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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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
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
