UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044214
Receipt number 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 2022/11/24 07:42:38

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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 or person

Institute

Dental Faculty - Universitas Padjadjaran
Periodontology

Institute

Department

Personal name



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

Value
https://center6.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