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Smokers who switch to 'Smokeless' nicotine may see healthier gums, study finds

NCT ID NCT04649645

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study looked at whether smokers who switch to combustion-free nicotine products (like e-cigarettes or heated tobacco) see improvements in their gum health and tooth appearance. 460 smokers with mild gum disease were randomly assigned to keep smoking, switch to these products, or be never-smokers. Researchers tracked changes in gum inflammation, plaque, and tooth staining over 18 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Combustion-free nicotine delivery systems (e-cigarettes or heated tobacco products)
What this could lead to
If successful, this could show that switching to these products improves gum health and reduces staining compared to continued smoking.
What could go wrong
This is a completed trial, but results may not apply to all smokers. The products still contain nicotine and may have other health risks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

460 people

The number who actually took part.

Started

Oct 2021

Finished

Dec 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Addendo srl

    Catania, Catania, 95100, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.