Gingivitis and Periodontal DiseasesINPER-THTNCT06784817
Investigating the Periodontal Status of Traditional and Heated Tobacco Product Users
An observational study of Gingivitis and Periodontal Diseases, run by Semmelweis University at 1 site in Hungary.
Trial summary
This cross-sectional observational study aims to compare the clinical and radiographic periodontal status, as well as gingival crevicular fluid volume, among cigarette smokers, heated-tobacco product users, and non-smokers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gingivitis and Periodontal Diseases
- How many people
- 90 participants
- Where
- 1 siteHungary
- Study dates
- 1 Sep 2023to 1 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy induviduals with no systemic diseases will be selected for this study.
Who may be able to join
- Smokers who smoke at least one cigarette daily for the past 12 months.
- Exclusive users of heated tobacco products (e.g., IQOS), using them at least once daily for the past 12 months and not regular traditional cigarette smokers.
- Non-smokers who have never consumed tobacco in any form.
Who cannot join
- Users of electronic cigarettes, smokeless tobacco, waterpipes, or any other tobacco products.
- Dual users of tobacco products.
- Individuals diagnosed with systemic diseases.
- Edentulousness or severe tooth loss (fewer than 20 remaining teeth).
- Individuals who have taken antibiotics, steroids, or non-steroidal anti-inflammatory drugs in the past 90 days.
- Pregnant or breastfeeding women.
Show all 9Show fewer
- History of periodontitis.
- Individuals refusing to sign the written informed consent form.
- Third molars are excluded from examination.
Trial locations and contacts
1 site in 1 country.
Hungary1 site, 1 recruiting
- Recruiting
Semmelweis University Department of Prosthodontics
Budapest, Pest County, 1088
Orsolya Vámos, Dental, +3614591500 ext. 59313, vamos.orsolya@semmelweis.hu
Barbara Kispélyi, Dental, +3614591500 ext. 59332, kispelyi.barbara@semmelweis.hu
About this study
Official title: Investigating the Periodontal Status of Traditional and Heated Tobacco Product Users: A Cross-sectional Observational Study
This cross-sectional observational study aims to compare the clinical and radiographic periodontal status, as well as gingival crevicular fluid volume, among cigarette smokers, heated-tobacco product users, and non-smokers. Specifically, the aim is to determine whether tobacco product users exhibit worse clinical parameters-such as probing pocket depth, bleeding on probing, plaque index, clinical attachment loss-along with greater radiographic bone loss and higher gingival crevicular fluid volume than non-smokers.
Read the detailed description
Smoking is one of the main risk factors of periodontitis and its harmful effects on periodontal health are now well known. Thanks to worldwide restrictions, the use of traditional cigarettes is declining, but new alternative tobacco products such as heated tobacco products (e.g. IQOS, glo) have appeared on the market. These devices are often perceived less harmful by consumers, but there are conflicting results in the literature regarding their health effects.
Only one study has assessed periodontal health in heated tobacco product users, but in this study all participants were former smokers. No studies have evaluated periodontal health in heated tobacco users without a history of smoking traditional cigarettes on a regular basis.
Therefore, the aim of the present cross-sectional observational study is to compare the clinical and radiographic periodontal status and gingival crevicular fluid (GCF) volume among cigarette-smokers, heated-tobacco product users and non-smokers.
The null hypothesis is that different tobacco product users have worse clinical and radiological periodontal parameters and higher GCF volume than non-smokers.
The study will be performed at the Department of Prosthodontics at Semmelweis University, Budapest, Hungary. Patients will be enrolled from the patient material of the Department of Prosthodontics.
- Conditions
- Gingivitis and Periodontal Diseases
- Keywords
- smoking, heated tobacco products, periodontal diseases
- Medical subject headings
- Gingivitis, Periodontal Diseases, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Non-smokers | Never consumed tobacco in any form | |
| Cigarette smokers | Smoking at least 1 cigarette daily for at least 12 months | |
| Heated tobacco product users | Using heated tobacco products e.g. IQOS exclusively at least once daily in the past 12 months and was not a regular traditional cigarette smoker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal bone loss in mm ( MBL)
Digital periapical radiographs will be taken of each tooth and be viewed on a calibrated computer screen using a software program. MBL is defined as the vertical distance from 2 mm below the cemento-enamel junction (CEJ) to the most crestal part of marginal alveolar bone.
