UMIN-CTR Clinical Trial

Public title

Investigation for Growth of Oral Microbes on Pure Titanium Denture Plate

Acronym

Growth of Oral Microbes on Titanium Denture

Scientific Title

Investigation for Growth of Oral Microbes on Pure Titanium Denture Plate

Scientific Title:Acronym

Growth of Oral Microbes on Titanium Denture

Region

Japan

Condition

Normal condition with denture usage

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Investigation for the amount of oral microbes and microbial flora in biofilm formed on pure titanium denture plate

Basic objectives2

Others

Basic objectives -Others

Feeling of usage

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase I

Primary outcomes

ATP activity of oral microbes in the biofilm formed on pure titanium denture plate

Key secondary outcomes

Flora of oral microbes in the biofilm formed on pure titanium denture plate
Feeling of usage

Study type

Interventional

Basic design

Cross-over

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

Usage of pure titanium denture plate

Interventions/Control_2

Usage of Resin denture plate

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

Volunteer who uses either partial denture or complete denture

Key exclusion criteria

Patients who can not be satisfied with denture
Patients who can not keep compliance of the study

Target sample size

10

Name of lead principal investigator

1st name
Middle name
Last name	Shogo Takashiba

Organization

Okayama University

Division name

Department of Pathophysiology - Periodontal Science, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences

Zip code

Address

2-5-1 Shikata-cho, Kita-ku, Okayama, Okayama 700-8525, Japan

TEL

086-235-6675

Email

stakashi@cc.okayama-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Shogo Takashiba

Organization

Okayama University

Division name

Department of Pathophysiology - Periodontal Science, Graduate School of Medicine, Dentistry and Phar

Zip code

Address

2-5-1 Shikata-cho, Kita-ku, Okayama, Okayama 700-8525, Japan

TEL

086-235-6675

Homepage URL

Email

stakashi@cc.okayama-u.ac.jp

Institute

Okayama University

Institute

Department

Personal name

Organization

Ikeda Precision Industrires Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

岡山大学病院

Date of disclosure of the study information

2014

Year

09

Month

29

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

ATP activity of oral microbes in biofilm on denture may be divided to 4 groups according to the ratio of ATP activity on pure titanium plate versus resin plate.
These groups with the ratio (pure titanium plate / resin plate) are shown as followings.
1. Less than 10%: 4 subjects
2. Between 10% and 50%: 3 subjects
4. Between 50 % and 100%: 2 subjects
5. More than 100%: 1 subject
These results suggest that the biofilm formation on pure titanium denture plate seems to be reduced by compared the that on the conventional resin denture plate.

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

2013

Year

10

Month

31

Day

Date of IRB

Anticipated trial start date

2013

Year

11

Month

15

Day

Last follow-up date

2014

Year

05

Month

30

Day

Date of closure to data entry

2014

Year

07

Month

31

Day

Date trial data considered complete

2014

Year

10

Month

31

Day

Date analysis concluded

2014

Year

12

Month

28

Day

Other related information

Questionnaire results are shown as followings.
1. Prefer to pure titanium denture plate: 3 subjects
2. Prefer to resin denture plate: 2 subjects
3. Not prefer either plates: 5 subjects
These results suggest that the feeling of pure titanium denture plate is equivalent to that of conventional resin denture plate. However, when the denture plate was set on the root stump, one subject had strong discomfortable feeling.

When the results for either bacterial amount and feeling of usage were combined, in the cases of 3 subjects who prefer to pure titanium denture plate showed the reduced amount of oral bacteria on the plate less than 10%, whereas in the cases of 2 subjects who prefer to resin denture plate showed the amount of oral bacteria on the plate around 100%.

Registered date

2014

Year

09

Month

29

Day

Last modified on

2016

Year

12

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017769