UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026323 |
|---|---|
| Receipt number | R000030234 |
| Scientific Title | Verification clinical trial evaluating the effectiveness of low intensity pulsed ultrasound for jaw deformity and jaw bone fracture patients |
| Date of disclosure of the study information | 2017/02/28 |
| Last modified on | 2021/03/03 14:20:08 |
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Basic information
Public title
Verification clinical trial evaluating the effectiveness of low intensity pulsed ultrasound for jaw deformity and jaw bone fracture patients
Acronym
Clinical trial evaluating the effectiveness of LIPUS for jaw deformity and jaw bone fracture patients
Scientific Title
Verification clinical trial evaluating the effectiveness of low intensity pulsed ultrasound for jaw deformity and jaw bone fracture patients
Scientific Title:Acronym
Clinical trial evaluating the effectiveness of LIPUS for jaw deformity and jaw bone fracture patients
Region
| Japan |
Condition
Condition
jaw deformity and jaw bone fracture patients
Classification by specialty
| Oral surgery | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is to irradiate LIPUS and observe bone heling for the jaw deformity patient and the jaw bone fracture patient who underwent an invasive procedure.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Presence or absence of bone healing at 3 months after surgery
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
It consisted of a total of 1 year, 1 week of observation period, 3 months of LIPUS irradiation period, 3 months of post observation period and 6 months of follow-up period. The patients visit our hospital for every 4 weeks until the 6th month, and every 3 months from 6 months to 1 year.
During the LIPUS irradiation period, LIPUS is irradiated to the skin of the bone fracture surface once a day for 20 minutes from the second day after the operation.
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Jaw deformity or jaw bone fracture patient who underwent an invasive procedure
Patients who obtained document agreement by their voluntary free will concerning participation in this exam
Key exclusion criteria
Patients with drug hypersensitivity such as allergies
In addition, patients judged inappropriate by the doctor in charge of this study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takumi |
| Middle name | |
| Last name | Takumi |
Organization
Kobe University Graduate School of Medicine
Division name
Department of Oral and Maxillofacial Surgery
Zip code
650-0017
Address
7-5-1, Kusunoki-cho, Chuo-ku, Kobe 650-0017
TEL
078-382-6213
komori@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Takumi |
| Middle name | |
| Last name | Hasegawa |
Organization
Kobe University Graduate School of Medicine
Division name
Department of Oral and Maxillofacial Surgery
Zip code
650-0017
Address
7-5-1, Kusunoki-cho, Chuo-ku, Kobe 650-0017
TEL
078-382-6213
Homepage URL
hasetaku@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe University Clinical Research Ethical Committee
Address
7-5-1, Kusunoki-cho, Chuo-ku, Kobe
Tel
078-382-6669
cerb@med.kobe-u.ac.jp
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
| 2017 | Year | 02 | Month | 28 | Day |
Related information
URL releasing protocol
none
Publication of results
Unpublished
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
1
Results
None
Results date posted
| 2021 | Year | 03 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Jaw deformity or jaw bone fracture patient who underwent an invasive procedure
Participant flow
Patients who obtained document agreement by their voluntary free will concerning participation in this exam
Adverse events
None
Outcome measures
Presence or absence of bone healing at 3 months after surgery
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2017 | Year | 02 | Month | 28 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 30 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 05 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 02 | Month | 27 | Day |
Last modified on
| 2021 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030234
