UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059756 |
|---|---|
| Receipt number | R000068179 |
| Scientific Title | Evaluation of the Effectiveness of Oral Hygiene Instruction Using an Intra oral Scanner |
| Date of disclosure of the study information | 2025/11/13 |
| Last modified on | 2025/11/13 12:44:13 |
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Basic information
Public title
Evaluation of the Effectiveness of Oral Hygiene Instruction Using an Intra oral Scanner
Acronym
Evaluation of the Effectiveness of Oral Hygiene Instruction Using an Intra oral Scanner
Scientific Title
Evaluation of the Effectiveness of Oral Hygiene Instruction Using an Intra oral Scanner
Scientific Title:Acronym
Evaluation of the Effectiveness of Oral Hygiene Instruction Using an Intra oral Scanner
Region
| Japan |
Condition
Condition
Periodontal disease
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether using IOS images of disclosed plaque for the Plaque Control Record (PCR) and oral hygiene instruction can improve plaque control.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The reduction rate of the PCR at the follow up visit compared with the PCR obtained from intraoral scanner image records before oral hygiene instruction.
Key secondary outcomes
Comparison of PCR results obtained by visual inspection by dental hygienists and those obtained using intraoral scanner images
Reduction rate of PCR after patients performed oral cleaning by themselves before and after oral hygiene instruction
Comparison of BOP results before oral hygiene instruction and at the follow-up visit
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Oral hygiene instruction using a hand mirror
Interventions/Control_2
Oral hygiene instruction using an intraoral scanner
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients aged 18 years or older and under 90 years at the time of obtaining consent
Patients who have crowns in all of the following regions: maxillary anterior region, maxillary right and left posterior regions, mandibular anterior region, and mandibular right and left posterior regions.
Patients with a most recent PCR of 20% or higher
Patients who perform their own daily oral hygiene without assistance from a caregiver
Patients who have provided their own consent to participate in the study
Key exclusion criteria
Patients with limited finger movement due to conditions such as Parkinson's disease or cerebral infarction
Patients judged to lack decision-making capacity (including those with neuropsychiatric disorders)
Patients deemed inappropriate as study subjects by the principal investigator or co-investigators
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Mika |
| Middle name | |
| Last name | Sato |
Organization
Nagasaki University Hospital
Division name
Dental Hygienist's Office, Department of Medical Technology
Zip code
852-8588
Address
1-7-1 Sakamoto-machi,Nagasaki-shi,Nagasaki-ken,japan
TEL
0958197744
m0520@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Mika |
| Middle name | |
| Last name | Sato |
Organization
Nagasaki University Hospital
Division name
Dental Hygienist's Office, Department of Medical Technology
Zip code
852-8588
Address
1-7-1 Sakamoto-machi,Nagasaki-shi,Nagasaki-ken,japan
TEL
0958197744
Homepage URL
m0520@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
MIKA STO
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
Nagasaki University Hospital
Address
1-7-1 Sakamoto-machi,Nagasaki-shi,Nagasaki-ken,japan
Tel
0958197744
m0520@nagasaki-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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 11 | Month | 13 | 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
| 2025 | Year | 09 | Month | 25 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 19 | Day |
Last follow-up date
| 2027 | Year | 03 | 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
| 2025 | Year | 11 | Month | 13 | Day |
Last modified on
| 2025 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068179
