UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000039231
Receipt No. R000044739
Scientific Title Qualitative and quantitative assessment of remineralizing effect of prophylactic toothpaste promoting brushite formation: a randomized clinical trial
Date of disclosure of the study information 2020/07/01
Last modified on 2020/01/22

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Assessment of the remineralizing effect of a toothpaste promoting the formation of tooth minerals
Acronym Remineralizing effect of a brushite toothpaste
Scientific Title Qualitative and quantitative assessment of remineralizing effect of prophylactic toothpaste promoting brushite formation: a randomized clinical trial
Scientific Title:Acronym Assessment of remineralizing effect of prophylactic toothpaste promoting brushite formation
Region
Europe

Condition
Condition Tooth hypersensitivity
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the effect of brushite and hydroxiapatite on hypersensitivity, enamel acid resistance, and its speed of remineralization.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Decrease in teeth hypersensitivity
Key secondary outcomes Increase in enamel acid resistance and speed of its remineralization

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 toothpaste promoting the formation of brushite
Interventions/Control_2 toothpaste with hydroxyapatite
Interventions/Control_3 toothpaste without remineralising components
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
20 years-old <=
Age-upper limit
25 years-old >=
Gender Male and Female
Key inclusion criteria Patients with enamel hypersensitivity
Key exclusion criteria The presence of orthodontic appliance, malocclusion, allergic reactions to the components of toothpastes, systemic diseases, pregnancy.
Target sample size 54

Research contact person
Name of lead principal investigator
1st name Maria
Middle name
Last name Polyakova
Organization Sechenov University
Division name Department of therapeutic dentistry
Zip code 121059
Address Mojaiskii val, Moscow, Russia
TEL +79057980386
Email mafka-03@mail.ru

Public contact
Name of contact person
1st name Marianna
Middle name
Last name Arakelyan
Organization Sechenov University
Division name Department of therapeutic dentistry
Zip code 121059
Address Mojaiskii val, Moscow, Russia
TEL +79265487557
Homepage URL
Email maristom87@inbox.ru

Sponsor
Institute Sechenov University
Institute
Department

Funding Source
Organization Supported by the "Russian Academic Exellence Project 5-100
Organization
Division
Category of Funding Organization Outside Japan
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Sechenov University
Address Trubetskaya str, 8, Moscow, Russia, 119991
Tel +7(495)622-97-06; +7(495)622-97-56,
Email iec@1msmu.ru, iec@sechenov.ru

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 Dental Center, Sechenov University, Department of the Therapeutic dentistry

Other administrative information
Date of disclosure of the study information
2020 Year 07 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 60
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 Completed
Date of protocol fixation
2018 Year 12 Month 05 Day
Date of IRB
2018 Year 12 Month 05 Day
Anticipated trial start date
2019 Year 03 Month 01 Day
Last follow-up date
2019 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 01 Month 22 Day
Last modified on
2020 Year 01 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044739

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.