UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056524 |
|---|---|
| Receipt number | R000064589 |
| Scientific Title | Evaluating the Effect of Switching from Tobacco Cigarettes to Combustion-Free Nicotine Delivery Systems on Gingiva, a Randomized-Controlled Trial |
| Date of disclosure of the study information | 2024/12/20 |
| Last modified on | 2024/12/20 17:11:38 |
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Basic information
Public title
Clinical and Biomolecular Study Evaluating The Effect of Switching from Tobacco Cigarettes to Combustion-Free Nicotine Delivery Systems on Gingiva, A Randomized-Controlled Trial
Acronym
The Effect of Switching from Tobacco Cigarettes to Combustion-Free Nicotine Delivery Systems on Gingiva, A Randomized-Controlled Trial
Scientific Title
Evaluating the Effect of Switching from Tobacco Cigarettes to Combustion-Free Nicotine Delivery Systems on Gingiva, a Randomized-Controlled Trial
Scientific Title:Acronym
Effect of Switching from Tobacco Cigarettes to CF-NDS on Gingiva
Region
| Asia(except Japan) |
Condition
Condition
Systematically and periodontally healthy subjects, with a maximum of slight periodontitis
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of switching from tobacco cigarettes to Combustion-Free Nicotine Delivery Systems (C-F NDS) by clinical and biomolecular studies on gingiva
Basic objectives2
Others
Basic objectives -Others
To evaluate the response of gingiva in smokers switching to C-F NDS
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
To evaluate the change in clinical parameters and biomarkers in gingiva and saliva after switching from tobacco cigarettes to C-F NDS
Key secondary outcomes
To evaluate the change in bacterial LPS and olfa-gustatory perceptions
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Intervention Group : The subject has to quit smoking tobacco cigarettes and will be given C-FNDS for 3 months
Interventions/Control_2
Control Group: The subject continues the smoking habit without any interventions
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
| 21 | years-old | <= |
Age-upper limit
| 55 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. The subject understands the purpose of the study and gives informed consent
2. Healthy, no medication for chronic diseases
3. Must be 21 yrs old or more at the time of screening
4. Having at least 10 teeth at each jaw including 6 anterior teeth
5. Periodontally healthy or at maximum suffers from slight periodontitis
6. Smoking combustible cigarette products, more than 10 cigarettes per day, for at least 5 years at the time of screening
7. Exhaled CO level of >= 7 ppm at the time of screening
8. Willing to switch from combustion cigarettes to C-F NDS if allocated to the experimental group or continue to smoke their cigarette if assigned to the control group
9. Willing to comply with all study procedures.
Key exclusion criteria
1. Being pregnant
2. Willing to quit smoking at the time of screening
3. Having cervical caries/dental decay,
4. Having pathologic conditions in oral soft tissue including gingival enlargement instead of plaque-induced gingivitis
5. Having moderate or severe periodontitis with CAL > 3 mm and periodontal pocket depth of > 3 mm at more than 2 teeth
6. Having orthodontic treatment or prosthesis, fixed or removable appliances
7. History of alcoholism or drug abuse
8. Having treated with any medications that affect the cyclooxygenase pathway or anti-inflammation within 3 days before each study visit
9. Having treated with antibiotics within 7 days before each study visit.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Amaliya |
| Middle name | |
| Last name | Amaliya |
Organization
Dental Faculty, Universitas Padjadjaran, Bandung - West Java, INDONESIA
Division name
Periodontology
Zip code
40132
Address
Jalan Sekeloa Selatan no. 1
TEL
0062222504985
amaliya@unpad.ac.id
Public contact
Name of contact person
| 1st name | Amaliya |
| Middle name | |
| Last name | Amaliya |
Organization
Dental Faculty, Universitas Padjadjaran, Bandung - West Java, INDONESIA
Division name
Periodontology
Zip code
40132
Address
Jalan Sekeloa Selatan no. 1
TEL
0062222504985
Homepage URL
https://fkg.unpad.ac.id/
amaliya@unpad.ac.id
Sponsor or person
Institute
Dental Faculty, Universitas Padjadjaran, Bandung - West Java - INDONESIA
Institute
Department
Personal name
Amaliya Amaliya
Funding Source
Organization
Universitas Padjadjaran
Grant for Doctoral Program Research
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Indonesia
Other related organizations
Co-sponsor
KABAR (Koalisi Indonesia Bebas Tar) = Indonesian Coalition of Tar-Free
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ladokgi Ethical Commitee
Address
Jalan Farmasi no 1 Bendungan Hilir, Jakarta, Indonesia
Tel
0062215733026
keppin.pusat@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
none
Org. issuing International ID_1
none
Study ID_2
none
Org. issuing International ID_2
none
IND to MHLW
not applicable
Institutions
Institutions
Dental Hospital, Universitas Padjadjaran, Bandung, West Java, Indonesia
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 12 | Month | 20 | 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
0
Results
Not yet conducted
Results date posted
| 2024 | Year | 12 | Month | 20 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Not yet conducted
Date of the first journal publication of results
| 2025 | Year | 10 | Month | 10 | Day |
Baseline Characteristics
smokers unwilling to quit, adult, systematically healthy
Participant flow
From clinical screening
Adverse events
temporary sore mouth and sore throat
Outcome measures
Clinical and biomolecular parameters
Plan to share IPD
none
IPD sharing Plan description
none
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2024 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 01 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2026 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2026 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 2027 | Year | 12 | Month | 01 | Day |
Other
Other related information
none
Management information
Registered date
| 2024 | Year | 12 | Month | 20 | Day |
Last modified on
| 2024 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064589
