UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051685 |
|---|---|
| Receipt number | R000058982 |
| Scientific Title | MNC |
| Date of disclosure of the study information | 2023/07/21 |
| Last modified on | 2023/07/21 23:49:46 |
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Basic information
Public title
MNC
Acronym
MNC
Scientific Title
MNC
Scientific Title:Acronym
MNC
Region
| Asia(except Japan) |
Condition
Condition
lack of clarity and definitive uncertainty regarding the impact of switching from tobacco smoking to vape use on the number of buccal and palatal mucosal micronucleus cells.
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
evaluating the effect of vape use on micronucleus cells.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
mnc decrease
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
n-of-1
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
smokers
Interventions/Control_2
smokers switched to vaping
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
smokers
Key exclusion criteria
having an acute illness that required treatment (subjects who had a viral infection) within 4 weeks before the enrolment visit, having oral soft tissue disease or any type of gingival overgrowth other than those caused by plaque, suffering from periodontitis, having a history of tooth loss due to periodontitis, being treated with anticoagulant therapy in the previous six months, using prostheses or orthodontic appliances, history of alcoholism or drug/chemical abuse, taking any drug or substance (other than tobacco) that interferes with the cyclooxygenase pathway (e.g. anti-inflammatory drugs including aspirin and ibuprofen) in the 14 days prior to the enrolment visit, taking antibiotics in the 14 days prior to the enrolment visit, breastfeeding or pregnant women.
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | indra |
| Middle name | mustikasetia |
| Last name | pribadi |
Organization
universitas Padjadjaran
Division name
periodonsia
Zip code
40134
Address
sekeloa selatan no 1 Bandung west java Indonesia
TEL
+628562143662
indra.mustika@unpad.ac.id
Public contact
Name of contact person
| 1st name | Indra |
| Middle name | Mustikasetia |
| Last name | Pribadi |
Organization
Universitas Padjadjaran
Division name
Periodonsia
Zip code
40134
Address
Sekeloa selatan no 1 Bandung west java Indonesia
TEL
+628562143662
Homepage URL
indra.mustika@unpad.ac.id
Sponsor or person
Institute
universitas Padjadjaran
Institute
Department
Personal name
Funding Source
Organization
universitas Padjajdjaran and Smile Study Project
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Universitas Padjadjaran
Address
sekeloa selatan no 1 Bandung West java Indonesia
Tel
+628562143662
indra.mustika@unpad.ac.id
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
| 2023 | Year | 07 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
34
Results
mnc decrease
Results date posted
| 2023 | Year | 07 | Month | 21 | Day |
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
| 2022 | Year | 07 | Month | 10 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 10 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 10 | Day |
Last follow-up date
| 2022 | Year | 12 | 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
| 2023 | Year | 07 | Month | 21 | Day |
Last modified on
| 2023 | Year | 07 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058982
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