Measures of effect: mean and standard deviation
Measured: At baseline (first visit)
Secondary outcomes (5)
Full mouth plaque index (PI)
It is measured at 6 sites per tooth (mesio-buccal, mid-buccal, disto-buccal,disto-lingual/palatal, mid-lingual/palatal and mesio-lingual/palatal) on all maxillary and mandibular teeth, except third molars. It is measured dichotomously. Score 1 if plaque biofilm is present and 0 if plaque biofilm is absent. A percentage score for the whole mouth is obtained by adding together the values for all teeth, dividing by the number of teeth and multiplying the result by 100.
Measures of effect: mean and standard deviation
Measured: At baseline (first visit)
Bleeding on Probing (BOP)
It is measured at 6 sites per tooth (mesio-buccal, mid-buccal, disto-buccal,disto-lingual/palatal, mid-lingual/palatal and mesio-lingual/palatal) on all maxillary and mandibular teeth, except third molars. It is measured dichotomously. Score 1 if bleeding is present and 0 if bleeding is absent. A percentage score for the whole mouth is obtained by adding together the values for all teeth, dividing by the number of teeth and multiplying the result by 100.
Measures of effect: mean and standard deviation
Measured: At baseline (first visit)
Probing Pocket Depth (PPD)
It is measured at 6 sites per tooth (mesio-buccal, mid-buccal, disto-buccal,disto-lingual/palatal, mid-lingual/palatal and mesio-lingual/palatal) on all maxillary and mandibular teeth, except third molars. Using an UNC-15 periodontal probe, the distance from the gingival margin to the base of the periodontal pocket or sulcus is measured. This is recorded in millimeters (mm). Measures of effect: mean and standard deviation
Measured: At baseline (first visit)
Clinical attachment level (CAL)
It is measured at 6 sites per tooth (mesio-buccal, mid-buccal, disto-buccal,disto-lingual/palatal, mid-lingual/palatal and mesio-lingual/palatal) on all maxillary and mandibular teeth, except third molars. To calculate the CAL, the position of the gingival margin relative to the cementoenamel junction (CEJ) and the probing pocket depth is added together. CAL ismeasured in millimeter to the nearest mm using UNC-15 periodontal probe. Measures of effect: mean and standard deviation
Measured: At baseline (first visit)
Gingival Crevicular Fluid (GCF) volume in μL
GCF samples are taken from the deepest periodontal pocket on the buccal aspects of the mesial or distal interproximal sites of a maxillary single rooted tooth. Prior to GCF collection, the selected site is isolated with sterile cotton swabs and the supragingival oral biofilm is carefully removed. The tooth is then dried with a gentle air. A sterile paper strip (Periopaper, Amityville, NY, USA) is placed in the periodontal sulcus until resistance is felt and then held in place for 30 seconds. Samples contaminated with blood or saliva are discarded and a new sample is taken from the same site after 15 minutes. The strips of paper are then immediately placed in a calibrated electronic gingival fluid measuring device (Periotron 8000, Oraflow. Inc., New York) for volume determination.
Measures of effect: mean and standard deviation
Measured: At baseline (first visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start1 Sep 2023
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingivitis and Periodontal DiseasesStudies of the same condition, open and under way.
- More trials run by Semmelweis UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Translational Medicine
- Responsible party
- Sponsor
- Investigators
- Barbara Kispélyi, Dental, Study director, Semmelweis University, Department of ProsthodonticsKata Kelemen, Dental, Study director, Semmelweis University, Department of ProsthodonticsBrigitta Teutsch, Medical doctor, Study chair, Center for Translational Medicine, Semmelweis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06784817
- Sponsor's protocol ID
- SE RKEB 131/2023
- Acronym
- INPER-THT
- Status last verified
- Sep 2024
- First submitted
- 9 Jan 2025
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data supporting our findings will be found in the prepared manuscript and the supplementary material.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Periodontal Status of Traditional and Heated Tobacco Product Users: A Cross-sectional Observational Study
- ClinicalTrials.gov ID
- NCT06784817
- Acronym / sponsor ID
- INPER-THT / SE RKEB 131/2023
- Conditions
- Gingivitis and Periodontal Diseases
- Keywords
- smoking, heated tobacco products, periodontal diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Collaborators
- Center for Translational Medicine
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 20 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This cross-sectional observational study aims to compare the clinical and radiographic periodontal status, as well as gingival crevicular fluid volume, among cigarette smokers, heated-tobacco product users, and non-smokers. Specifically, the aim is to determine whether tobacco product users exhibit worse clinical parameters-such as probing pocket depth, bleeding on probing, plaque index, clinical attachment loss-along with greater radiographic bone loss and higher gingival crevicular fluid volume than non-smokers.
