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Changes in Oral Health in Tobacco Cigarettes Smokers After Switching to Combustion-Free Nicotine Delivery Systems (SMILE)

Primary Purpose

Gingivitis, Periodontal Diseases

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
TOBACCO CIGARETTES
COMBUSTION-FREE NICOTINE DELIVERY SYSTEMS (C-F NDS)
NOT SMOKING
Sponsored by
Eclat Srl.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Gingivitis focused on measuring Electronic cigarettes, Tobacco Harm Reduction, Heated tobacco products, Smokers, Gingivitis, Modified gingival index, Oral Health, Tooth stain, Periodontitis, Dental plaque imaging, Dental discoloration

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 lifetime and none in the 30 days prior to screening.
    • with an exhaled breath CO level < 7 ppm at screening.
  • willing to not smoke or use any form of tobacco or nicotine-containing products for the whole duration of the study.

Exclusion Criteria:

  • Pregnancy.
  • Presence of extensive crown or bridge work, dental implants, and/or rampant decay (per Investigator/Examiner discretion)
  • Significant oral soft tissue pathology or any type of gingival overgrowth, other than plaque-induced gingivitis and mild periodontitis (Stage I)
  • Moderate to Severe Periodontitis (Stage II, III and IV) based on 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions, which require:

    • Detectable Interdental Clinical Attachment Loss (CAL) ≥ 3 mm at ≥ 2 non-adjacent teeth.
    • Buccal or Oral CAL ≥3 mm with pocketing ≥ 5 mm detectable at ≥ 2 teeth.
  • Removable dentures or fixed and removable orthodontic appliance (except fixed lingual wires).
  • Significant history of alcoholism or drug abuse (other than tobacco/nicotine) within 24 months prior to screening, as determined by the Investigator.
  • A course of treatment with any medications or substances (other than tobacco/nicotine) which:

    • interfere with the cyclooxygenase pathway (e.g. anti-inflammatory drugs including aspirin and ibuprofen) within 3 days prior to each visit.
    • are known to have antibacterial activity (e.g. antibiotics) within 7 days prior to each visit.

Sites / Locations

  • Addendo srl

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Standard Arm (Arm A)

Intervention Arm (Arm B)

Control Arm (Arm C)

Arm Description

Participant continues smoking their own cigarette brand.

Participant switches to using C-F NDS.

Participant continues to not smoking or using of any nicotine/tobacco products.

Outcomes

Primary Outcome Measures

Modified Gingival Index (MGI)
Percentage (%) mean changes in MGI from baseline at different study time-points

Secondary Outcome Measures

Macpherson Modification of Lobene Tooth Stain Index (MLSI)
Change in MLSI from baseline at different study time-points
Dental Discolorations
Percentage (%) mean change in dental shade (L, a*, b*) from baseline at different study time-points
Plaque Score Imaging (QLF)
Changes in ΔR30 and ΔR120 from baseline at different study time-points
Oral Health Quality of Life (OHQOL)
Changes in OHQOL from baseline at different study time-points
EuroQoL Visual Analog Scale (EQ VAS - QoL)
Changes in EQ VAS-QoL from baseline at different study time-points

Full Information

First Posted
November 25, 2020
Last Updated
February 18, 2021
Sponsor
Eclat Srl.
Collaborators
University of Catania
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1. Study Identification

Unique Protocol Identification Number
NCT04649645
Brief Title
Changes in Oral Health in Tobacco Cigarettes Smokers After Switching to Combustion-Free Nicotine Delivery Systems
Acronym
SMILE
Official Title
International Randomized Controlled Trial Evaluating Changes in Oral Health in Smokers After Switching to Combustion-Free Nicotine Delivery Systems: SMILE Study Protocol
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 28, 2021 (Anticipated)
Primary Completion Date
February 28, 2023 (Anticipated)
Study Completion Date
April 28, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eclat Srl.
Collaborators
University of Catania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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 1:4 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 C.The 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 smoking/C-F NDS and/or 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 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. 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 1:4 randomization ratio scheme (i.e. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis, Periodontal Diseases
Keywords
Electronic cigarettes, Tobacco Harm Reduction, Heated tobacco products, Smokers, Gingivitis, Modified gingival index, Oral Health, Tooth stain, Periodontitis, Dental plaque imaging, Dental discoloration

