Unique ID issued by UMIN | UMIN000006407 |
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Receipt number | R000007601 |
Scientific Title | A multi-center randomized controlled clinical trial to examine the clinical, biochemical and antimicrobial effects of a mouth rinse on patients with mild periodontal disease. |
Date of disclosure of the study information | 2011/12/01 |
Last modified on | 2013/10/11 20:14:55 |
A multi-center randomized controlled clinical trial to examine the clinical, biochemical and antimicrobial effects of a mouth rinse on patients with mild periodontal disease.
A multi-center clinical trial to examine the effects of a mouth rinse on patients with mild periodontal disease.
A multi-center randomized controlled clinical trial to examine the clinical, biochemical and antimicrobial effects of a mouth rinse on patients with mild periodontal disease.
A multi-center clinical trial to examine the effects of a mouth rinse on patients with mild periodontal disease.
Japan |
mild periodontal disease
Dental medicine |
Others
NO
The purpose of this multi-center clinical trial is to examine the clinical, biochemical and antimicrobial effects of a mouth rinse containing cetylpyridinium chloride, triclosan and dipotassium glycyrrhizinate on patients with mild periodontal disease.
Efficacy
1. Quigley-Hein plaque index (QHI)
2. Modified gingival index (MGI)
3. Probing pocket depth (PD)
4. Bleeding on probing (BOP)
5. Cytokine levels in gingival crevicular fluid
6. The number of total bacteria and some periodontopathic bacteria in subgingival plaque
Interventional
Parallel
Randomized
Double blind -all involved are blinded
Placebo
2
Treatment
Other |
Test group
First of all, subjects are instructed to brush their teeth as usual twice a day (in the morning and in the evening) with the supplied dentifrice containing sodium fluoride and toothbrush. Then subjects are instructed to rinse with 10 mL of the test mouth rinse for 20 seconds.
Placebo group
First of all, subjects are instructed to brush their teeth as usual twice a day (in the morning and in the evening) with the supplied dentifrice containing sodium fluoride and toothbrush. Then subjects are instructed to rinse with 10 mL of the placebo mouth rinse for 20 seconds.
20 | years-old | <= |
Not applicable |
Male and Female
(1) 20 years old or older persons who obtained written informed consent.
(2) Persons who have good general health with 20 teeth or more.
(3) Persons who have no plan to receive dental treatment during this study period.
(4) Persons who have greater than or equal to 1.5 in QHI (Quigley-Hein Plaque Index) score.
(5) Persons who have greater than or equal to 1.0 and less than 2.3 in MGI (Modified Gingival Index) score.
(1) Persons who took antibiotics and anti-inflammatory agent (except external use) for the past one month prior to this study.
(2) Persons who use a dental floss or an interdental brush daily.
(3) Persons who have the medical history of hypersensitivity to the ingredients (cetylpyridinium chloride, triclosan, dipotassium glycyrrhizinate and others.) containing the mouth rinse.
(4) Persons who are suspected to be diabetic or pregnant.
(5) Persons who have five or more untreated caries lesions (scored C2 and up).
(6) Severe periodontitis patients with tooth mobility or abscess formation.
(7) Persons who are judged to be unqualified for this study subjects by investigators.
90
1st name | |
Middle name | |
Last name | Shinya MURAKAMI |
Osaka University Graduate School of Dentistry
Department of Periodontology, Division of Oral Biology and Disease control
1-8 Yamadaoka, Suita, Osaka, Japan
06-6879-2930
ipshinya@dent.osaka-u.ac.jp
1st name | |
Middle name | |
Last name | Kaori KIMURA |
Osaka University Graduate School of Dentistry
Department of Periodontology, Division of Oral Biology and Disease control
1-8 Yamadaoka, Suita, Osaka, Japan
06-6879-2831
kimura-k@office.osaka-u.ac.jp
Osaka University Graduate School of Dentistry
Sunstar Inc.
Profit organization
Japan
Hiroshima University, Graduate School of Biomedical Sciences, Department of Periodontal Medicine
Aichi-gakuin University, School of Dentistry, Department of Periodontology
Sunstar Inc.
NO
2011 | Year | 12 | Month | 01 | Day |
Unpublished
Completed
2011 | Year | 12 | Month | 01 | Day |
2011 | Year | 12 | Month | 01 | Day |
2011 | Year | 09 | Month | 26 | Day |
2013 | Year | 10 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007601
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