NCT05506098

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2019

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

August 16, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 18, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2022

Completed
Last Updated

January 30, 2023

Status Verified

January 1, 2023

Enrollment Period

3.6 years

First QC Date

August 16, 2022

Last Update Submit

January 26, 2023

Conditions

Periodontitis

Keywords

periodontitis, STAT3

Outcome Measures

Primary Outcomes (1)

  • STAT3 detection in gingival tissues

    Detection of STAT3 in gingival tissues

    1 day

Study Arms (2)

Healthy

Subjects without periodontitis

Other: no intervention

Periodontitis

Subjects with periodontitis

Other: no intervention

Interventions

no interventionOTHER

no intervention

HealthyPeriodontitis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Female and male adults living in Santiago, Chile.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, University of Chile

Santiago, Chile

Location

Biospecimen

Retention: SAMPLES WITH DNA

gingival biopsies

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 16, 2022

First Posted

August 18, 2022

Study Start

March 20, 2019

Primary Completion

October 20, 2022

Study Completion

October 20, 2022

Last Updated

January 30, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, CSR, ANALYTIC CODE
Time Frame
december 2022

Locations

CL(1)