Investigation of the Relationship Between Periodontitis and Alzheimer's Disease in Terms of Blood Parameters

NCT ID: NCT07069244

Last Updated: 2025-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-05

Study Completion Date

2025-11-03

Brief Summary

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The aim of this study was to analyse the possible relationship between periodontal inflammation and Alzheimer's disease and to investigate the role of blood parameters in this relationship.

Detailed Description

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This retrospective case-control study will include individuals who were clinically and radiographically examined, diagnosed with periodontal disease, read and signed informed consent forms between March 2022 and July 2025 at the Periodontology Departments of Bezmialem Vakif University, Uskudar University and Bolu Abant Izzet Baysal University Faculty of Dentistry.

In this study, two groups will be formed as a case group consisting of individuals with periodontitis diagnosed with probable Alzheimer's disease according to NINCDS-ADRDA and DSM-V diagnostic criteria and a control group consisting of individuals with periodontitis only.

Patients who underwent periodontal evaluations at six sites per tooth, with the following parameters recorded-plaque percentage, probing pocket depth, percentage of bleeding on probing, clinical attachment level, number of teeth, and periodontal inflamed surface area (PISA)-will be included in the study.

Compliance with the inclusion and exclusion criteria will be verified through patient files and digital records. In individuals with a probable diagnosis of Alzheimer's disease according to NINCDS-ADRDA and DSM-V diagnostic criteria, disease stage as determined by the Clinical Dementia Rating scale and Standardized Mini-Mental Test (SMMT) scores will also be recorded.

Hematological data will be obtained from patients' recorded complete blood count test results and the following parameters will be utilized:

* White blood cell count, neutrophil, lymphocyte, monocyte, eosinophil, basophil counts and percentages, neutrophil/lymphocyte ratio (NLR), monocyte/lymphocyte ratio (MLR)
* Platelet count, platelet/lymphocyte ratio (PLR), platelet distribution width (PDW), mean platelet volume (MPV), plateletcrit (PCT)
* Erythrocyte count, hemoglobin (HGB), hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular haemoglobin (MCH), mean corpuscular haemoglobin concentration (MCHC), red blood cell distribution width (RDW)
* In addition, inflammation indicators such as pan-immune inflammation value (PIV), systemic immune-inflammation index (SII) and hemoglobin/erythrocyte ratio (HRR), which are formulated from the above parameters, will also be recorded.

Conditions

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Periodontal Inflammation Biomarkers / Blood Blood Cell Count Alzheimer Disease Periodontal Disease Periodontitis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Case group

Periodontitis with Alzheimer's disease

Complete Blood Count Test

Intervention Type DIAGNOSTIC_TEST

Complete blood count test provides data on total white blood cell count, neutrophil count, neutrophil percentage, lymphocyte count, lymphocyte percentage, monocyte count, monocyte percentage, eosinophil count, eosinophil percentage, basophil count, basophil percentage, platelet count, platelet distribution width (PDW), mean platelet volume (MPV), plateletcrit (PCT), erythrocyte count, hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC) and red blood cell distribution width (RDW). In addition, neutrophil-lymphocyte ratio (NLR), monocyte-lymphocyte ratio (MLR), platelet-leukocyte ratio (PLR), Pan-Immune-Inflammation Value (PIV), Systemic Immune-Inflammation Index (SII), Hemoglobin-to-Red Cell Distribution Width Ratio (HRR) values are also formulated from these parameters.

Periodontal examinations

Intervention Type DIAGNOSTIC_TEST

With periodontal evaluation, plaque percentage, probing pocket depth, percentage of bleeding on probing, clinical attachment level, number of teeth, periodontal inflammatory surface area (PISA) parameters are recorded.

Clinical Dementia Rating scale

Intervention Type DIAGNOSTIC_TEST

Stage I: mild Alzheimer's disease, Stage II: moderate Alzheimer's disease, Stage III: severe Alzheimer's disease

Standardized Mini-Mental Test

Intervention Type DIAGNOSTIC_TEST

Cognitive status is assessed with the Standardized Mini-Mental Test.

Control group

Periodontitis without Alzheimer's disease

Complete Blood Count Test

Intervention Type DIAGNOSTIC_TEST

Complete blood count test provides data on total white blood cell count, neutrophil count, neutrophil percentage, lymphocyte count, lymphocyte percentage, monocyte count, monocyte percentage, eosinophil count, eosinophil percentage, basophil count, basophil percentage, platelet count, platelet distribution width (PDW), mean platelet volume (MPV), plateletcrit (PCT), erythrocyte count, hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC) and red blood cell distribution width (RDW). In addition, neutrophil-lymphocyte ratio (NLR), monocyte-lymphocyte ratio (MLR), platelet-leukocyte ratio (PLR), Pan-Immune-Inflammation Value (PIV), Systemic Immune-Inflammation Index (SII), Hemoglobin-to-Red Cell Distribution Width Ratio (HRR) values are also formulated from these parameters.

Periodontal examinations

Intervention Type DIAGNOSTIC_TEST

With periodontal evaluation, plaque percentage, probing pocket depth, percentage of bleeding on probing, clinical attachment level, number of teeth, periodontal inflammatory surface area (PISA) parameters are recorded.

Interventions

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Complete Blood Count Test

Complete blood count test provides data on total white blood cell count, neutrophil count, neutrophil percentage, lymphocyte count, lymphocyte percentage, monocyte count, monocyte percentage, eosinophil count, eosinophil percentage, basophil count, basophil percentage, platelet count, platelet distribution width (PDW), mean platelet volume (MPV), plateletcrit (PCT), erythrocyte count, hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC) and red blood cell distribution width (RDW). In addition, neutrophil-lymphocyte ratio (NLR), monocyte-lymphocyte ratio (MLR), platelet-leukocyte ratio (PLR), Pan-Immune-Inflammation Value (PIV), Systemic Immune-Inflammation Index (SII), Hemoglobin-to-Red Cell Distribution Width Ratio (HRR) values are also formulated from these parameters.

Intervention Type DIAGNOSTIC_TEST

Periodontal examinations

With periodontal evaluation, plaque percentage, probing pocket depth, percentage of bleeding on probing, clinical attachment level, number of teeth, periodontal inflammatory surface area (PISA) parameters are recorded.

Intervention Type DIAGNOSTIC_TEST

Clinical Dementia Rating scale

Stage I: mild Alzheimer's disease, Stage II: moderate Alzheimer's disease, Stage III: severe Alzheimer's disease

Intervention Type DIAGNOSTIC_TEST

Standardized Mini-Mental Test

Cognitive status is assessed with the Standardized Mini-Mental Test.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Between March 2022 and July 2025, those who applied to the Periodontics Departments of the Dentistry Faculties of Uskudar University, Bezmialem Vakif University and Bolu Abant Izzet Baysal University,
* Informed consent form was obtained during the examination,
* Over 50 years of age,
* Non-smoker and non-alcoholic,
* No psychiatric disorders affecting cognitive status and no medication affecting cognitive status,
* Complete blood count was performed within the 6 months prior to the date of inclusion in the study,
* No dental treatment within the last 1 year,
* Periodontal examination was performed by expert periodontologists who calibrated the inter- and intra-examination,
* Individuals diagnosed with periodontitis as a result of periodontal examination and radiographic examination, and
* For individuals diagnosed with Alzheimer's disease: Recording their stage according to the Clinical Dementia Rating (CDR) and Standardized Mini-Mental Test (SMMT) scores

Exclusion Criteria

* Individuals with fewer than 10 teeth,
* Individuals with uncontrolled systemic disease,
* Individuals who regularly use anti-inflammatories or corticosteroids
Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Uskudar University

OTHER

Sponsor Role lead

Responsible Party

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Kubra Karaduran

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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OZLEM GELISIN

Role: STUDY_CHAIR

Dr. Sadi Konuk Training and Research Hospital

AHMET AYDOGDU

Role: STUDY_CHAIR

Istanbul Galata University

SADIYE GUNPINAR

Role: STUDY_CHAIR

Bezmialem Vakif University

ZEYNEP AKGUL

Role: STUDY_CHAIR

Abant Izzet Baysal University

KUBRA KARADURAN

Role: PRINCIPAL_INVESTIGATOR

Uskudar University

Locations

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Bolu Abant Izzet Baysal University

Bolu, , Turkey (Türkiye)

Site Status

Bezmialem Vakif University

Istanbul, , Turkey (Türkiye)

Site Status

Uskudar University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Wang RH, Wen WX, Jiang ZP, Du ZP, Ma ZH, Lu AL, Li HP, Yuan F, Wu SB, Guo JW, Cai YF, Huang Y, Wang LX, Lu HJ. The clinical value of neutrophil-to-lymphocyte ratio (NLR), systemic immune-inflammation index (SII), platelet-to-lymphocyte ratio (PLR) and systemic inflammation response index (SIRI) for predicting the occurrence and severity of pneumonia in patients with intracerebral hemorrhage. Front Immunol. 2023 Feb 13;14:1115031. doi: 10.3389/fimmu.2023.1115031. eCollection 2023.

Reference Type BACKGROUND
PMID: 36860868 (View on PubMed)

An P, Zhou X, Du Y, Zhao J, Song A, Liu H, Ma F, Huang G. Association of Neutrophil-Lymphocyte Ratio with Mild Cognitive Impairment in Elderly Chinese Adults: A Case-control Study. Curr Alzheimer Res. 2019;16(14):1309-1315. doi: 10.2174/1567205017666200103110521.

Reference Type BACKGROUND
PMID: 31902361 (View on PubMed)

Zhou C, Liu Y, Bai J, Luo Y, Song J, Feng P. Mean platelet volume is associated with periodontitis: a cross-sectional study. BMC Oral Health. 2024 Apr 16;24(1):461. doi: 10.1186/s12903-024-04223-8.

Reference Type BACKGROUND
PMID: 38627719 (View on PubMed)

Leira Y, Carballo A, Orlandi M, Aldrey JM, Pias-Peleteiro JM, Moreno F, Vazquez-Vazquez L, Campos F, D'Aiuto F, Castillo J, Sobrino T, Blanco J. Periodontitis and systemic markers of neurodegeneration: A case-control study. J Clin Periodontol. 2020 May;47(5):561-571. doi: 10.1111/jcpe.13267. Epub 2020 Mar 12.

Reference Type BACKGROUND
PMID: 32027386 (View on PubMed)

Tosatti JAG, Pereira JD, Loures CMG, Fraga VG, Magalhaes CA, Eugenio RDAC, Guimaraes HC, Resende EPF, de Souza LC, Carvalho MDG, Caramelli P, Gomes KB. Complete blood count and systemic inflammation indices in individuals with Alzheimer's disease: A case-control study. J Clin Neurosci. 2025 Feb;132:111011. doi: 10.1016/j.jocn.2024.111011. Epub 2024 Dec 28.

Reference Type BACKGROUND
PMID: 39733506 (View on PubMed)

Other Identifiers

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KKARADURAN

Identifier Type: -

Identifier Source: org_study_id

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