HIF-1 Alpha, VEGF and MMP-8 Levels in PICF of Smokers Ver... | NCT05325918

Studies
HIF-1 Alpha, VEGF and MMP-8 Levels in PICF of Smokers Versus Non Smokers

NCT05325918

Sponsor

Future University in Egypt

Status

Completed

Last Update Posted

Apr 14, 2022Actual

Enrollment

14Actual

Phase

Not provided

Conditions

Peri-Implantitis

Interventions

Not provided

Countries

Egypt

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

Apr 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 29, 2021Actual

Primary Completion Date

Jan 15, 2022Actual

Completion Date

Jan 30, 2022Actual

First Submitted Date

Apr 6, 2022

First Submission Date that Met QC Criteria

Apr 6, 2022

First Posted Date

Apr 13, 2022Actual

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

Apr 13, 2022

Last Update Posted Date

Apr 14, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sarah Elkot, Lecturer of Oral Medicine, Periodontology and Diagnosis, Faculty of Oral and Dental Medicine, Future University in Egypt, Cairo, Egypt., Future University in EgyptPrincipal Investigator

Lead Sponsor

Future University in EgyptOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Smoking is a major risk factor for developing peri-implantitis so the current study is comparing inflammatory markers in smokers versus non smokers to know if they have a potential role in pathogenesis of peri-implantitis

Detailed Description

Peri -implant crevicular fluid was obtained from seven smoker patients and then compared to peri-implant crevicular fluid from seven non smoker individuals.

The peri-implant crevicular fluid was obtained using periopaper strips then analyzed using ELISA kits of these markers; HIF-1 Alpha, VEGF and MMP-8

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

Retention

Enrollment

14Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measurement of levels of HIF-1 Alpha, VEGF and MMP-8 in peri-implant crevicular fluid	Markers collected using periopaper strips	Baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Medically free patients
Individuals with restored implants placed one year or more before study enrollment
Both genders
Age range 20-50 years old

Exclusion Criteria:

Pregnant Females
Lactating females

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Smoker patients with restored implants

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sarah M Elkot, Lecturer	Lecturer of Oral Medicine and Periodontology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of oral and dental medicine,FUE, Cairo,Egypt		Cairo		11835	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D057873	Peri-Implantitis
D012907	Smoking
D007249	Inflammation

Ancestor Terms

ID	Term
D010510	Periodontal Diseases
D009059	Mouth Diseases
D009057	Stomatognathic Diseases
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided