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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000042854
Receipt No. R000048917
Scientific Title Effect of beta-TCP on bone grafting
Date of disclosure of the study information 2020/12/25
Last modified on 2020/12/25

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Basic information
Public title Using of beta-tricalcium phosphate-based bone grafting material before and during the primary implant placement
Acronym Bone graft using beta-TCP
Scientific Title Effect of beta-TCP on bone grafting
Scientific Title:Acronym Effect of beta-TCP
Region
Japan

Condition
Condition missing tooth
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Implant treatment has become widespread in recent years due to its good prognosis and high predictability. However, there are many cases in which bone augmentation must be performed for implant placement due to insufficient bone mass. It goes without saying that autologous bone is the gold standard for bone graft materials, but autologous bone graft has various problems related to the donor site. Although iliac bone grafts can collect a large amount of autologous bone, the invasion is large and requires hospitalization. In addition, the chin, posterior acetabulum, and ramus of the mandible in the oral cavity are not as invasive as iliac transplantation, but the amount of bone volume is limited. Currently, there are only a handful of artificial bone filling materials in the dental field approved by the Ministry of Health, Labor and Welfare, and most of them are mainly composed of hydroxyapatite. Regarding beta-type TCP, Osferion, which has been sold by Olympus Corporation since 1999, is used in the field of orthopedics. It goes without saying that its safety is solid, but the current situation is that there is no approval from the Ministry of Health, Labor and Welfare regarding the use of the dental field. It has been reported that beta-type TCP is characterized by gradually replacing bone. It goes without saying that the prognosis of the implant is greatly related to the contact rate between the implant body and the bone. With regard to TCP, it is easy to imagine that there will be a large difference in bone contact rate compared to hydroxyapatite, which is currently approved in Japan, considering that the indication site will be replaced by bone. In this study, we apply beta-type TCP to the implant site in order to eliminate the infiltration to the donor site at the bone grafting and reduce the burden on the patient. And the ultimate goal is to get a reliable treatment effect.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes bone volume
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 implant placement
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients wish to have implant treatment at the Department of Oral Implantology, Iwate Medical University Dental Center, and who need bone grafting.
Key exclusion criteria Patients who have systemic illness.
Patients with mental illness
Patients smoking
Patients with abnormal blood test results
Patients with abnormal findings regarding dental treatment
Patients who are uncooperative in research
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Hisatomo
Middle name
Last name Kondo
Organization School of Dentistry, Iwate Medical University
Division name Department of Prosthodontics and Oral Implantology
Zip code 020-8505
Address 19-1 Uchimaru, Morioka, Iwate 020-8505, Japan
TEL 019-651-5111
Email hkondo@iwate-med.ac.jp

Public contact
Name of contact person
1st name Kyoko
Middle name
Last name Takafuji
Organization School of Dentistry, Iwate Medical University
Division name Department of Prosthodontics and Oral Implantology
Zip code 020-8505
Address 19-1 Uchimaru, Morioka, Iwate 020-8505, Japan
TEL 019-651-5111
Homepage URL
Email takafuji@iwate-med.ac.jp

Sponsor
Institute Iwate Medical University
Institute
Department

Funding Source
Organization Iwate Medical 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 Ethics Committee of Iwate Medical University
Address 1-3-27 throughcentral Morioka, Iwate
Tel 019-652-4134
Email shikyomu@j.iwate-med.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
2020 Year 12 Month 25 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled 10
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 No longer recruiting
Date of protocol fixation
2011 Year 08 Month 01 Day
Date of IRB
2011 Year 08 Month 01 Day
Anticipated trial start date
2011 Year 08 Month 01 Day
Last follow-up date
2021 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 12 Month 25 Day
Last modified on
2020 Year 12 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048917

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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