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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000004402
Receipt No. 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

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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
Email 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
Email yo-imai@med.tohoku.ac.jp

Sponsor
Institute Tohoku University Graduate School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005262

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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