NCT05736250

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 14, 2022

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 24, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

February 21, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

February 21, 2023

Status Verified

February 1, 2023

Enrollment Period

1.4 years

First QC Date

January 24, 2023

Last Update Submit

February 16, 2023

Conditions

Smoking, Cigarette

Outcome Measures

Primary Outcomes (2)

  • nicotine

    nicotine in gingival fibroblast

    baseline

  • nicotine dependance

    Fagerström test for nicotine dependence

    baseline

Secondary Outcomes (3)

  • salivary cotinine

    baseline

  • number of cigarette consumed

    baseline

  • pack-year

    baseline

Study Arms (1)

TEST group

smoker patients

Diagnostic Test: biopsie

Interventions

biopsieDIAGNOSTIC_TEST

gingival biopsie

TEST group

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

smoker patients

You may qualify if:

  • non smokers
  • smokers

You may not qualify if:

  • not able to have biopsie

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Salhi

Liège, Liege, 4000, Belgium

RECRUITING

MeSH Terms

Conditions

Cigarette Smoking

Condition Hierarchy (Ancestors)

Tobacco SmokingSmokingBehaviorTobacco Use

Central Study Contacts

Leila Salhi, PhD

CONTACT

003243233123l.salhi@chuliege.be

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, head of clinic, Department of periodontology, buccal surgery and buccal implantology,

Study Record Dates

First Submitted

January 24, 2023

First Posted

February 21, 2023

Study Start

January 14, 2022

Primary Completion

June 1, 2023

Study Completion

June 1, 2023

Last Updated

February 21, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)