Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04649645
Recruitment Status : Not yet recruiting
First Posted : December 2, 2020
Last Update Posted : February 21, 2021
Sponsor:
Collaborator:
University of Catania
Information provided by (Responsible Party):
Eclat Srl.

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.


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

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 606 participants
Allocation: Randomized
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)
Primary Purpose: Screening
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dental Health

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Gianluca Conte, D.D.S. 00393400912034 gianluca.conte@eclatrbc.it
Contact: Salvatore Urso, M.Sc. 00390954781471 toti.urso@eclatrbc.it

Locations
Layout table for location information
Italy
Addendo srl
Catania, Italy, 95100
Contact    00390952191853    info@addendo.net   
Principal Investigator: Antonio S. Pacino, D.D.S.         
Sponsors and Collaborators
Eclat Srl.
University of Catania
Investigators
Layout table for investigator information
Principal Investigator: Antonio Pacino, D.D.S. Addendo srl, Catania, Italy
Publications:
Ueno M, Ohara S, Sawada N, Inoue M, Tsugane S, Kawaguchi Y. The association of active and secondhand smoking with oral health in adults: Japan public health center-based study. Tob Induc Dis. 2015 Jul 29;13(1):19. doi: 10.1186/s12971-015-0047-6. PMID: 26225132; PMCID: PMC4518564.Eriksen HM, Nordbø H. Extrinsic discoloration of teeth. J Clin Periodontol. 1978;5(4):229-236. doi:10.1111/j.1600-051x.1978.tb01916.x
McNeill A, Brose L S, Calder R, Bauld L and Robson D. Evidence review of e-cigarettes and heated tobacco products 2018. A report commissioned by Public Health England.

Layout table for additonal information
Responsible Party: Eclat Srl.
ClinicalTrials.gov Identifier: NCT04649645    
Other Study ID Numbers: COE1-05-SMILE
First Posted: December 2, 2020    Key Record Dates
Last Update Posted: February 21, 2021
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eclat Srl.:
Electronic cigarettes
Tobacco Harm Reduction
Heated tobacco products
Smokers
Gingivitis
Modified gingival index
Oral Health
Tooth stain
Periodontitis
Dental plaque imaging
Dental discoloration
Additional relevant MeSH terms:
Layout table for MeSH terms
Periodontal Diseases
Gingivitis
Mouth Diseases
Stomatognathic Diseases
Gingival Diseases
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action