NCT07628803

Brief Summary

This cross-sectional observational study aims to evaluate the relationship between periodontal inflammation severity and the Pan-Immune-Inflammation Value (PIV) in systemically healthy adults. A total of 160 participants will be recruited from the Department of Periodontology, Faculty of Dentistry, Bolu Abant Izzet Baysal University. Clinical periodontal parameters and Periodontal Inflamed Surface Area (PISA) will be recorded, and their association with PIV calculated from complete blood count parameters will be analyzed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2025

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2026

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

May 22, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 5, 2026

Completed
Last Updated

June 5, 2026

Status Verified

June 1, 2026

Enrollment Period

5 months

First QC Date

May 22, 2026

Last Update Submit

June 1, 2026

Conditions

Keywords

Periodontal Inflamed Surface AreaPISAPan-Immune-Inflammation ValuePIVSystemic InflammationComplete Blood CountPeriodontal Disease

Outcome Measures

Primary Outcomes (1)

  • Correlation between Periodontal Inflamed Surface Area and Pan-Immune-Inflammation Value

    The correlation between Periodontal Inflamed Surface Area and Pan-Immune-Inflammation Value will be evaluated. Periodontal Inflamed Surface Area will be calculated using periodontal clinical measurements, including probing pocket depth, gingival recession, and bleeding on probing, and will be expressed in square millimeters. Pan-Immune-Inflammation Value will be calculated from complete blood count parameters using the formula: neutrophil count × platelet count × monocyte count / lymphocyte count.Correlation coefficient between Periodontal Inflamed Surface Area and Pan-Immune-Inflammation Value.

    Baseline (single visit)

Secondary Outcomes (5)

  • Correlation between Periodontal Inflamed Surface Area and Systemic Immune-Inflammation Index

    Baseline (single visit)

  • Correlation between Periodontal Inflamed Surface Area and Systemic Inflammation Response Index

    Baseline (single visit)

  • Periodontal Inflamed Surface Area

    Baseline, single visit.

  • Systemic Immune-Inflammation Index

    Baseline, single visit.

  • Systemic Inflammation Response Index

    Baseline, single visit.

Study Arms (3)

Periodontitis

Systemically healthy individuals diagnosed with Stage III or Stage IV periodontitis according to the 2017 World Workshop Classification of Periodontal and Peri-Implant Diseases and Conditions.

Gingivitis

Systemically healthy individuals with gingival inflammation without clinical attachment loss consistent with periodontitis.

Periodontally Healthy

Systemically healthy individuals with clinically healthy periodontal tissues and no evidence of periodontitis.

Eligibility Criteria

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

Systemically healthy adults aged 18 years and older who present to the Department of Periodontology, Faculty of Dentistry, Bolu Abant Izzet Baysal University, and who are diagnosed as periodontally healthy, having gingivitis, or having Stage III-IV periodontitis according to the 2017 World Workshop Classification of Periodontal and Peri-Implant Diseases and Conditions.

You may qualify if:

  • Age 18 years and older
  • Systemically healthy individuals
  • Complete blood count performed within the previous 3 months
  • Diagnosis of periodontal health, gingivitis, or Stage III-IV periodontitis according to the 2017 World Workshop Classification of Periodontal and Peri-Implant Diseases and Conditions
  • Willingness to provide written informed consent

You may not qualify if:

  • Pregnancy or lactation- History of systemic diseases that may affect periodontal tissues
  • Use of antibiotics or anti-inflammatory drugs within the previous 3 months
  • Periodontal treatment within the previous 6 months
  • Presence of infectious diseases such as HIV, hepatitis B, or tuberculosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Bolu Abant İzzet Baysal University, Department of Periodontics

Bolu, Central, 14100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

PeriodontitisGingivitisPeriodontal Diseases

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesInfectionsGingival Diseases

Study Design

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

Study Record Dates

First Submitted

May 22, 2026

First Posted

June 5, 2026

Study Start

December 15, 2025

Primary Completion

May 15, 2026

Study Completion

May 15, 2026

Last Updated

June 5, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be publicly shared to protect participant confidentiality. De-identified and aggregated data may be available from the corresponding author upon reasonable request.

Locations