- ICH GCP
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- Klinische Studie NCT07628803
Relationship Between Periodontal Inflammation Severity and Pan-Immune System Inflammation Value
Evaluatıon Of The Relatıonshıp Between Perıodontal Inflammatıon Severıty And Pan-Immune System Inflammatıon Value
Studienübersicht
Status
Bedingungen
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
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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Central
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Bolu, Central, Türkei (türkiye), 14100
- Faculty of Dentistry, Bolu Abant İzzet Baysal University, Department of Periodontics
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
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
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
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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.
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Gingivitis
Systemically healthy individuals with gingival inflammation without clinical attachment loss consistent with periodontitis.
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Periodontally Healthy
Systemically healthy individuals with clinically healthy periodontal tissues and no evidence of periodontitis.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Correlation between Periodontal Inflamed Surface Area and Pan-Immune-Inflammation Value
Zeitfenster: Baseline (single visit)
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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.
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Baseline (single visit)
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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.
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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.
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Baseline (single visit)
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Periodontal Inflamed Surface Area
Zeitfenster: Baseline, single visit.
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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.
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Baseline, single visit.
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Systemic Immune-Inflammation Index
Zeitfenster: Baseline, single visit.
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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.
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Baseline, single visit.
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Systemic Inflammation Response Index
Zeitfenster: Baseline, single visit.
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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.
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Baseline, single visit.
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Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- BAİBU-Perio-ZA-01
Plan für individuelle Teilnehmerdaten (IPD)
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Beschreibung des IPD-Plans
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Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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