UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045854 |
|---|---|
| Receipt number | R000052346 |
| Scientific Title | Examining the amount of bacteria in the oral cavity after brushing, wiping, and gargling by real-time PCR method |
| Date of disclosure of the study information | 2021/10/26 |
| Last modified on | 2025/08/14 12:41:47 |
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Basic information
Public title
Examining the amount of bacteria in the oral cavity after brushing, wiping, and gargling by real-time PCR method
Acronym
Examination of the amount of bacteria in the oral cavity after cleaning the oral cavity
Scientific Title
Examining the amount of bacteria in the oral cavity after brushing, wiping, and gargling by real-time PCR method
Scientific Title:Acronym
Examination of the amount of bacteria in the oral cavity after cleaning the oral cavity
Region
| Japan |
Condition
Condition
Healthy individual
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Using the about of bacteria in saliva as an index, examine the effects of oral cleaning and gargling after brushing.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The about of bacteria in the saliva is measured immediately after each method (brushing, cleaning the oral cavity, and gargling with water).
The measurement is not invasive and no follow-up is performed after the measurement.
Key secondary outcomes
Medical record survey items (gender, age, medical history, medication status, BMI, number of remaining teeth, presence or absence of mouth breathing, smoking, drinking, oral wetness, plaque, and dental calculus adhesion)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Brushing, cleaning the oral cavity, and gargling with water are performed on healthy subjects.
Interventions/Control_2
Brushing, cleaning the oral cavity, and cleaning the oral cavity with a sponge brush.
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Can be gargled
Key exclusion criteria
Cannot contain gargle
Under 20 years old
Oral cancer patients
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Madoka |
| Middle name | |
| Last name | Funahara |
Organization
Kyushu Dental University
Division name
School of Oral Health Sciences, Faculty of Dentistry
Zip code
803-8580
Address
2-6-1 Manazuru, 231 Kokurakitaku, Kitakyushu Fukuoka
TEL
093-285-3109
r17funahara@fa.kyu-dent.ac.jp
Public contact
Name of contact person
| 1st name | Madoka |
| Middle name | |
| Last name | Funahara |
Organization
Kyusyu Dental University
Division name
School of Oral Health Sciences, Faculty of Dentistry
Zip code
803-8580
Address
2-6-1 Manazuru, 231 Kokurakitaku, Kitakyushu Fukuoka
TEL
093-285-3109
Homepage URL
r17funahara@fa.kyu-dent.ac.jp
Sponsor or person
Institute
School of Oral Health Sciences Kyushu Dental University
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee, Kyushu Dental University
Address
2-6-1, Manazuru, Kitakyushu, Japan
Tel
093-285-3011
kyoumu@kyu-dent.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
| 2021 | Year | 10 | Month | 26 | Day |
Related information
URL releasing protocol
https://bmcoralhealth.biomedcentral.com/articles/10.1186/s12903-023-03676-7
Publication of results
Published
Result
URL related to results and publications
https://bmcoralhealth.biomedcentral.com/articles/10.1186/s12903-023-03676-7
Number of participants that the trial has enrolled
40
Results
In 40 dental outpatients, salivary bacterial counts were higher in those with poorer oral hygiene and fewer teeth. Brushing increased counts; wiping did not reduce them, while mouthwashing restored counts to pre-brushing levels.
Results date posted
| 2025 | Year | 08 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 40 dental outpatients (17 males, 23 females; mean age 70.83 +/- 14.09 years) participated. All underwent toothbrushing for oral cleaning, followed by either mouthwashing or oral wiping using a sponge brush.
Participant flow
Forty dental outpatients were enrolled. All underwent toothbrushing for oral cleaning and were randomly assigned to mouthwashing or oral wiping using a sponge brush. All completed the intervention and saliva sampling, and were included in the analysis.
Adverse events
none
Outcome measures
Change in total salivary bacterial count before and after toothbrushing, and after mouthwashing or oral wiping, measured by real-time PCR.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2021 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 12 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 13 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | 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 | 10 | Month | 25 | Day |
Last modified on
| 2025 | Year | 08 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052346
