UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027392
Receipt No. R000031316
Scientific Title Study on the effects of hydroxyapatite (HA) and artificial bone prosthesis made of beta-TCP in implant treatment (randomized controlled trial)
Date of disclosure of the study information 2017/05/31
Last modified on 2017/05/18

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Middle name
Last name Fumio Suehiro
Organization Graduate School of Medical and Dental Sciences, Kagoshima University
Division name Department of Oral and Maxillofacial Prosthodontics
Zip code
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
Middle name
Last name Fumio Suehiro
Organization Graduate School of Medical and Dental Sciences, Kagoshima University
Division name Department of Oral and Maxillofacial Prosthodontics
Zip code
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
Address
Tel
Email

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
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 Open public recruiting
Date of protocol fixation
2016 Year 02 Month 09 Day
Date of IRB
Anticipated trial start date
2017 Year 05 Month 31 Day
Last follow-up date
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
2017 Year 05 Month 18 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.