Jan. 17, 2025	(this page)	Changes
1	Feb. 21, 2024	Detail

List of change history