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

1. Juni 2026 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

160

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Ja

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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.

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Correlation between Periodontal Inflamed Surface Area and Pan-Immune-Inflammation Value
Zeitfenster: 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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Correlation between Periodontal Inflamed Surface Area and Systemic Immune-Inflammation Index
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

15. Dezember 2025

Primärer Abschluss (Tatsächlich)

15. Mai 2026

Studienabschluss (Tatsächlich)

15. Mai 2026

Studienanmeldedaten

Zuerst eingereicht

22. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

1. Juni 2026

Zuerst gepostet (Tatsächlich)

5. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

5. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

1. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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