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NCT Number: NCT07628803

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Bolu, Central, 14100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Abant Izzet Baysal University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 5, 2026
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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