Ignite Creation Date:
2024-05-06 @ 3:28 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04649645
Status:
UNKNOWN
Last Update Posted:
2021-02-21
First Post:
2020-11-25
Brief Title:
Changes in Oral Health in Tobacco Cigarettes Smokers After Switching to Combustion-Free Nicotine Delivery Systems
Sponsor:
Eclat Srl
Organization:
Eclat Srl
Study Overview
Official Title:
International Randomized Controlled Trial Evaluating Changes in Oral Health in Smokers After Switching to Combustion-Free Nicotine Delivery Systems SMILE Study Protocol
Status:
UNKNOWN
Status Verified Date:
2020-11
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SMILE
Brief 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
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
Detailed Description:
SMILE is an international open label randomized controlled study of 18 months duration designed to assess whether cigarette smokers switching to combustion free-nicotine delivery systems C-F NDS will undergo measurable improvements in oral health parameters and teeth appearance as a consequence of avoiding exposure to cigarette smoke Five countries have so far agreed to participate Italy Moldova Poland UK and Indonesia An amendment will be submitted to the REC once the final two countries are signed up
A volunteer population of never-smokers and regular smokers of conventional cigarettes with a clinical absence of signs of periodontitis will be recruited Regular cigarette smokers will be randomized 14 ratio either continuing to smoke commercially manufactured conventional cigarettes Study Arm A or switching to C-F NDS Study Arm B Never Smokers will be assigned to Arm CThe intended minimum number of participants in each arm by the end of the study is 84
Before randomization all smokers will be reminded of the risks associated with smoking and will be offered a free smoking cessation program according to standard local guidelines and depending on the local availability of antismoking services Those who decline the invitation will be eligible for recruitment into the study
Smokers are free to voluntarily quit smokingC-F NDS andor withdraw from the study at any time
Duration
All participants will attend a total of seven clinics visits Day -28 to Day -1 - Screening Day 0 - Enrollment and Randomization Visit 0 Day 14 -3 days - Baseline Visit Visit 1 Day 90 -5 days - Visit 2 Day 180 -7 days - Visit 3 Day 360 -10 days - Visit 4 Day 540 -10 days - Visit 5
Each participant will undergo screening within 28 days prior to Visit 0 Eligible participants will be enrolled and randomized on Visit 0 Baseline assessments will be performed at Visit 1 14 days after Visit 0 The overall duration of study participation for each participant will be a maximum of 568 - 10 days
The randomization sequence will be computer generated with an allocation ratio of 14 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 programsoftware
Product use Regular smokers will continue to smoke their usual brand of conventional cigarette until Baseline on Visit 1 After Visit 1 participants on both Arms A and B will be asked to use only their assigned products ad libitum for the whole duration of the study
Participants in Arm A will continue smoking their own conventional cigarette brand as usual
Participants in Arm B will have the option to try and choose among a selection of either three e-liquids or three tobacco sticks depending on the C-F NDS they have chosen They will also be trained and instructed on how to correctly use their chosen C-F NDS Participants wishing to use a heated tobacco device HTD will receive the number of tobacco sticks per day corresponding to the number of cigarettes smoked per day at baseline Participants wishing to use a vaping product will receive one vaping kit and supply of e-liquids of their choice enough to provide consumption in between supply visits see Table 2 on average they will receive 4 x 10 ml refill containers per week Free products will be supplied at each subsequent visit throughout the whole duration of the study
Participants in Arm C will continue to not smoking or use any form of tobacco or nicotine-containing products
A prospective monitoring of cigarette consumption C-F NDS use and oral hygiene routine will be carried out throughout the study with the tracker APP Moreover participants in Arm B will be asked to return all empty part-used and unused consumables tobacco sticks e-cigarette cartridges e-liquid refill bottles at each study visit
Justification for Study Design
Participants in this study will be a minimum of 18 years of age This is based on
The legal age to obtain tobacco products is 18 years
The presence of at least 10 natural anterior permanent teeth in total cuspid to cuspid lower and upper jaw
To investigate the effects of abstaining from smoking by switching in smokers with clinical absence of periodontitis a population of both smokers who are intending to make the switch to N-C NDS and never-smokers will be recruited By the end of the study it is estimated that a high proportion approx 75 of patients randomized in the Arm B of the study will not be able to achieve success defined as either complete smoking abstinence or as at least 90 smoking reduction To account for this the C-F NDS population will be over sampled and a 14 randomization ratio scheme ie for every patient randomized in the continue-to-smoke population four will be randomized in the C-F NDS population will be adopted
