UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055077 |
|---|---|
| Receipt number | R000062920 |
| Scientific Title | A study on satisfaction with mechanical tooth cleaning |
| Date of disclosure of the study information | 2024/10/01 |
| Last modified on | 2024/07/25 19:05:48 |
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Basic information
Public title
A study on satisfaction with mechanical tooth cleaning
Acronym
A study on satisfaction with mechanical tooth cleaning
Scientific Title
A study on satisfaction with mechanical tooth cleaning
Scientific Title:Acronym
A study on satisfaction with mechanical tooth cleaning
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Dental medicine | Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We determine the satisfaction by experiencing three types of mechanical tooth cleaning against healthy individuals with natural teeth.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjects' satisfaction after mechanical tooth cleaning using by questionnaire including pain, umconfortable, refresh, treatment time and tongue feeling.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Motor/Tooth surface polishing paste
Interventions/Control_2
Air abrasion (Sodium bicarbonate)
Interventions/Control_3
Air abrasion (Erythritol)
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
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy subjects with natural teeth
Key exclusion criteria
Subjects who did not consent
Subjects with fixed orthodontic appliances
Subjects with sodium intake restrictions
Subjects with respiratory diseases
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | NATSUMI |
| Middle name | |
| Last name | FUJIWARA |
Organization
Tokushima University Graduate School
Division name
Department of Oral Health Care Management
Zip code
770-8504
Address
3-18-15, Kuramoto, Tokushima
TEL
088-633-7963
nfujiwara@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | NATSUMI |
| Middle name | |
| Last name | FUJIWARA |
Organization
Tokushima University Graduate School
Division name
Department of Oral Health Care Management
Zip code
770-8504
Address
3-18-15, Kuramoto, Tokushima
TEL
088-633-7963
Homepage URL
nfujiwara@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University
Institute
Department
Personal name
Natsumi Fujiwara
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokushima University
Address
3-18-15, Kuramoto, Tokushima
Tel
088-633-7963
nfujiwara@tokushima-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
徳島大学歯学部
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 07 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2025 | 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
| 2024 | Year | 07 | Month | 25 | Day |
Last modified on
| 2024 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062920
