UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022971 |
|---|---|
| Receipt number | 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 14:47:00 |
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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
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
tsudukibashi.osamu@nihon-u.ac.
Sponsor or person
Institute
Nihon University School of Dentistry at Matsudo
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026473
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