UMIN-CTR Clinical Trial

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
Email	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
Email	hasetaku@med.kobe-u.ac.jp

Sponsor
Institute	Kobe University Graduate School of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030234