UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043075 |
|---|---|
| Receipt number | R000049154 |
| Scientific Title | Effect of silver fluoride diamine (SDF) application for prevention of plaque adhesion to residual roots of the elderly |
| Date of disclosure of the study information | 2021/02/01 |
| Last modified on | 2021/01/21 14:48:13 |
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Basic information
Public title
Effect of silver fluoride diamine (SDF) application for prevention of plaque adhesion to residual roots of the elderly
Acronym
Effect of silver fluoride diamine (SDF) application for prevention of plaque adhesion to residual roots of the elderly
Scientific Title
Effect of silver fluoride diamine (SDF) application for prevention of plaque adhesion to residual roots of the elderly
Scientific Title:Acronym
Effect of silver fluoride diamine (SDF) application for prevention of plaque adhesion to residual roots of the elderly
Region
| Japan |
Condition
Condition
residual roots
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the effect of SDF application for prevention of plaque adhesion to residual root surface of the elderly.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
One of the residual roots of the subject was classified into the SDF group for performing SDF application, and the remaining one tooth was classified into the control group.The control group was only cleaning. Recording the plaque adhesion status was carried out at the first visit, 2, 4, 6 and 8 weeks in both groups. The residual roots of both groups were photographed from the direction perpendicular to the residual root surface at the first visit, 2, 4, 6 and 8 weeks, then the photographs were sent to image evaluation for plaque adhesion evaluation.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
SDF
Interventions/Control_2
Control
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
| 65 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
have two or more residual root teeth
Key exclusion criteria
Those who cannot go to the hospital continuously
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Yasunori |
| Middle name | |
| Last name | Sumi |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of Advanced Medicine Dentistry and Dental/Oral Surgery
Zip code
474-8511
Address
7-430 Morioka-cho, Obu City, Aichi Prefecture, Japan
TEL
0562-46-5311
nishi.y@ncgg.go.jp
Public contact
Name of contact person
| 1st name | Yu |
| Middle name | |
| Last name | Nakano |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of Advanced Medicine Dentistry and Dental/Oral Surgery
Zip code
474-8511
Address
7-430 Morioka-cho, Obu City, Aichi Prefecture, Japan
TEL
0562-46-5311
Homepage URL
nishi.y@ncgg.go.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
National Center for Geriatrics and Gerontology
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center for Geriatrics and Gerontology
Address
7-430 Morioka-cho, Obu City, Aichi Prefecture, Japan
Tel
0562-46-5311
yaday@ncgg.go.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
国立研究開発法人国立長寿医療研究センター（愛知県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 02 | 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
22
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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 24 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 24 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 30 | 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 | 01 | Month | 21 | Day |
Last modified on
| 2021 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049154
