UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037610 |
|---|---|
| Receipt number | 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 14:18:18 |
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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
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
kan.saito.b1@tohoku.ac.jp
Sponsor or person
Institute
Tohoku Univ.
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
