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

NCT04649645 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 460

Last updated 2025-09-08

No results posted yet for this study

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.

Conditions

  • Gingivitis
  • Periodontal Diseases

Interventions

OTHER

TOBACCO CIGARETTES

Participants in Arm A will continue smoking their own cigarette brand as usual.

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).

OTHER

NOT SMOKING

Participants in Arm C will continue not smoking or use any form of tobacco or nicotine-containing products.

Sponsors & Collaborators

  • University of Catania

    collaborator OTHER

  • Eclat Srl.

    lead OTHER

Principal Investigators

  • Antonio Pacino, D.D.S. · Addendo srl, Catania, Italy

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-18
Primary Completion
2024-12-19
Completion
2024-12-19

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04649645 on ClinicalTrials.gov