UMIN-CTR Clinical Trial

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
Email	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
Email	nishi.y@ncgg.go.jp

Sponsor
Institute	National Center for Geriatrics and Gerontology
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049154