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
606 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard Arm (Arm A)
Arm Type
Active Comparator
Arm Description
Participant continues smoking their own cigarette brand.
Arm Title
Intervention Arm (Arm B)
Arm Type
Active Comparator
Arm Description
Participant switches to using C-F NDS.
Arm Title
Control Arm (Arm C)
Arm Type
Active Comparator
Arm Description
Participant continues to not smoking or using of any nicotine/tobacco products.
Intervention Type
Other
Intervention Name(s)
TOBACCO CIGARETTES
Intervention Description
Participants in Arm A will continue smoking their own cigarette brand as usual.
Intervention Type
Other
Intervention Name(s)
COMBUSTION-FREE NICOTINE DELIVERY SYSTEMS (C-F NDS)
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
NOT SMOKING
Intervention Description
Participants in Arm C will continue not smoking or use any form of tobacco or nicotine-containing products.
Primary Outcome Measure Information:
Title
Modified Gingival Index (MGI)
Description
Percentage (%) mean changes in MGI from baseline at different study time-points
Time Frame
Changes in the severity of gingivitis from baseline will be assessed at 3 months, 6 months, 12 months and 18 months
Secondary Outcome Measure Information:
Title
Macpherson Modification of Lobene Tooth Stain Index (MLSI)
Description
Change in MLSI from baseline at different study time-points
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
Title
Dental Discolorations
Description
Percentage (%) mean change in dental shade (L, a*, b*) from baseline at different study time-points
Time Frame
Changes in dental discolouration from baseline will be assessed at 3 months, 6 months, 12 months and 18 months
Title
Plaque Score Imaging (QLF)
Description
Changes in ΔR30 and ΔR120 from baseline at different study time-points
Time Frame
Changes in dental plaque from baseline will be assessed at 3 months, 6 months, 12 months and 18 months
Title
Oral Health Quality of Life (OHQOL)
Description
Changes in OHQOL from baseline at different study time-points
Time Frame
Changes in OHQOL score from baseline will be assessed at 3 months, 6 months, 12 months and 18 months
Title
EuroQoL Visual Analog Scale (EQ VAS - QoL)
Description
Changes in EQ VAS-QoL from baseline at different study time-points
Time Frame
Changes in the EQ VAS - QoL score from baseline will be assessed at 3 months, 6 months, 12 months and 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 lifetime and none in the 30 days prior to screening. with an exhaled breath CO level < 7 ppm at screening. willing to not smoke or use any form of tobacco or nicotine-containing products for the whole duration of the study. Exclusion Criteria: Pregnancy. Presence of extensive crown or bridge work, dental implants, and/or rampant decay (per Investigator/Examiner discretion) Significant oral soft tissue pathology or any type of gingival overgrowth, other than plaque-induced gingivitis and mild periodontitis (Stage I) Moderate to Severe Periodontitis (Stage II, III and IV) based on 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions, which require: Detectable Interdental Clinical Attachment Loss (CAL) ≥ 3 mm at ≥ 2 non-adjacent teeth. Buccal or Oral CAL ≥3 mm with pocketing ≥ 5 mm detectable at ≥ 2 teeth. Removable dentures or fixed and removable orthodontic appliance (except fixed lingual wires). Significant history of alcoholism or drug abuse (other than tobacco/nicotine) within 24 months prior to screening, as determined by the Investigator. A course of treatment with any medications or substances (other than tobacco/nicotine) which: interfere with the cyclooxygenase pathway (e.g. anti-inflammatory drugs including aspirin and ibuprofen) within 3 days prior to each visit. are known to have antibacterial activity (e.g. antibiotics) within 7 days prior to each visit.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gianluca Conte, D.D.S.
Phone
00393400912034
Email
gianluca.conte@eclatrbc.it
First Name & Middle Initial & Last Name or Official Title & Degree
Salvatore Urso, M.Sc.
Phone
00390954781471
Email
toti.urso@eclatrbc.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Pacino, D.D.S.
Organizational Affiliation
Addendo srl, Catania, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Addendo srl
City
Catania
ZIP/Postal Code
95100
Country
Italy
Facility Contact:
Phone
00390952191853
Email
info@addendo.net
First Name & Middle Initial & Last Name & Degree
Antonio S. Pacino, D.D.S.

12. IPD Sharing Statement

Plan to Share IPD
No
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Changes in Oral Health in Tobacco Cigarettes Smokers After Switching to Combustion-Free Nicotine Delivery Systems

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