Serum Ferritin and Hepicidin Concentration in Chronic Per... | NCT03964428

Studies
Serum Ferritin and Hepicidin Concentration in Chronic Periodontitis Patients With T2DM

NCT03964428

Sponsor

Fayoum University

Status

Completed

Last Update Posted

Jun 11, 2019Actual

Enrollment

60Actual

Phase

Not provided

Conditions

Periodontitis
Type2 Diabetes

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

Jun 2019

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

Sep 1, 2018Actual

Primary Completion Date

Jan 30, 2019Actual

Completion Date

Jan 30, 2019Actual

First Submitted Date

May 23, 2019

First Submission Date that Met QC Criteria

May 24, 2019

First Posted Date

May 28, 2019Actual

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

Jun 8, 2019

Last Update Posted Date

Jun 11, 2019Actual

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

serum level of ferritin and hepicidin were evaluated in periodontitis patient with and without type 2 diabetes before and after non surgical periodontal treatment to clarify their in periodontal disease

Detailed Description

Not provided

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

60Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
ferritin concentration	ng/ml	0-3 months
hepicidin concentration	ng/ml	0-3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with more than 30% of the sites had clinical attachment level (CAL) 3-4mm with T2DM
systemically healthy patients with more than 30% of the sites had clinical attachment level (CAL) 3-4mm
healthy subjects had clinically healthy gingiva with ≤ 3mm pocket probing depth (PPD), nearly zero plaque index (PI), gingival index (GI), zero CAL.

Exclusion Criteria:

(I) Pregnancy or lactation, (II) History of receiving professional periodontal treatment during the past 6 months; (III) Treatment with any type of medications and/ or antibiotics during the past 3 months and (IV) Current or former smokers.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

participants were collected from the Outpatient Clinic, Department of Oral Medicine, Periodontology and Diagnosis, and the restorative clinic for the control subjects, Faculty of Oral and Dental Medicine, fayoum University

Sampling Method

Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D010518	Periodontitis
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D010510	Periodontal Diseases
D009059	Mouth Diseases
D009057	Stomatognathic Diseases
D003920	Diabetes Mellitus

Browse Leaves

Not provided

Browse Branches

Not provided