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 range18 Years
SexALL
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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…
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