Effect of Non Surgical Periodontal Therapy on Inflammator... | NCT05295576

Studies
Effect of Non Surgical Periodontal Therapy on Inflammatory Markers in Chronic Periodontitis Patients

NCT05295576

Sponsor

Future University in Egypt

Status

Completed

Last Update Posted

Mar 25, 2022Actual

Enrollment

50Actual

Phase

Not provided

Conditions

Aggressive Periodontitis

Interventions

non surgical periodontal therapy

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

Mar 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

Mar 27, 2021Actual

Primary Completion Date

Dec 15, 2021Actual

Completion Date

Dec 30, 2021Actual

First Submitted Date

Mar 6, 2022

First Submission Date that Met QC Criteria

Mar 16, 2022

First Posted Date

Mar 25, 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

Mar 16, 2022

Last Update Posted Date

Mar 25, 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)

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

The current study was performed to study levels of Il-17 and Il-18 in aggressive periodontitis patients before and after non surgical periodontal therapy

Detailed Description

Background:host defense factors are involved in pathogenesis of chronic periodontitis so, the current study is assessing levels of Il-17 and Il-18 in chronic periodontitis patients versus periodontally healthy controls.

Subjects and methods: Fifty subjects were included; twenty five of them are diagnosed with chronic periodontitis patients and twenty five are periodontally healthy subjects. Probing depth (PD), clinical attachment level (CAL), plaque index (PI) and gingival index (GI) were recorded for all the enrolled subjects. GCF levels of Il-17 and IL-18 were analyzed by enzyme-linked immunosorbent assay (ELISA).

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

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
chronic periodontitis		scaling and root planing	Procedure: non surgical periodontal therapy
Periodontally healthy individuals		no treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
non surgical periodontal therapy	Procedure	Scaling and root planing	chronic periodontitis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
measure levels of Il-17 and Il-18 in chronic periodontitis patients	measure levels of Il-17 and Il-18 in GCF of chronic periodontitis patients	Change from Baseline Il-17 andIl-18 at 3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Medically free subjects .
both genders .
age range between 30 to 60 years old .

Exclusion Criteria:

Subjects with periodontal surgeries in the last 6 months.
Subjects with prior use of antibiotics in the last 6 months.
Smokers.
Pregnant and lactating females were excluded.
Lactating females.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Chronic periodontitis patients

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
Future university in 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
D010520	Aggressive Periodontitis

Ancestor Terms

ID	Term
D010518	Periodontitis
D010510	Periodontal Diseases
D009059	Mouth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided