UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053543 |
|---|---|
| Receipt number | R000061100 |
| Scientific Title | Investigation of brushing methods to inhibit the increase in the number of bacteria in saliva during brushing |
| Date of disclosure of the study information | 2024/02/05 |
| Last modified on | 2025/08/14 12:18:25 |
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Basic information
Public title
Investigation of brushing methods to inhibit the increase in the number of bacteria in saliva during brushing
Acronym
Investigation of brushing methods to inhibit the increase in the number of bacteria in saliva during brushing
Scientific Title
Investigation of brushing methods to inhibit the increase in the number of bacteria in saliva during brushing
Scientific Title:Acronym
Investigation of brushing methods to inhibit the increase in the number of bacteria in saliva during brushing
Region
| Japan |
Condition
Condition
aspiration pneumonia
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The main cause of aspiration pneumonia is aspiration of saliva-containing bacteria, and the risk of developing the disease increases with the number of bacteria aspirated. Therefore, oral management centered on brushing is widely practiced to reduce the number of bacteria in saliva, but brushing causes plaque to fall into the mouth, which significantly increases the number of bacteria in saliva during brushing. Therefore, brushing methods using water, moisturizing gel, povidone-iodine-containing mouthwash, and povidone-iodine-containing gel are investigated for patients at high risk of aspiration pneumonia, to investigate brushing methods that do not increase the number of bacteria in saliva.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage change in the number of bacteria in saliva before and after each brushing method.
The measurement is not invasive and no follow-up is performed after the measurement.
Key secondary outcomes
Medical record survey items (gender, age, number of remaining teeth, oral wetness, plaque, and dental calculus adhesion)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine | Other |
Interventions/Control_1
Brushing with water on a toothbrush (one time)
Interventions/Control_2
Brushing with moisturizing gel (one time)
Interventions/Control_3
Brushing with povidone-iodine-containing mouthwash (one time)
Interventions/Control_4
Brushing with a mixture of povidone-iodine-containing gel and oral care moisturizer (one time)
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
Subjects with inadequate self-care and capable of self-decision-making
Key exclusion criteria
Persons allergic to iodine.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Madoka |
| Middle name | |
| Last name | Funahara |
Organization
Kyushu Dental University
Division name
Department of Oral Health, Faculty of Dentistry
Zip code
803-8580
Address
2-6-1, Manazuru, 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
Department of Oral Health, Faculty of Dentistry
Zip code
803-8580
Address
2-6-1, Manazuru, Kitakyushu, Fukuoka
TEL
093-285-3109
Homepage URL
r17funahara@fa.kyu-dent.ac.jp
Sponsor or person
Institute
Kyushu Dental University
Institute
Department
Personal name
Funding Source
Organization
None.
Organization
Division
Category of Funding Organization
Self funding
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
| 2024 | Year | 02 | Month | 05 | Day |
Related information
URL releasing protocol
https://www.cureus.com/articles/313793-a-crossover-trial-of-a-novel-toothbrushing-method-for-prevent
Publication of results
Published
Result
URL related to results and publications
https://www.cureus.com/articles/313793-a-crossover-trial-of-a-novel-toothbrushing-method-for-prevent
Number of participants that the trial has enrolled
6
Results
A total of six participants (four males, two females; mean age 51.83 +/- 15.11 years) were enrolled. All required assistance with toothbrushing and were older adults requiring long-term care or individuals needing oral cleaning support. No acute illness was present at enrollment, and daily oral care was provided by caregivers.
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 six participants (four males and two females) were enrolled in this study. The mean age was 51.83 years (+/- 15.11). All participants required assistance with toothbrushing and were either older adults requiring long-term care or individuals in need of support for oral cleaning. No acute illnesses were present at the time of enrollment, and routine oral care was provided daily by caregivers or facility staff prior to the intervention.
Participant flow
Informed consent was obtained, followed by intervention (toothbrushing using water, toothbrushing using a moisturizing agent, and toothbrushing using a mixture of povidone-iodine gel and moisturizing agent), and finally, the procedure was concluded with water rinsing.
Adverse events
none
Outcome measures
Sex, Age, Number of teeth, OHI-DI, Number of bacteria
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2023 | Year | 10 | Month | 19 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 27 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 06 | Day |
Last follow-up date
| 2024 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 02 | Month | 05 | 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=R000061100
