UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical assessment of maxillary protraction with skeletal anchorage for skeletal Class III caused by maxillary retrognathism.
Title of the study (Brief title)	Clinical assessment of maxillary protraction with skeletal anchorage.
Region	Japan

Condition
Condition	Skeletal Class III caused by maxillary retrognathism
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Validation of efficacy for maxillary protraction with skeletal anchorage compared with conventional maxillary protraction.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	anterior-posterior variation of maxilla at one year later from start of maxillary protraction.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Maxillary protraction with skeletal anchorage
Interventions/Control_2	Maxillary protraction without skeletal anchorage
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	7 years-old <=
Age-upper limit	14 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Patients who visited the Okayama University Hospital Orthodontic clinic 2) Patients of skeletal Class III relationships with maxillary deficiency 3) Patients with Hellman's Dental age(IIIA) 4) Patients who got consent from relatives
Key exclusion criteria	1) Uncooperative patient 2) Patient with uncontrolled systemic disease 3) Patient with congenital syndrome 4) Patients who are judged that they are inadequate by principal investigator or members of this study
Target sample size	30

Research contact person
Name of lead principal investigator	Hiroshi Kamioka
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name	Department of Orthodontics
Address	2-5-1, Shikata-cho, Okayama city, Okayama,
TEL	086-235-6691
Email	kamioka@md.okayama-u.ac.jp

Public contact
Name of contact person	Masahiro Nakamura
Organization	Okayama University Hospital
Division name	Department of Orthodontics
Address	2-5-1, Shikata-cho, Okayama city, Okayama,
TEL	086-235-6796
Homepage URL
Email	nakamurama@okayama-u.ac.jp

Sponsor
Institute	Okayama university
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2019 Year 04 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2018 Year 11 Month 01 Day
Anticipated trial start date	2019 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 08 Month 03 Day
Last modified on	2018 Year 11 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038331