UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation for Growth of Oral Microbes on Pure Titanium Denture Plate
Title of the study (Brief title)	Growth of Oral Microbes on Titanium Denture
Region	Japan

Condition
Condition	Normal condition with denture usage
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
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

Assessment
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

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
Name of lead principal investigator	Shogo Takashiba
Organization	Okayama University
Division name	Department of Pathophysiology - Periodontal Science, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Address	2-5-1 Shikata-cho, Kita-ku, Okayama, Okayama 700-8525, Japan
TEL	086-235-6675
Email	stakashi@cc.okayama-u.ac.jp

Public contact
Name of contact person	Shogo Takashiba
Organization	Okayama University
Division name	Department of Pathophysiology - Periodontal Science, Graduate School of Medicine, Dentistry and Phar
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

Sponsor
Institute	Okayama University
Institute
Department

Funding Source
Organization	Ikeda Precision Industrires Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	岡山大学病院

Other administrative information
Date of disclosure of the study information	2014 Year 09 Month 29 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 10 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
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.
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%.

Management information
Registered date	2014 Year 09 Month 29 Day
Last modified on	2016 Year 12 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017769