UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042854
Receipt number 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 16:31:07

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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 or person

Institute

Iwate Medical University

Institute

Department

Personal name



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

Value
https://center6.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