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 |
Antibacterial effect on periodontopathic bacteria by manicure of the tooth which contained antibacterial
Antibacterial effect on manicure of the tooth
Antibacterial effect on periodontopathic bacteria by manicure of the tooth which contained antibacterial
Antibacterial effect on manicure of the tooth
Japan |
Periodontal disease
Dental medicine |
Others
NO
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.
Efficacy
Confirmatory
Pragmatic
Phase I
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.
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.
Interventional
Parallel
Randomized
Cluster
Open -no one is blinded
No treatment
NO
YES
Institution is not considered as adjustment factor.
NO
No need to know
2
Prevention
Other |
The subjects who do not possess gingivalis are excluded at this point in time.
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.
30 | years-old | <= |
70 | years-old | >= |
Male and Female
Because this study is intended for the adults with periodontal disease, the physically healthy person from 30 to 70 years old
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
100
1st name | Osamu |
Middle name | |
Last name | Tsuzukibashi |
Nihon University School of Dentistry at Matsudo
Department of Microbiology and Immunology
271-8587
870-1, Sakaecho Nishi-2, Matsudo, Chiba
047-360-9341
tsudukibashi.osamu@nihon-u.ac.jp
1st name | Osamu |
Middle name | |
Last name | Tsuzukibashi |
Nihon University School of Dentistry at Matsudo
Department of Microbiology and Immunology
271-8587
870-1, Sakaecho Nishi-2, Matsudo, Chiba
047-360-9341
tsudukibashi.osamu@nihon-u.ac.
Nihon University School of Dentistry at Matsudo
Nihon University School of Dentistry at Matsudo
Other
Nihon University School of Dentistry at Matsudo
870-1, Sakaecho Nishi-2, Matsudo, Chiba
047-360-9341
tsudukibashi.osamu@nihon-u.ac.jp
NO
2016 | Year | 07 | Month | 04 | Day |
https://upload.umin.ac.jp/cgi-bin/ctr/ctr_menu_form_reg.cgi?recptno=R000026473
Unpublished
https://upload.umin.ac.jp/cgi-bin/ctr/ctr_menu_form_reg.cgi?recptno=R000026473
5
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.
2019 | Year | 11 | Month | 25 | Day |
A total of 8 patients were eligible for participation in this study. 3 were excluded according to the exclusion criteria and 5 were assigned.
After a 1-week washout period, subjects were crossed over to receive the other treatment. All treatments were performed over the same time span.
nothing
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.
Completed
2016 | Year | 07 | Month | 30 | Day |
2016 | Year | 05 | Month | 24 | Day |
2016 | Year | 08 | Month | 01 | Day |
2017 | Year | 07 | Month | 03 | Day |
2017 | Year | 07 | Month | 03 | Day |
2017 | Year | 07 | Month | 03 | Day |
2017 | Year | 07 | Month | 03 | Day |
2016 | Year | 07 | Month | 01 | Day |
2019 | Year | 11 | Month | 25 | Day |
Value
https://center6.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 |