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

February 16, 2023 updated by: Leila Salhi, University of Liege

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
    • Liege
      • Liège, Liege, Belgium, 4000
        • Recruiting
        • Salhi
        • Contact:
          • Leila Salhi, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

smoker patients

Description

Inclusion Criteria:

  • non smokers
  • smokers

Exclusion Criteria:

  • not able to have biopsie

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
TEST group
smoker patients
Diagnostic test: biopsie
gingival biopsie

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
nicotine
Time Frame: baseline
nicotine in gingival fibroblast
baseline
nicotine dependance
Time Frame: baseline
Fagerström test for nicotine dependence
baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
salivary cotinine
Time Frame: baseline
baseline
number of cigarette consumed
Time Frame: baseline
baseline
pack-year
Time Frame: baseline
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Liege

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 14, 2022

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

January 24, 2023

First Submitted That Met QC Criteria

February 16, 2023

First Posted (Estimate)

February 20, 2023

Study Record Updates

Last Update Posted (Estimate)

February 20, 2023

Last Update Submitted That Met QC Criteria

February 16, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 2021:250

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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