UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037381 |
|---|---|
| Receipt number | R000042611 |
| Scientific Title | Clinical parameters and bacteriological evaluation of periodontal therapeutic toothpaste |
| Date of disclosure of the study information | 2019/07/15 |
| Last modified on | 2024/01/17 16:26:42 |
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Basic information
Public title
Examination of clinical effect of acess on patients with periodontal disease
Acronym
Examination of the clinical effect of Acess
Scientific Title
Clinical parameters and bacteriological evaluation of periodontal therapeutic toothpaste
Scientific Title:Acronym
Clinical parameters and bacteriological evaluation of periodontal therapeutic toothpaste
Region
| Japan |
Condition
Condition
choronic periodontitis
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of the clinical parameters in the case of the use of Acess at the time of brushing, and to investigate the effects on oral bacteria, including periodontal pathogenic bacteria.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amounts of bacteria
time of assesment at the start of the study, 2 weeks and 4 weeks after the start of the study
Key secondary outcomes
periodontal pocket depth,GI,BOP
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Acess
2 time/day, 1month
Interventions/Control_2
brushing
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Age 20 years old or older
The residual teeth more than 15 teeth
Periodontal pocket 4mm
Key exclusion criteria
Person with a serious systemic disease
Person who dentist judged in adequate
Target sample size
68
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Gomi |
Organization
Tsurumi University, School of Dental Medicine
Division name
Department of Periodontology
Zip code
230-8501
Address
2-1-3,Tsurumi, Tsurumi-ku, Yokohama
TEL
045-580-8431
gomi-k@tsurumi-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Shirakawa |
Organization
Tsurumi University,School of Dental Medicine
Division name
Department of Periodontology
Zip code
230-8501
Address
2-1-3 Tsurumi, Tsurumi-ku,Yokohama
TEL
045-580-8433
Homepage URL
shirakawa-satoshi@tsurumi-u.ac.jp
Sponsor or person
Institute
Department of Periodontology, School of Dental Medicine, Tsurumi University
Institute
Department
Personal name
Funding Source
Organization
Sato Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tsurumi University Education Research Support Center Administrative Division Education Research Support Division
Address
2-1-3 Tsurumi, Tsurumi-ku, yokohama
Tel
045-580-8318
rinrishinsa@tsurumi-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
鶴見大学歯学部附属病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 07 | Month | 15 | 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
| Delay expected |
Results Delay Reason
under submission
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
| 2016 | Year | 05 | Month | 11 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 11 | Day |
Anticipated trial start date
| 2016 | Year | 05 | Month | 11 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2020 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2020 | Year | 04 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 07 | Month | 15 | Day |
Last modified on
| 2024 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042611
