UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043228 |
|---|---|
| Receipt number | R000049278 |
| Scientific Title | Confirmation trial about clinical/preventive effects of newly developed toothpaste against periodontal disease |
| Date of disclosure of the study information | 2022/02/07 |
| Last modified on | 2021/07/27 10:47:53 |
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Basic information
Public title
Confirmation trial about clinical/preventive effects of newly developed toothpaste against periodontal disease
Acronym
Confirmation trial about clinical/preventive effects of newly developed toothpaste against periodontal disease
Scientific Title
Confirmation trial about clinical/preventive effects of newly developed toothpaste against periodontal disease
Scientific Title:Acronym
Confirmation trial about clinical/preventive effects of newly developed toothpaste against periodontal disease
Region
| Japan |
Condition
Condition
Healthy male/female volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to evaluate periodontosis-inhibitory effects by test-product usage for 4 weeks
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Gingivitis index
2. Dental plaque index
3. Depth of periodontal pocket
Key secondary outcomes
1. Swelling
2. Reddening
3. Existence quantification of P. gingivalis / T. forsythia in saliva
4. Free Hb value / LDH activity in saliva
5. Overall effectiveness
6. Concentrations of volatile sulfur compounds, just like H2S and Me3SH
7. IL-1beta / IL-8 activity in saliva
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Continuous application of the toothpaste to the volunteers every daily meal for 4 weeks.
Interventions/Control_2
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
| 35 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Healthy male/female volunteers ranging in age from 35 to 64 years old.
(2) Volunteers having mild-to-moderate gingivitis.
(3) According to the clinical observation, volunteers having not less than one periodontal pocket with not less than 4 mm.
(4) At the screening test, volunteers who were determined as a patient having not less than one tooth equipped with level-1 or 2 on the GI index.
(5) Volunteers having no scaling about the observation region within the last three months to the current trial.
(6) Volunteers having meals three times a day, and toothbrushing after each meal.
(7) Volunteers having not less than four teeth among measurable six ones (FDI: 16, 12, 24, 36, 32, 44), or their alternatives (FDI: 17, 15, 11, 25, 37, 35, 31, 45).
(8) Volunteers equipped with not less than 20 teeth, and without some kind of periodontal disease.
(9) Volunteers who gave informed consent to take part in this trial after being provided with an explanation of the protocol detail.
Key exclusion criteria
(1) At the screening test, volunteers who were determined as a patient having some dental caries (over C3 level) and/or severe periodontal disease.
(2) Volunteers with medical treatment for diabetic, chronic kidney, digestive, lung or cancer diseases.
(3) Volunteers having some kind of systemic disease, which has serious difficulty in participating this trial.
(4) Volunteers with toothbrushing not less than four times a day, including the brushing before and after breakfast, before their normal bedtime, etc.
(5) Pregnant, possibly pregnant, or lactating women, during this clinical trial.
(6) Volunteers who are now under the other clinical trials with some kind of medicine/food, or willing to participate in similar tests.
(7) Volunteers having their stimulating saliva with no more than 3.0 mL for 5 min.
(8) Volunteers having stimulating saliva with no more than a pH of 6.2.
(9) Volunteers with some kind of allergy.
(10) Volunteers equipped with removable denture, and/or dental implant on the dental object.
(11) Volunteers falling into the habit of smoking.
(12) Volunteers who have regularly used some kind of health food.
(13) Volunteers who have took in some kind of antibiotic and/or antibacterial agent, regularly or within the last month to the screening test.
(14) Others who have been determined as ineligible for participation, judging from the principal/sub investigator's opinions.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tomohiko |
| Middle name | |
| Last name | Yamaguchi |
Organization
DAIICHI SANKYO HEALTHCARE CO., LTD
Division name
Chief Director
Zip code
140-8710
Address
3-14-10 Nihonbashi, Chuo-ku, Tokyo 140-8710, Japan
TEL
03-5225-6330
yamaguchi.tomohiko.m6@daiichisankyo-hc.co.jp
Public contact
Name of contact person
| 1st name | Eiji |
| Middle name | |
| Last name | Yoshikawa |
Organization
KSO Corporation
Division name
Sales department
Zip code
105-0023
Address
7F Shibaura-Omodaka Building, 1-9-7 Shibaura, Minato-ku, Tokyo 105-0023, Japan
TEL
03-3452-7733
Homepage URL
yoshikawa@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
Funding Source
Organization
DAIICHI SANKYO HEALTHCARE CO., LTD
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee of Nihonbashi Cardiology Clinic
Address
Kyodo Building, 13-4-201 Nihonbashi-Kodenma-Cho, Chuo-ku, Tokyo 103-0001, Japan
Tel
03-5641-4133
niho-jimucho@well-sleep.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
| 2022 | Year | 02 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 11 | Month | 26 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 18 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 07 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 02 | Month | 02 | Day |
Last modified on
| 2021 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049278
