Investigating STAT3 as a Driver of Pathology in Periodont... | NCT05506098

Studies
Investigating STAT3 as a Driver of Pathology in Periodontitis

NCT05506098

Sponsor

University of Chile

Status

Completed

Last Update Posted

Jan 30, 2023Actual

Enrollment

28Actual

Phase

Not provided

Conditions

Periodontitis

Interventions

no intervention

Countries

Chile

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

ID	Type	Description	Link
FONDECYT 11180389	Other Grant/Funding Number	AAgencia Nacional de Investigación y Desarrollo (ANID, Chilean Goverment)

Status Module

Record Verification Date

Jan 2023

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 20, 2019Actual

Primary Completion Date

Oct 20, 2022Actual

Completion Date

Oct 20, 2022Actual

First Submitted Date

Aug 16, 2022

First Submission Date that Met QC Criteria

Aug 16, 2022

First Posted Date

Aug 18, 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

Jan 26, 2023

Last Update Posted Date

Jan 30, 2023Actual

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

Periodontitis is a prevalent inflammatory condition that destroys tooth-supporting structures. This condition is associated with pro-inflammatory mediators that utilize STAT3 as an activator of specific genes related to inflammation and tissue destruction. STAT3 has not been studied in the context of periodontitis in humans. We propose that STAT3 is associated with periodontitis. This knowledge might help to further our understanding of periodontitis pathology

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

Retention

Enrollment

28Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Healthy		Subjects without periodontitis	Other: no intervention
Periodontitis		Subjects with periodontitis	Other: no intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
no intervention	Other	no intervention	Healthy Periodontitis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
STAT3 detection in gingival tissues	Detection of STAT3 in gingival tissues	1 day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18-year-old, in good general health, and had no significant medical history.
no history of diabetes or other diseases different than periodontitis.

Exclusion Criteria:

Pregnancy and lactation
Use of antibiotics, immunosuppressive agents, or probiotics within 3 months.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Female and male adults living in Santiago, Chile.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Dentistry, University of Chile		Santiago			Chile

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

All data specified in the informed consent will be shared in publications

Types

Study Protocol
Clinical Study Report (CSR)
Analytic Code

Time Frame

december 2022

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010518	Periodontitis

Ancestor Terms

ID	Term
D010510	Periodontal Diseases
D009059	Mouth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided