UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of Distraction osteogenesis for severe hypoplastic maxilla or mandible
Title of the study (Brief title)	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	Yoshimichi imai
Organization	Tohoku University Graduate School of Medicine
Division name	Department of Plastic and Reconstructive Surgery
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	Yoshimichi Imai
Organization	Tohoku University Graduate School of Medicine
Division name	Department of Plastic and Reconstructive Surgery
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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2010 Year 03 Month 29 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000005262