UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004402 |
|---|---|
| Receipt number | R000005262 |
| Scientific Title | Evaluation of Distraction osteogenesis for severe hypoplastic maxilla or mandible |
| Date of disclosure of the study information | 2010/11/01 |
| Last modified on | 2017/04/23 10:23:10 |
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Basic information
Public title
Evaluation of Distraction osteogenesis for severe hypoplastic maxilla or mandible
Acronym
Evaluation of Distraction osteogenesis for severe hypoplastic maxilla or mandible
Scientific Title
Evaluation of Distraction osteogenesis for severe hypoplastic maxilla or mandible
Scientific Title:Acronym
Evaluation of Distraction osteogenesis for severe hypoplastic maxilla or mandible
Region
| Japan |
Condition
Condition
Hypoplastic maxilla, hypoplastic mandible
Classification by specialty
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Maxillary distraction using halo-type devices has been a breakthrough in LeFort I maxillary advancement for cleft cases, because of the possibilities for three-dimensional correction of the hypoplastic maxilla and the stability of the advanced maxillary segment. In addition, together with the RED Retention Plate System, it allows control of the palatal plane easily during the distraction. We have reported these advantages of halo type distraction technique, but we have begun to notice the possibility that LeFort I advancement deteriorates the patient's velopharyngeal function in some cases. Furthermore, the skeletal correction with LeFort I advancement for the hypoplastic maxilla is achieved simply by forcing the small maxillary dental arch to be set for the normal size dental arch of the mandible. Therefore, some of the molars are not involved in occlusion in some cases. To improve these problems, we adopted anterior maxillary distraction osteogenesis (AMDO), similar to interdental distraction osteogenesis, for the cleft cases that exhibited severe hypoplastic maxilla and marginal velopharyngeal insufficiency. Even though AMDO has some problems yet, we expect it could be an alternative to LeFort I advancement for cleft cases. And we have also treated hemifacial microsomia cases using distraction osteogenesis technique. However it has been controversial whether mandibular distraction was effective or mandibular and maxillary distraction was necessary. To make clear the effects of distraction osteogenesis for maxillary or mandibular deformities, we are examining the records of the cases retrospectively.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
evaluation at a month, 6months, 12months after the operation
complication
occlusion
collapse of distracted segments
velopharyngeal function
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Patients treated using distraction osteogenesis technique at Tohoku University Hospital in Sendai, Japan from 2000 to 2009 were included.
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
over 1 year follow up
Key exclusion criteria
drop out until 1 year postoperative
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshimichi imai |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Plastic and Reconstructive Surgery
Zip code
Address
Seiryo-machi 2-1, Aoba-ku, Sendai, Miyagi-pref., JAPAN
TEL
022-717-7332
yo-imai@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshimichi Imai |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Plastic and Reconstructive Surgery
Zip code
Address
Seiryo-machi 2-1, Aoba-ku, Sendai, Miyagi-pref., JAPAN
TEL
022-717-7332
Homepage URL
yo-imai@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
YES
Study ID_1
2009-518
Org. issuing International ID_1
Ethics Committee, Tohoku University School of Medicine
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Main results already published
Date of protocol fixation
| 2010 | Year | 03 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2010 | 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
| 2010 | Year | 10 | Month | 18 | Day |
Last modified on
| 2017 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005262
