UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy of artificial bone grafting in secondary bone graft for alveolar cleft.
Acronym	Efficacy of artificial bone grafting for alveolar cleft.
Scientific Title	Efficacy of artificial bone grafting in secondary bone graft for alveolar cleft.
Scientific Title:Acronym	Efficacy of artificial bone grafting for alveolar cleft.
Region	Japan

Condition
Condition	alveolar cleft
Classification by specialty	Plastic surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the efficacy of artificial bone grafting with micrograft in secondary bone grafting for alveolar cleft.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Osteogenesis after artificial bone grafting with micrograft in secondary bone grafting for alveolar cleft.
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	7 years-old <=
Age-upper limit	12 years-old >=
Gender	Male and Female
Key inclusion criteria	Alveolar cleft patients
Key exclusion criteria	Re-operation patients
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Motoki Middle name Last name Katsube
Organization	Kyoto University Hospital
Division name	Plastic and Reconstructive Surgery
Zip code	606-8507
Address	54 Kawaharacho, Shogoin, Sakyo-ku, Kyoto
TEL	075-751-3613
Email	katsube@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	1st name Motoki Middle name Last name Katsube
Organization	Kyoto University Hospital
Division name	Plastic and Reconstructive Surgery
Zip code	606-8507
Address	54 Kawaharacho, Shogoin, Sakyo-ku, Kyoto
TEL	075-751-3613
Homepage URL
Email	katsube@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Kyoto University
Institute
Department

Funding Source
Organization	Kyoto University
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	Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address	Yoshida-Konoe-cho, Sakyo-ku, Kyoto
Tel	075-753-4680
Email	ethcom@kuhp.kyoto-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	2021 Year 05 Month 21 Day

Related information
URL releasing protocol
Publication of results	Unpublished

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	Preinitiation
Date of protocol fixation	2021 Year 05 Month 21 Day
Date of IRB
Anticipated trial start date	2021 Year 07 Month 01 Day
Last follow-up date	2024 Year 07 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	None

Management information
Registered date	2021 Year 05 Month 21 Day
Last modified on	2021 Year 05 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050583