It will not be possible to blind participants to the intervention they will be receiving It will not be possible to blind trial staff when providing the interventions and collecting data However data analyses will be conducted blind to Study Arms allocation All other trial staff who have access to outcome data will remain blinded until prespecified data analyses will be completed
A volunteer population of never-smokers and regular smokers of conventional cigarettes with a clinical absence of signs of periodontitis will be recruited Regular cigarette smokers will be randomized 14 ratio either continuing to smoke commercially manufactured conventional cigarettes Study Arm A or switching to C-F NDS Study Arm B Never Smokers will be assigned to Arm CThe intended minimum number of participants in each arm by the end of the study is 84
Before randomization all smokers will be reminded of the risks associated with smoking and will be offered a free smoking cessation program according to standard local guidelines and depending on the local availability of antismoking services Those who decline the invitation will be eligible for recruitment into the study
Smokers are free to voluntarily quit smokingC-F NDS andor withdraw from the study at any time
Duration
All participants will attend a total of seven clinics visits Day -28 to Day -1 - Screening Day 0 - Enrollment and Randomization Visit 0 Day 14 -3 days - Baseline Visit Visit 1 Day 90 -5 days - Visit 2 Day 180 -7 days - Visit 3 Day 360 -10 days - Visit 4 Day 540 -10 days - Visit 5
Each participant will undergo screening within 28 days prior to Visit 0 Eligible participants will be enrolled and randomized on Visit 0 Baseline assessments will be performed at Visit 1 14 days after Visit 0 The overall duration of study participation for each participant will be a maximum of 568 - 10 days
The randomization sequence will be computer generated with an allocation ratio of 14 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 programsoftware
Product use Regular smokers will continue to smoke their usual brand of conventional cigarette until Baseline on Visit 1 After Visit 1 participants on both Arms A and B will be asked to use only their assigned products ad libitum for the whole duration of the study
Participants in Arm A will continue smoking their own conventional cigarette brand as usual
Participants in Arm B will have the option to try and choose among a selection of either three e-liquids or three tobacco sticks depending on the C-F NDS they have chosen They will also be trained and instructed on how to correctly use their chosen C-F NDS Participants wishing to use a heated tobacco device HTD will receive the number of tobacco sticks per day corresponding to the number of cigarettes smoked per day at baseline Participants wishing to use a vaping product will receive one vaping kit and supply of e-liquids of their choice enough to provide consumption in between supply visits see Table 2 on average they will receive 4 x 10 ml refill containers per week Free products will be supplied at each subsequent visit throughout the whole duration of the study
Participants in Arm C will continue to not smoking or use any form of tobacco or nicotine-containing products
A prospective monitoring of cigarette consumption C-F NDS use and oral hygiene routine will be carried out throughout the study with the tracker APP Moreover participants in Arm B will be asked to return all empty part-used and unused consumables tobacco sticks e-cigarette cartridges e-liquid refill bottles at each study visit
Justification for Study Design
Participants in this study will be a minimum of 18 years of age This is based on
The legal age to obtain tobacco products is 18 years
The presence of at least 10 natural anterior permanent teeth in total cuspid to cuspid lower and upper jaw
To investigate the effects of abstaining from smoking by switching in smokers with clinical absence of periodontitis a population of both smokers who are intending to make the switch to N-C NDS and never-smokers will be recruited By the end of the study it is estimated that a high proportion approx 75 of patients randomized in the Arm B of the study will not be able to achieve success defined as either complete smoking abstinence or as at least 90 smoking reduction To account for this the C-F NDS population will be over sampled and a 14 randomization ratio scheme ie for every patient randomized in the continue-to-smoke population four will be randomized in the C-F NDS population will be adopted
It will not be possible to blind participants to the intervention they will be receiving It will not be possible to blind trial staff when providing the interventions and collecting data However data analyses will be conducted blind to Study Arms allocation All other trial staff who have access to outcome data will remain blinded until prespecified data analyses will be completed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None