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NCT05736250 Clinical Trial

Establishment of a Method for Extraction and Quantification of Gingival Tissue Nicotine y

Smoking, Cigarette Clinical Trial

Official title:
Establishment of a Method for Extraction and Quantification of Gingival Tissue Nicotine in Relation to Conventional Tobacco Biomarkers: a Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05736250
Other study ID # 2021:250
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 14, 2022
Est. completion date June 2023

Study information
Verified date February 2023
Source University of Liege
Contact Leila Salhi, PhD
Phone 003243233123
Email l.salhi@chuliege.be
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

establishment of a method for extraction and quantification of gingival tissue nicotine in relation to conventional tobacco biomarkers: a pilot study

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)

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date June 2023
Est. primary completion date June 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - non smokers - smokers Exclusion Criteria: - not able to have biopsie

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• biopsie
gingival biopsie

Locations
Country Name City State
Belgium Salhi Liège Liege

Sponsors (1)
Lead Sponsor Collaborator
University of Liege

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary nicotine nicotine in gingival fibroblast baseline
Primary nicotine dependance Fagerström test for nicotine dependence baseline
Secondary salivary cotinine baseline
Secondary number of cigarette consumed baseline
Secondary pack-year baseline
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