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UMIN-CTR Clinical Trial |
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Name: | 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 |
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 |
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Condition | ||
Condition | Hypoplastic maxilla, hypoplastic mandible | |
Classification by specialty |
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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 |
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Interventions/Control_1 | Patients treated using distraction osteogenesis technique at Tohoku University Hospital in Sendai, Japan from 2000 to 2009 were included. | |
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Eligibility | ||||
Age-lower limit |
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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 |
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Name of lead principal investigator |
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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 |
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Name of contact person |
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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 | |
Institute | Tohoku University Graduate School of Medicine |
Institute | |
Department |
Funding Source | |
Organization | None |
Organization | |
Division | |
Category of Funding Organization | Self funding |
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IRB Contact (For public release) | |
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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 |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Partially published |
Result | |
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Baseline Characteristics | |
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Progress | |||||||
Recruitment status | Main results already published | ||||||
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Last modified on |
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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 |