Changes in Oral Health in Tobacco Cigarettes Smokers After Switching to Combustion-Free Nicotine … (NCT04649645) | Clinical Trial Compass
CompletedNot Applicable
Changes in Oral Health in Tobacco Cigarettes Smokers After Switching to Combustion-Free Nicotine Delivery Systems
Italy460 participantsStarted 2021-10-18
Plain-language summary
Although the well-known detrimental effects of conventional cigarette smoking on oral health, there are still lack of evidences about the impact of less harmful alternatives (such as electronic cigarettes or heat not burn products), especially in young smokers with clinical absence of signs of moderate to severe periodontitis.
This study aims to investigate whether cigarette smokers who switch to combustion-free nicotine delivery systems (C-F NDS) undergo measurable improvements in oral health parameters and teeth appearance, comparing short- and long-term impact on periodontal health between smokers continuing with conventional cigarette smoking, those switching to combustion-free nicotine delivery systems (C-F NDS), and never-smokers.
The investigator propose a prospective, multicenter, interventional, open label, randomized, controlled, three parallel-arms study assessing oral health parameters and teeth appearance of 18 months duration.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Demonstrate understanding of the study and willingness to participate in the study by providing a signed written informed consent
* Healthy subjects, not taking regular medications for chronic medical conditions
* Adults, age at least 18 years old.
* Presence of at least 10 natural anterior teeth in total (cuspid to cuspid, lower and upper jaw).
* Presence of at least 18 'scorable' teeth with scorable facial and lingual surfaces. Teeth that are grossly carious, orthodontically banded, exhibiting general cervical abrasion and/or enamel abrasion, and third molars will not be included in the tooth count;
* Willingness and ability to comply with the requirements of the study including installing an APP on their digital device, e.g. smart phone or tablet.
For Arms A and B, subject have to be:
* Regular smokers, defined as:
* Smoked for at least five consecutive years prior to Screening.
* Smoked \>10 and \< 30 cigarettes per day (CPD).
* with an exhaled breath carbon monoxide (CO) level ≥7 ppm at Screening.
* willing to regularly use of any nicotine or tobacco product other than their own conventional cigarettes brand within 14 days prior to Screening.
* willing to change to use of study products or if randomized to Arm A continuing to use their own brand of conventional cigarettes for the whole duration of the study.
For Arm C, subjects have to be:
* Never-smokers, defined as:
* never smoked or who have smoked \< 100 cigarettes in their lifeti…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Modified Gingival Index (MGI)
Timeframe: Changes in the severity of gingivitis from baseline will be assessed at 3 months, 6 months, 12 months and 18 months