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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022971
Receipt No. R000026473
Scientific Title Antibacterial effect on periodontopathic bacteria by manicure of the tooth which contained antibacterial
Date of disclosure of the study information 2016/07/04
Last modified on 2019/11/25

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Basic information
Public title Antibacterial effect on periodontopathic bacteria by manicure of the tooth which contained antibacterial
Acronym Antibacterial effect on manicure of the tooth
Scientific Title Antibacterial effect on periodontopathic bacteria by manicure of the tooth which contained antibacterial
Scientific Title:Acronym Antibacterial effect on manicure of the tooth
Region
Japan

Condition
Condition Periodontal disease
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to investigate whether manicure of the tooth (HANIC DCpro EX: Hanic White Labo Co., Ltd.) has an antibacterial effect on periodontal disease original bacteria on not. In our vitro experiment, the abietic acid included in this product showed a high antibacterial effect on Porphyromonas gingivalis (P.gingivalis) which is one of bacteria group most related to periodontal disease.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes Ten subjects who possess Porphyromonas gingivalis carry out toothbrushing after breakfast and lunch as usual and apply this manicure by subject oneself according to an instruction manual each time. The first samples are collected right before the subjects apply this manicure. After they apply it consecutively for ten days, the second sample is collected on the eleventh day. By the qPCR method, determining the quantity of P. gingivalis in those samples are performed in order to investigate whether this product has an antibacterial effect on P. gingivalis.
Key secondary outcomes Gingival crevicular fluid samples from the subjects who consented For this study are collected using sterile paper points. After DNA extraction in the samples, having P.gingivalis or not is examined by the PCR method, and ten subjects are selected for this study.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 The subjects who do not possess gingivalis are excluded at this point in time.
Interventions/Control_2 Ten subjects who possess Porphyromonas gingivalis carry out toothbrushing after breakfast and lunch as usual and apply this manicure by subject oneself according to an instruction manual each time. The first samples are collected right before the subjects apply this manicure. After they apply it consecutively for ten days, the second sample is collected on the eleventh day. By the qPCR method, determining the quantity of P. gingivalis in those samples are performed in order to investigate whether this product has an antibacterial effect on P. gingivalis.
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
30 years-old <=
Age-upper limit
70 years-old >=
Gender Male and Female
Key inclusion criteria Because this study is intended for the adults with periodontal disease, the physically healthy person from 30 to 70 years old
Key exclusion criteria Pregnant women, the person with the dosage of antibiotics within the past six months, the person with diabetes, the person with stomatitism, and the person with alcohol allergy
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Osamu
Middle name
Last name Tsuzukibashi
Organization Nihon University School of Dentistry at Matsudo
Division name Department of Microbiology and Immunology
Zip code 271-8587
Address 870-1, Sakaecho Nishi-2, Matsudo, Chiba
TEL 047-360-9341
Email tsudukibashi.osamu@nihon-u.ac.jp

Public contact
Name of contact person
1st name Osamu
Middle name
Last name Tsuzukibashi
Organization Nihon University School of Dentistry at Matsudo
Division name Department of Microbiology and Immunology
Zip code 271-8587
Address 870-1, Sakaecho Nishi-2, Matsudo, Chiba
TEL 047-360-9341
Homepage URL
Email tsudukibashi.osamu@nihon-u.ac.

Sponsor
Institute Nihon University School of Dentistry at Matsudo
Institute
Department

Funding Source
Organization Nihon University School of Dentistry at Matsudo
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 Nihon University School of Dentistry at Matsudo
Address 870-1, Sakaecho Nishi-2, Matsudo, Chiba
Tel 047-360-9341
Email tsudukibashi.osamu@nihon-u.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
2016 Year 07 Month 04 Day

Related information
URL releasing protocol https://upload.umin.ac.jp/cgi-bin/ctr/ctr_menu_form_reg.cgi?recptno=R000026473
Publication of results Unpublished

Result
URL related to results and publications https://upload.umin.ac.jp/cgi-bin/ctr/ctr_menu_form_reg.cgi?recptno=R000026473
Number of participants that the trial has enrolled 5
Results
As a result of having applied HANIC DCpro EX for ten days, Tannerella forsythia which was Red complex bacteria significantly decreased after HANIC DCpro EX application (P<0.05). Number of the total bacteria (P=0.072), Porphyromonas gingivalis (P=0.068) and Treponema denticola (P=0.08) showed a tendency to decrease after HANIC DCpro EX application, but there was not the significant difference.
Results date posted
2019 Year 11 Month 25 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 8 patients were eligible for participation in this study. 3 were excluded according to the exclusion criteria and 5 were assigned.
Participant flow
 After a 1-week washout period, subjects were crossed over to receive the other treatment. All treatments were performed over the same time span.
 
Adverse events
nothing
Outcome measures
As a result of having applied HANIC DCpro EX for ten days, Tannerella forsythia which was Red complex bacteria significantly decreased after HANIC DCpro EX application (P<0.05). Number of the total bacteria (P=0.072), Porphyromonas gingivalis (P=0.068) and Treponema denticola (P=0.08) showed a tendency to decrease after HANIC DCpro EX application, but there was not the significant difference. On the other hand, as a result of having applied the placebo manicure for ten days, there was not the significant difference between the numbers of the total bacteria, Porphyromonas gingivalis, Tannerella forsythia and Treponema denticola before and after the manicure application.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 07 Month 30 Day
Date of IRB
2016 Year 05 Month 24 Day
Anticipated trial start date
2016 Year 08 Month 01 Day
Last follow-up date
2017 Year 07 Month 03 Day
Date of closure to data entry
2017 Year 07 Month 03 Day
Date trial data considered complete
2017 Year 07 Month 03 Day
Date analysis concluded
2017 Year 07 Month 03 Day

Other
Other related information

Management information
Registered date
2016 Year 07 Month 01 Day
Last modified on
2019 Year 11 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026473

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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