UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030340
Receipt number R000034648
Scientific Title Evaluating the transition of bacterial composition around dental implants over time
Date of disclosure of the study information 2018/04/01
Last modified on 2021/04/05 21:05:13

* 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

Evaluating the transition of bacterial composition around dental implants over time

Acronym

Transition of bacterial status around dental implants

Scientific Title

Evaluating the transition of bacterial composition around dental implants over time

Scientific Title:Acronym

Transition of bacterial status around dental implants

Region

Japan


Condition

Condition

Missing teeth

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the transition of bacterial composition around dental implants which are placed into patients by submerged insertion and to clarify the factors contributing to such changes.

Basic objectives2

Others

Basic objectives -Others

Unraveling the transition of bacterial composition
Associated factor

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Bacterial composition

Key secondary outcomes

Inflammation of the gums
Plaque
Radiographic assessment


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

1)Subjects with an indication for dental implant treatment who consent to the operation (both maxilla and mandible can be included).
2)Subjects with a first-person voluntary consent to participate in this clinical study, which can be obtained in writing (inpatients, outpatients, or both gender can be included).
3)Subjects aged 20 and above, at the time of a written consent.

Key exclusion criteria

1)The exclusion criteria for study device.
(1)Patients with hemorrhagic diathesis.
(2)Patients with metabolic or endocrine diseases that may significantly affect postoperative bone formation (severe osteoporosis and others).
(3)Patients taking steroids that may affect the postoperative healing of tissues.
(4)Patients with uncontrolled diabetes.
(5)Patients with strong bruxism or in overloading condition.
(6)Patients known to be allergic to the metal (titanium alloy) used in this product.
(7)Patients with a history of radiotherapy at the site of implantation.
(8)Patients for whom postoperative care cannot be controlled such as the following:
- Patients with dementia or other mental disabilities
- Patients with drug addiction
- Patients with alcoholism
(9)Patients with insufficient width and height of bone (bone mass) around the implant (patients who need combination therapy of bone prosthetic materials).
(10)Patients with serious cardiovascular disease such as myocardial infarction.
(11)Pregnant or breast-feeding patients.
(12)Other patients who are not adequate to participate this study.
*Additionally, the exclusion criteria for clinical study.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Shinji
Middle name
Last name Kuroda

Organization

Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University

Division name

Oral Implantology and Regenerative Dental Medicine

Zip code

113-8549

Address

1-5-45, Yushima, Bunkyo-ku, TOKYO , JAPAN

TEL

03-5803-5773

Email

skuroda.mfc@tmd.ac.jp


Public contact

Name of contact person

1st name Masahiro
Middle name
Last name Shimogishi

Organization

Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University

Division name

Oral Implantology and Regenerative Dental Medicine

Zip code

113-8549

Address

1-5-45, Yushima, Bunkyo-ku, TOKYO , JAPAN

TEL

03-5803-5773

Homepage URL


Email

shimogishi.irm@tmd.ac.jp


Sponsor or person

Institute

Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Oral Implantology and Regenerative Dental Medicine

Institute

Department

Personal name



Funding Source

Organization

Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethical Committee of Tokyo Medical and Dental University

Address

1-5-45, Yushima, Bunkyo-ku, TOKYO , 113-8549, JAPAN

Tel

03-5803-5404

Email

d-hyoka.adm@tmd.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

2018 Year 04 Month 01 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

2017 Year 12 Month 12 Day

Date of IRB

2018 Year 02 Month 14 Day

Anticipated trial start date

2018 Year 04 Month 01 Day

Last follow-up date

2025 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

To evaluate the transition of bacterial composition around dental implants and to clarify the factors contributing to such changes.


Management information

Registered date

2017 Year 12 Month 11 Day

Last modified on

2021 Year 04 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034648


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name