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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000044214
Receipt No. R000050489
Scientific Title Gingival Inflammation and Hemorrhagic Responsiveness in Vapers during Experimental Gingivitis
Date of disclosure of the study information 2021/05/30
Last modified on 2021/05/15

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Basic information
Public title Gingival Response in Vapers during Experimental Gingivitis
Acronym Experimental Gingivitis in Vapers
Scientific Title Gingival Inflammation and Hemorrhagic Responsiveness in Vapers during Experimental Gingivitis
Scientific Title:Acronym Gingival Inflammation and Hemorrhagic Responsiveness in Vapers during Experimental Gingivitis : Experimental Gingivitis in Vapers
Region
Asia(except Japan)

Condition
Condition Healthy adult, with only mild gingivitis
Classification by specialty
Dental medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To study the gingival response in vapers during experimental gingivitis compared to those of smokers and non-smokers
Basic objectives2 Others
Basic objectives -Others to confirm the cotinine level in saliva of vapers
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes gingival index and angulated bleeding index
Key secondary outcomes salivary cotinine levels

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 dental prophylaxis at baseline and day 21,
experimental gingivitis for 21 days only in lower jaw.
Interventions/Control_2 dental prophylaxis at baseline and day 21,
experimental gingivitis for 21 days only in lower jaw.
Interventions/Control_3 dental prophylaxis at baseline and day 21,
experimental gingivitis for 21 days only in lower jaw.
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
55 years-old >
Gender Male and Female
Key inclusion criteria 1. Male or female,
2. Smoker is an individual who has been smoking tobacco cigarette/combustible cigarette for at least 1 year,
3. Vaper is an individual who has been vaping with nicotine-contained liquid for at least 1 year,
4. Non-smoker is an individual who never smokes nor vapes
5. Pocket depth less than 4 mm
6. Voluntary to participate and signing informed consent
Key exclusion criteria 1. Dual user of tobacco/combustible cigarette and vape
2. Having prostheses, fixed orthodontic appliances and cervical tooth decay in lower jaw
3. Taking medications such as antibiotics, steroid or NSAID, 6 months prior to the study,
4. Having systemic conditions such as diabetes mellitus, hepatitis, HIV, TBC, CVD or kidney disorder,
5. Being pregnant or lactating,
6. Having periodontitis

Target sample size 15

Research contact person
Name of lead principal investigator
1st name Amaliya
Middle name
Last name Amaliya
Organization Dental Faculty Universitas Padjadjaran, Bandung, Indonesia
Division name Periodontology
Zip code 40132
Address Jalan Sekeloa Selatan no 1 Bandung
TEL 0062222504985
Email amaliya@fkg.unpad.ac.id

Public contact
Name of contact person
1st name Amaliya
Middle name
Last name Amaliya
Organization Dental Faculty Universitas Padjadjaran, Bandung, Indonesia
Division name Periodontology
Zip code 40132
Address Jalan Sekeloa Selatan no 1 Bandung
TEL 0062222504985
Homepage URL
Email amaliya@fkg.unpad.ac.id

Sponsor
Institute Dental Faculty - Universitas Padjadjaran
Periodontology
Institute
Department

Funding Source
Organization Dental Faculty Universitas Padjadjaran
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Indonesia

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

IRB Contact (For public release)
Organization Ethical Commitee Faculty of Medicine Universitas Padjadjaran
Address Jalan Prof Eijkman no 38 Bandung
Tel 0062222038697
Email etik.unpad@gmail.com

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 Hospital Universitas Padjadjaran Bandung - West Java, Indonesia

Other administrative information
Date of disclosure of the study information
2021 Year 05 Month 30 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 15
Results In spite of similar plaque accumulation, smokers displayed less gingival responses and bleeding upon provocation, whereas vapers showed gingival response similar to those of non-smokers in the presence of nicotine/salivary cotinine
Results date posted
2021 Year 05 Month 15 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events None reported
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2020 Year 09 Month 20 Day
Date of IRB
2020 Year 10 Month 14 Day
Anticipated trial start date
2021 Year 01 Month 04 Day
Last follow-up date
2021 Year 03 Month 10 Day
Date of closure to data entry
2021 Year 04 Month 01 Day
Date trial data considered complete
2021 Year 05 Month 05 Day
Date analysis concluded
2021 Year 05 Month 10 Day

Other
Other related information

Management information
Registered date
2021 Year 05 Month 15 Day
Last modified on
2021 Year 05 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050489

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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