UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033620 |
|---|---|
| Receipt number | R000038331 |
| Scientific Title | Clinical assessment of maxillary protraction with skeletal anchorage for skeletal Class III caused by maxillary retrognathism. |
| Date of disclosure of the study information | 2019/04/01 |
| Last modified on | 2018/11/02 09:51:04 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Clinical assessment of maxillary protraction with skeletal anchorage for skeletal Class III caused by maxillary retrognathism.
Acronym
Clinical assessment of maxillary protraction with skeletal anchorage.
Scientific Title
Clinical assessment of maxillary protraction with skeletal anchorage for skeletal Class III caused by maxillary retrognathism.
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Hiroshi Kamioka |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Orthodontics
Zip code
Address
2-5-1, Shikata-cho, Okayama city, Okayama,
TEL
086-235-6691
kamioka@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiro Nakamura |
Organization
Okayama University Hospital
Division name
Department of Orthodontics
Zip code
Address
2-5-1, Shikata-cho, Okayama city, Okayama,
TEL
086-235-6796
Homepage URL
nakamurama@okayama-u.ac.jp
Sponsor or person
Institute
Okayama university
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2018 | Year | 11 | Month | 01 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038331
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
