Clinical and Biomolecular Study Evaluating The Effect of Switching from Tobacco Cigarettes to Combustion-Free Nicotine Delivery Systems on Gingiva, A Randomized-Controlled Trial

Evaluating the Effect of Switching from Tobacco Cigarettes to Combustion-Free Nicotine Delivery Systems on Gingiva, a Randomized-Controlled Trial - Effect of Switching from Tobacco Cigarettes to CF-NDS on Gingiva

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000056524

Enrollment

Registered

2024-12-20

Start date

2025-03-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systematically and periodontally healthy subjects, with a maximum of slight periodontitis

Interventions

Intervention Group : The subject has to quit smoking tobacco cigarettes and will be given C-FNDS for 3 months Control Group: The subject continues the smoking habit without any interventions

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
To evaluate the change in clinical parameters and biomarkers in gingiva and saliva after switching from tobacco cigarettes to C-F NDS	—

Secondary

Measure	Time frame
To evaluate the change in bacterial LPS and olfa-gustatory perceptions	—

Countries

Asia(except Japan)

Contacts

Public ContactAmaliya Amaliya

Dental Faculty, Universitas Padjadjaran, Bandung - West Java, INDONESIA Periodontology

amaliya@unpad.ac.id0062222504985

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026