Changes in Oral Health in Tobacco Cigarettes Smokers After Switching to Combustion-Free Nicotine Delivery Systems (SMILE)
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|ClinicalTrials.gov Identifier: NCT04649645|
Recruitment Status : Not yet recruiting
First Posted : December 2, 2020
Last Update Posted : February 21, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Gingivitis Periodontal Diseases||Other: TOBACCO CIGARETTES Other: COMBUSTION-FREE NICOTINE DELIVERY SYSTEMS (C-F NDS) Other: NOT SMOKING||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||606 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
Smokers participants who were eligible and consent to take part will be randomized to either continuing smoking their own cigarette brand (Arm A) or switching to using C-F NDS (Arm B). Never-smokers participants who were eligible and consent to take part will be assigned to Arm C.
The randomization sequence will be computer generated, with an allocation ratio of 1:4 (Study Arm A : Study Arm B; Smokers : N-C NDS users) to compensate for an estimated 25% success rate (combined smoking abstinence rate + >90% smoking reduction rate) in the long term. The randomization scheme will be provided to clinical sites via a web-based application set up by the CRO. The staff randomizing the participant will access the web-based application when the participant is with them, entering their participant identification number, date of birth and initials into the program. The allocation will be immediately provided by the program/software.
|Masking:||None (Open Label)|
|Official Title:||International Randomized Controlled Trial Evaluating Changes in Oral Health in Smokers After Switching to Combustion-Free Nicotine Delivery Systems: SMILE Study Protocol|
|Estimated Study Start Date :||February 28, 2021|
|Estimated Primary Completion Date :||February 28, 2023|
|Estimated Study Completion Date :||April 28, 2023|
Active Comparator: Standard Arm (Arm A)
Participant continues smoking their own cigarette brand.
Other: TOBACCO CIGARETTES
Participants in Arm A will continue smoking their own cigarette brand as usual.
Active Comparator: Intervention Arm (Arm B)
Participant switches to using C-F NDS.
Other: COMBUSTION-FREE NICOTINE DELIVERY SYSTEMS (C-F NDS)
Participants in Arm B will trial and familiarize with a selection of C-F NDS in order to choose the product of their preference. They will be trained and counselled on the chosen C-F NDS. Prior to check-out, participants wishing to use a heated tobacco device will receive one kit and a full 2 weeks supply of tobacco sticks of their choice (they will receive a number of tobacco sticks per day corresponding to the number of cigarettes smoked at baseline); those wishing to use a vaping product will receive one vaping kit and a full 2 weeks supply of e-liquids of their choice (they will receive twelve 10 ml refill containers).
Active Comparator: Control Arm (Arm C)
Participant continues to not smoking or using of any nicotine/tobacco products.
Other: NOT SMOKING
Participants in Arm C will continue not smoking or use any form of tobacco or nicotine-containing products.
- Modified Gingival Index (MGI) [ Time Frame: Changes in the severity of gingivitis from baseline will be assessed at 3 months, 6 months, 12 months and 18 months ]Percentage (%) mean changes in MGI from baseline at different study time-points
- Macpherson Modification of Lobene Tooth Stain Index (MLSI) [ Time Frame: Changes in extent and severity of tooth stains from baseline will be assessed at 3 months, 6 months, 12 months and 18 months ]Change in MLSI from baseline at different study time-points
- Dental Discolorations [ Time Frame: Changes in dental discolouration from baseline will be assessed at 3 months, 6 months, 12 months and 18 months ]Percentage (%) mean change in dental shade (L, a*, b*) from baseline at different study time-points
- Plaque Score Imaging (QLF) [ Time Frame: Changes in dental plaque from baseline will be assessed at 3 months, 6 months, 12 months and 18 months ]Changes in ΔR30 and ΔR120 from baseline at different study time-points
- Oral Health Quality of Life (OHQOL) [ Time Frame: Changes in OHQOL score from baseline will be assessed at 3 months, 6 months, 12 months and 18 months ]Changes in OHQOL from baseline at different study time-points
- EuroQoL Visual Analog Scale (EQ VAS - QoL) [ Time Frame: Changes in the EQ VAS - QoL score from baseline will be assessed at 3 months, 6 months, 12 months and 18 months ]Changes in EQ VAS-QoL from baseline at different study time-points
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04649645
|Contact: Gianluca Conte, D.D.S.||email@example.com|
|Contact: Salvatore Urso, M.Sc.||firstname.lastname@example.org|
|Catania, Italy, 95100|
|Contact 00390952191853 email@example.com|
|Principal Investigator: Antonio S. Pacino, D.D.S.|
|Principal Investigator:||Antonio Pacino, D.D.S.||Addendo srl, Catania, Italy|