Smoking, CigaretteNCT05736250
Establishment of a Method for Extraction and Quantification of Gingival Tissue Nicotine y
An observational study of Smoking, Cigarette, run by University of Liege at 1 site in Belgium.
Trial summary
establishment of a method for extraction and quantification of gingival tissue nicotine in relation to conventional tobacco biomarkers: a pilot study Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking, Cigarette
- What is being tested?
- biopsie
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 14 Jan 2022to Jun 2023
- 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: smoker patients
Who may be able to join
- non smokers
- smokers
Who cannot join
- not able to have biopsie
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Salhi
Liège, Liege, 4000
Leila Salhi, PhD
About this study
Official title: Establishment of a Method for Extraction and Quantification of Gingival Tissue Nicotine in Relation to Conventional Tobacco Biomarkers: a Pilot Study
establishment of a method for extraction and quantification of gingival tissue nicotine in relation to conventional tobacco biomarkers: a pilot study
Read the detailed description
The study aim to establish a method for extraction and quantification of gingival tissue nicotine. Additionnaly, the relationship between the nicotine tissue intoxication with others smoking indicators will be evaluated as mentionned in the following PICO question:
- P: Smoker patients
- I: Biopsie of gingival tissue
- C: Non-smoker patient
- O: nicotine dependence test (FTND), salivary cotinine, fibroblast nicotine, number of cigarette consumed per day (NCC) and the pack-year (PY)
- Conditions
- Smoking, Cigarette
- Being tested
- biopsie
- Medical subject headings
- Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biopsieDiagnostic test
gingival biopsie
| Study group | Role | What they receive |
|---|---|---|
| TEST group | smoker patients Receives: Diagnostic Test: biopsie |
What is being measured
The primary outcome is the main question the study is designed to answer.
nicotine
nicotine in gingival fibroblast
Measured: baseline
nicotine dependance
Fagerström test for nicotine dependence
Measured: baseline
Secondary outcomes (3)
salivary cotinine
Measured: baseline
number of cigarette consumed
Measured: baseline
pack-year
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start14 Jan 2022
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking, CigaretteStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leila Salhi, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05736250
- Sponsor's protocol ID
- 2021:250
- Status last verified
- Feb 2023
- First submitted
- 24 Jan 2023
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of a Method for Extraction and Quantification of Gingival Tissue Nicotine in Relation to Conventional Tobacco Biomarkers: a Pilot Study
- ClinicalTrials.gov ID
- NCT05736250
- Acronym / sponsor ID
- 2021:250
- Conditions
- Smoking, Cigarette
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 14 Jan 2022 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 21 Feb 2023 (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.
establishment of a method for extraction and quantification of gingival tissue nicotine in relation to conventional tobacco biomarkers: a pilot study
Detailed description
The study aim to establish a method for extraction and quantification of gingival tissue nicotine. Additionnaly, the relationship between the nicotine tissue intoxication with others smoking indicators will be evaluated as mentionned in the following PICO question:
- P: Smoker patients
- I: Biopsie of gingival tissue
- C: Non-smoker patient
- O: nicotine dependence test (FTND), salivary cotinine, fibroblast nicotine, number of cigarette consumed per day (NCC) and the pack-year (PY)
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TEST group | – | Diagnostic Test: biopsiesmoker patients |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- smoker patients
Key inclusion criteria (2 listed)
- non smokers
- smokers
Key exclusion criteria (1 listed)
- not able to have biopsie
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biopsiegingival biopsie | Diagnostic test | TEST group |
Primary outcome
nicotine
Time frame: baseline
nicotine in gingival fibroblast
nicotine dependance
Time frame: baseline
Fagerström test for nicotine dependence
3 secondary outcomes
salivary cotinine
Time frame: baseline
number of cigarette consumed
Time frame: baseline
pack-year
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Individual participant dataSharing planned: No
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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.
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 Smoking, Cigarette, run by University of Liege at 1 site in Belgium.
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 2 inclusion and 1 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 21 Feb 2023. 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 Belgium. 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 Leila Salhi, PhD (003243233123, l.salhi@chuliege.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
nicotine (time frame: baseline). The study lists 2 primary outcomes in all. 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 21 Feb 2023.