UMIN-CTR Clinical Trial

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

missing tooth

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

bone volume

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Iwate Medical University

Institute

Department

Personal name

Organization

Iwate Medical University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2020

Year

12

Month

25

Day

URL releasing protocol

Publication of results

Partially published

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

Recruitment status

Completed

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 related information

Registered date

2020

Year

12

Month

25

Day

Last modified on

2024

Year

06

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048917