NCT05924828

Brief Summary

The goal of this observational study is to compare saliva sTREM-1, sTREM-2, Presepsin levels and sTREM-1/sTREM-2 ratio of participants with/without periodontitis. The main question it aims to answer is there a relationship between saliva sTREM-1, sTREM-2, Presepsin levels, sTREM-1/sTREM-2 ratio and periodontitis. Participants will give saliva samples without any intervention

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2023

Shorter than P25 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

First Submitted

Initial submission to the registry

June 21, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 29, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

January 30, 2024

Status Verified

January 1, 2024

Enrollment Period

2 months

First QC Date

June 21, 2023

Last Update Submit

January 29, 2024

Conditions

Keywords

periodontitissTREM-1sTREM-2Presepsin

Outcome Measures

Primary Outcomes (1)

  • sTREM-1, sTREM-2, Presepsin

    sTREM-1, sTREM-2, Presepsin levels in saliva

    0-1 hours of the diagnosis

Study Arms (2)

Healthy

participants without periodontitis

Other: no intervention

periodontitis

participants with stage-3 periodontitis

Other: no intervention

Interventions

no intervention

Also known as: periodontitis, healthy
Healthyperiodontitis

Eligibility Criteria

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

individuals who referred to Atatürk University, Department of Periodontology

You may qualify if:

  • Individuals should not have any systemic disease that may or may not require medication, including salivary gland pathologies, and not particularly thyroid organ pathologies.
  • Individuals have not been continuously treated with anti-inflammatory, antioxidant or similar drugs in the last 6 months,
  • Individuals have not received periodontal treatment until 6 months ago,
  • Individuals must have at least 14 teeth
  • Patients diagnosed with stage 3 periodontitis

You may not qualify if:

  • Having a systemic disease such as cardiovascular, diabetes, hypertension, thyroid organ pathologies, chronic kidney failure
  • Being pregnant/breastfeeding
  • Being on medication for any reason
  • Being a smoker/tobacco user
  • Having another periodontal disease other than periodontitis
  • Having a chronic inflammatory disease (COPD, asthma)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atatürk University

Erzurum, 25240_, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

saliva

MeSH Terms

Conditions

Periodontal DiseasesPeriodontitis

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Officials

  • DİDEM ÖZKAL EMİNOĞLU

    Ataturk University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

June 21, 2023

First Posted

June 29, 2023

Study Start

August 1, 2023

Primary Completion

October 1, 2023

Study Completion

December 1, 2023

Last Updated

January 30, 2024

Record last verified: 2024-01

Locations