Detailed description
Smoking is one of the main risk factors of periodontitis and its harmful effects on periodontal health are now well known. Thanks to worldwide restrictions, the use of traditional cigarettes is declining, but new alternative tobacco products such as heated tobacco products (e.g. IQOS, glo) have appeared on the market. These devices are often perceived less harmful by consumers, but there are conflicting results in the literature regarding their health effects.
Only one study has assessed periodontal health in heated tobacco product users, but in this study all participants were former smokers. No studies have evaluated periodontal health in heated tobacco users without a history of smoking traditional cigarettes on a regular basis.
Therefore, the aim of the present cross-sectional observational study is to compare the clinical and radiographic periodontal status and gingival crevicular fluid (GCF) volume among cigarette-smokers, heated-tobacco product users and non-smokers.
The null hypothesis is that different tobacco product users have worse clinical and radiological periodontal parameters and higher GCF volume than non-smokers.
The study will be performed at the Department of Prosthodontics at Semmelweis University, Budapest, Hungary. Patients will be enrolled from the patient material of the Department of Prosthodontics.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non-smokers | – | –Never consumed tobacco in any form |
| Cigarette smokers | – | –Smoking at least 1 cigarette daily for at least 12 months |
| Heated tobacco product users | – | –Using heated tobacco products e.g. IQOS exclusively at least once daily in the past 12 months and was not a regular traditional cigarette smoker |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy induviduals with no systemic diseases will be selected for this study.
Key inclusion criteria (3 listed)
- Smokers who smoke at least one cigarette daily for the past 12 months.
- Exclusive users of heated tobacco products (e.g., IQOS), using them at least once daily for the past 12 months and not regular traditional cigarette smokers.
- Non-smokers who have never consumed tobacco in any form.
Key exclusion criteria (9 listed)
- Users of electronic cigarettes, smokeless tobacco, waterpipes, or any other tobacco products.
- Dual users of tobacco products.
- Individuals diagnosed with systemic diseases.
- Edentulousness or severe tooth loss (fewer than 20 remaining teeth).
- Individuals who have taken antibiotics, steroids, or non-steroidal anti-inflammatory drugs in the past 90 days.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Marginal bone loss in mm ( MBL)
Time frame: At baseline (first visit)
Digital periapical radiographs will be taken of each tooth and be viewed on a calibrated computer screen using a software program. MBL is defined as the vertical distance from 2 mm below the cemento-enamel junction (CEJ) to the most crestal part of marginal alveolar bone. Measures of effect: mean and standard deviation
5 secondary outcomes
Full mouth plaque index (PI)
Time frame: At baseline (first visit)
Bleeding on Probing (BOP)
Time frame: At baseline (first visit)
Probing Pocket Depth (PPD)
Time frame: At baseline (first visit)
Clinical attachment level (CAL)
Time frame: At baseline (first visit)
Gingival Crevicular Fluid (GCF) volume in μL
Time frame: At baseline (first visit)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
- Individual participant dataSharing planned: No. All data supporting our findings will be found in the prepared manuscript and the supplementary material.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara Kispélyi, Dental study director
Semmelweis University, Department of Prosthodontics
Kata Kelemen, Dental study director
Semmelweis University, Department of Prosthodontics
Brigitta Teutsch, Medical doctor study chair
Center for Translational Medicine, Semmelweis University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gingivitis and Periodontal Diseases, run by Semmelweis University at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Orsolya Vámos, Dental (+3614591500/59313, vamos.orsolya@semmelweis.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Marginal bone loss in mm ( MBL) (time frame: At baseline (first visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2025.