UMIN-CTR Clinical Trial

Basic information
Public title	Study on the effects of hydroxyapatite (HA) and artificial bone prosthesis made of beta-TCP in implant treatment (randomized controlled trial)
Acronym	Study on the effects of artificial bone prosthesis (HA and beta-TCP) in implant treatment
Scientific Title	Study on the effects of hydroxyapatite (HA) and artificial bone prosthesis made of beta-TCP in implant treatment (randomized controlled trial)
Scientific Title:Acronym	Study on the effects of artificial bone prosthesis (HA and beta-TCP) in implant treatment
Region	Japan

Condition
Condition	patients with bone defect
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To estimate the effects of artificial bone prosthesis for bone augmentation
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	survival rate after one year of the dental implant placed in the augmented bone
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Duration:1 year Bone formation using cerasorb or Arrowbone beta dental at the same time as the dental implant placement or 2nd term is performed and bone level is confirmed by dental radiograph 1 year after implant placement.
Interventions/Control_2	Duration:1 year Bone formation using neobone at the same time as the dental implant placement or 2nd term is performed and bone level is confirmed by dental radiograph 1 year after implant placement.
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	patients with albeolar bone defect
Key exclusion criteria	patient with poor general condition
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Fumio Middle name Last name Suehiro
Organization	Graduate School of Medical and Dental Sciences, Kagoshima University
Division name	Department of Oral and Maxillofacial Prosthodontics
Zip code	8908544
Address	8-35-1 Sakuragaoka, Kagoshima 890-8544
TEL	099-275-6222
Email	fsuehiro@dent.kagoshima-u.ac.jp

Public contact
Name of contact person	1st name Fumio Middle name Last name Suehiro
Organization	Graduate School of Medical and Dental Sciences, Kagoshima University
Division name	Department of Oral and Maxillofacial Prosthodontics
Zip code	8908544
Address	8-35-1 Sakuragaoka, Kagoshima 890-8544
TEL	099-275-6222
Homepage URL
Email	fsuehiro@dent.kagoshima-u.ac.jp

Sponsor
Institute	Graduate School of Medical and Dental Sciences, Kagoshima University
Institute
Department

Funding Source
Organization	Kagoshima 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	Kagoshima University hospital, Division of clinical trial
Address	8-35-1 Sakuragaoka, Kagoshima 890-8544
Tel	0992755553
Email	crmc@m2.kufm.kagoshima-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 05 Month 31 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	9
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	Completed
Date of protocol fixation	2016 Year 02 Month 09 Day
Date of IRB	2016 Year 12 Month 05 Day
Anticipated trial start date	2017 Year 05 Month 31 Day
Last follow-up date	2018 Year 12 Month 27 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 05 Month 18 Day
Last modified on	2019 Year 11 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031316