UMIN-CTR Clinical Trial

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	none
Publication of results	Unpublished

Result
URL related to results and publications	none
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	18 to 45 yo no systemic conditions not being pregnant not giving breastfeeding no restorations or crown no carious lesions
Participant flow	D(-7) dental prophylaxis, oral hygiene instrusction, D1 until D21 : experimental gingivitis, abstaining from dental cleaning D14 and D21 : data collection D22 : professional dental cleaning and reassume daily tooth cleaning
Adverse events	None reported
Outcome measures	Plaque accumulation, Gingival inflammation, Gingival bleeding and salivary nicotine
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
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	2022 Year 11 Month 24 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000050489