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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000037610
Receipt No. R000042866
Scientific Title Evaluation of S-PRG filler function as an abrasive.
Date of disclosure of the study information 2019/10/01
Last modified on 2019/08/08

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Basic information
Public title Evaluation of S-PRG filler function as an abrasive.
Acronym Evaluation of S-PRG filler function as an abrasive.
Scientific Title Evaluation of S-PRG filler function as an abrasive.
Scientific Title:Acronym Evaluation of S-PRG filler function as an abrasive.
Region
Japan

Condition
Condition caries
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of function as an abrasive.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The tooth surface is not brushed for 48 hours, and after plaque is attached, the dentist performs mechanical tooth surface cleaning, and then the residual rate of plaque is evaluated by the staining solution. Do not perform tooth surface cleaning for another 48 hours. After 48 hours, the dentist assesses the rate of plaque reattachment using a staining solution.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 The plaque removal and reattachment rates were assessed by tooth surface cleaning using a PRG Procare Gel(26B1X00004000230).
Interventions/Control_2 The plaque removal and reattachment rates were assessed by tooth surface cleaning using a control Gel.
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
22 years-old <=
Age-upper limit
35 years-old >=
Gender Male and Female
Key inclusion criteria Dentists enrolled in pediatric dentistry at Tohoku University are the subjects.
1.Cleaning of tooth surface is possible.
2.Consent can be obtained in writing from the research subject.
Key exclusion criteria 1. having malocclusion or caries or a crown prosthesis.
2. Dentists judged to be inappropriate by the attending physician.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name satoshi
Middle name
Last name Fukumoto
Organization Tohoku Univ.
Division name Pediatric Dent.
Zip code 980-8575
Address 4-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi,
TEL 022-717-8382
Email fukumoto@dent.tohoku.ac.jp

Public contact
Name of contact person
1st name Kan
Middle name
Last name Saito
Organization Tohoku Univ.
Division name Pediatric Dent.
Zip code 980-8575
Address 4-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi,
TEL 022-717-8382
Homepage URL
Email kan.saito.b1@tohoku.ac.jp

Sponsor
Institute Tohoku Univ.
Institute
Department

Funding Source
Organization Tohoku Univ.
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 Tohoku University Graduate School of Dentistry
Address 4-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi,
Tel 022-717-8244
Email rinri-esct@proj.med.tohoku.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
2019 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 No longer recruiting
Date of protocol fixation
2019 Year 04 Month 01 Day
Date of IRB
2019 Year 09 Month 25 Day
Anticipated trial start date
2019 Year 10 Month 01 Day
Last follow-up date
2020 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
2019 Year 08 Month 06 Day
Last modified on
2019 Year 08 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042866

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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