UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039231 |
|---|---|
| Receipt number | 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 17:35:14 |
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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
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
maristom87@inbox.ru
Sponsor or person
Institute
Sechenov University
Institute
Department
Personal name
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,
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044739
