Relationship Between Periodontal Inflammation Severity and Pan-Immune System Inflammation Value

June 1, 2026 updated by: Zeynep AKGÜL, Abant Izzet Baysal University

Evaluatıon Of The Relatıonshıp Between Perıodontal Inflammatıon Severıty And Pan-Immune System Inflammatıon Value

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.

Study Overview

Status

Completed

Conditions

Detailed Description

Periodontitis is a chronic inflammatory disease that leads to progressive destruction of the tooth-supporting tissues and contributes to systemic inflammatory burden. Periodontal Inflamed Surface Area (PISA) is a validated quantitative measure that estimates the total inflamed periodontal surface area and reflects the inflammatory burden associated with periodontal disease.

The Pan-Immune-Inflammation Value (PIV) is a novel composite biomarker calculated from complete blood count parameters using the following formula: neutrophil count × platelet count × monocyte count / lymphocyte count. PIV has been proposed as a comprehensive indicator of systemic inflammation.

This cross-sectional observational study aims to investigate the relationship between PISA and PIV in systemically healthy adults.

A total of 160 participants aged 18 years and older will be recruited from the Department of Periodontology, Faculty of Dentistry, Bolu Abant Izzet Baysal University. Participants will be classified as periodontally healthy, gingivitis, or periodontitis according to the 2017 World Workshop Classification of Periodontal and Peri-Implant Diseases and Conditions.

Clinical periodontal parameters, including Plaque Index, Gingival Index, Papillary Bleeding Index, Probing Pocket Depth, Clinical Attachment Loss, Bleeding on Probing, and PISA, will be recorded by a single calibrated examiner.

Complete blood count results obtained within the previous three months will be used to calculate PIV.

The primary objective is to evaluate the association between PISA and PIV. Secondary objectives include assessing the relationships between PIV and other periodontal clinical parameters.

An a priori power analysis performed using G*Power indicated that at least 84 participants were required to detect a moderate correlation (r = 0.30) with 80% power at a significance level of 0.05. To allow subgroup analyses and potential exclusions, 160 participants will be enrolled.

Statistical analyses will be conducted using SPSS software, and statistical significance will be set at p < 0.05.

Study Type

Observational

Enrollment (Actual)

160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Central
      • Bolu, Central, Turkey (Türkiye), 14100
        • Faculty of Dentistry, Bolu Abant İzzet Baysal University, Department of Periodontics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between Periodontal Inflamed Surface Area and Pan-Immune-Inflammation Value
Time Frame: Baseline (single visit)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between Periodontal Inflamed Surface Area and Systemic Immune-Inflammation Index
Time Frame: Baseline (single visit)
The correlation between Periodontal Inflamed Surface Area and Systemic Immune-Inflammation Index 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. Systemic Immune-Inflammation Index will be calculated from complete blood count parameters using the formula: platelet count × neutrophil count / lymphocyte count.
Baseline (single visit)
Correlation between Periodontal Inflamed Surface Area and Systemic Inflammation Response Index
Time Frame: Baseline (single visit)
The correlation between Periodontal Inflamed Surface Area and Systemic Inflammation Response Index 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. Systemic Inflammation Response Index will be calculated from complete blood count parameters using the formula: neutrophil count × monocyte count / lymphocyte count.Correlation coefficient between Periodontal Inflamed Surface Area and Systemic Inflammation Response Index.
Baseline (single visit)
Periodontal Inflamed Surface Area
Time Frame: Baseline, single visit.
Periodontal Inflamed Surface Area will be calculated using periodontal clinical measurements, including probing pocket depth, gingival recession, and bleeding on probing. The value will represent the total inflamed periodontal surface area and will be expressed in square millimeters.Periodontal Inflamed Surface Area in square millimeters.
Baseline, single visit.
Systemic Immune-Inflammation Index
Time Frame: Baseline, single visit.
Systemic Immune-Inflammation Index will be calculated from complete blood count parameters using the formula: platelet count × neutrophil count / lymphocyte count. This value will be used as a systemic inflammatory index.Systemic Immune-Inflammation Index calculated from complete blood count parameters.
Baseline, single visit.
Systemic Inflammation Response Index
Time Frame: Baseline, single visit.
Systemic Inflammation Response Index will be calculated from complete blood count parameters using the formula: neutrophil count × monocyte count / lymphocyte count. This value will be used as a systemic inflammatory index.
Baseline, single visit.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abant Izzet Baysal University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2025

Primary Completion (Actual)

May 15, 2026

Study Completion (Actual)

May 15, 2026

Study Registration Dates

First Submitted

May 22, 2026

First Submitted That Met QC Criteria

June 1, 2026

First Posted (Actual)

June 5, 2026

Study Record Updates

Last Update Posted (Actual)

June 5, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BAİBU-Perio-ZA-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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