Establishment of a Method for Extraction and Quantificati... | NCT05736250

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

NCT05736250

Sponsor

University of Liege

Status

Unknown status

Last Update Posted

Feb 21, 2023Actual

Enrollment

20Estimated

Phase

Not provided

Conditions

Smoking, Cigarette

Interventions

biopsie

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 14, 2022Actual

Primary Completion Date

Jun 2023Estimated

Completion Date

Jun 2023Estimated

First Submitted Date

Jan 24, 2023

First Submission Date that Met QC Criteria

Feb 16, 2023

First Posted Date

Feb 21, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 16, 2023

Last Update Posted Date

Feb 21, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Leila Salhi, PhD, head of clinic, Department of periodontology, buccal surgery and buccal implantology,, University of LiegePrincipal Investigator

Lead Sponsor

University of LiegeOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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)

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TEST group		smoker patients	Diagnostic Test: biopsie

Interventions

Name	Type	Description	Arm Group Labels	Other Names
biopsie	Diagnostic Test	gingival biopsie	TEST group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

non smokers
smokers

Exclusion Criteria:

not able to have biopsie

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

smoker patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Leila Salhi, PhD	Contact	003243233123		l.salhi@chuliege.be

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Salhi	Recruiting	Liège	Liege	4000	Belgium

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000073865	Cigarette Smoking

Ancestor Terms

ID	Term
D000073869	Tobacco Smoking
D012907	Smoking
D001519	Behavior
D064424	Tobacco Use

Browse Leaves

Not provided

Browse Branches

Not provided