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Periodontal DiseaseNCT07069244

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

An observational study of Periodontal Disease and Periodontitis, run by Uskudar University at 3 sites in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 50 to 90 years
What is being tested?
Complete Blood Count Test, Periodontal examinations and Clinical Dementia Rating scale
How many people
100 participants
Where
3 sitesTurkey (Türkiye)
Study dates
5 Aug 2025to 3 Nov 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Individuals with periodontitis with Alzheimer's disease (Case group), Individuals with periodontitis without Alzheimer's disease (Control group)

Who may be able to join

  • 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,
Show all 10Show fewer
  • 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

Who cannot join

  • Individuals with fewer than 10 teeth,
  • Individuals with uncontrolled systemic disease,
  • Individuals who regularly use anti-inflammatories or corticosteroids

Trial locations and contacts

3 sites in 1 country.

Turkey (Türkiye)3 sites
  • Bolu Abant Izzet Baysal University

    Bolu

  • Bezmialem Vakif University

    Istanbul

  • Uskudar University

    Istanbul

Other trials in Turkey (Türkiye)

About this study

Official title: Blood Markers in Periodontal Inflammation and Alzheimer's Disease: A Retrospective Case-Control Study

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.

Read the detailed description

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.
Being tested
Complete Blood Count Test, Periodontal examinations, Clinical Dementia Rating scale, Standardized Mini-Mental Test
Keywords
Alzheimer disease, biomarkers, blood cell count, complete blood count, periodontal disease, periodontitis
Medical subject headings
Periodontal Diseases, Periodontitis, Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Complete Blood Count TestDiagnostic 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 examinationsDiagnostic 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 scaleDiagnostic test

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

  • Standardized Mini-Mental TestDiagnostic test

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

Study groups in NCT07069244
Study groupRoleWhat they receive
Case groupPeriodontitis with Alzheimer's disease
Receives: Diagnostic Test: Complete Blood Count Test; Diagnostic Test: Periodontal examinations; Diagnostic Test: Clinical Dementia Rating scale; Diagnostic Test: Standardized Mini-Mental Test
Control groupPeriodontitis without Alzheimer's disease
Receives: Diagnostic Test: Complete Blood Count Test; Diagnostic Test: Periodontal examinations

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Probing pocket depth

    Measurement of the depth of a sulcus or periodontal pocket determined by measuring distance from a gingival margin to the base of the sulcus or pocket with a calibrated periodontal probe.

    Measured: Baseline

  2. Bleeding on probing (BOP)

    The number obtained by dividing the sum of the positive areas by the sum of the examined areas is multiplied by 100 and the value obtained is expressed as the percentage of bleeding at probing (BOP%).

    Measured: Baseline

  3. Periodontal inflammatory surface area (PISA)

    It is the calculation of the area of ulcerated periodontal pockets showing bleeding on probing based on the periodontal epithelial surface area.

    Measured: Baseline

Secondary outcomes (33)
  1. Clinical attachment level

    Clinical attachment level (CAL) is a more reliable indicator of periodontal support around a tooth than probing depth alone, as it is measured from a fixed anatomical landmark-the cementoenamel junction (CEJ)-which remains constant over time.

    Calculating CAL requires two measurements: the distance from the gingival margin to the CEJ and the probing depth.

    In cases of gingival recession, CAL is calculated by adding the probing depth to the distance from the gingival margin to the CEJ.

    In cases of gingival overgrowth, CAL is determined by subtracting the distance from the gingival margin to the CEJ from the probing depth.

    Measured: Baseline

  2. Plaque percentage

    The presence or absence of plaque is determinant, recorded as (+) in the presence of plaque or (-) in the absence of plaque, and the percentage of the entire mouth affected by plaque is expressed as a percentage (P%).

    Measured: Baseline

  3. Number of teeth

    Recording the number of teeth present

    Measured: Baseline

  4. White blood cell count

    White blood cell (WBC) count measures the total number of leukocytes in peripheral blood, usually expressed as cells per microliter (cells/µL). WBC is essential for evaluating immune status, infections, and inflammatory conditions.

    Measured: Between baseline and -6th month

  5. Neutrophil count

    Neutrophil count measures the absolute number of neutrophils in peripheral blood, typically expressed as cells per microliter (cells/µL). Neutrophils play a critical role in innate immune defense, especially against bacterial infections.

    Measured: Between baseline and -6th month

  6. Lymphocyte count

    Lymphocyte count measures the absolute number of lymphocytes in peripheral blood, typically expressed as cells per microliter (cells/µL). Lymphocytes are essential for adaptive immune responses and immune memory.

    Measured: Between baseline and -6th month

  7. Monocyte count

    Monocyte count measures the absolute number of monocytes in peripheral blood, typically expressed as cells per microliter (cells/µL). Monocytes are key cells in immune response, inflammation, and tissue repair.

    Measured: Between baseline and -6th month

  8. Eosinophil count

    Eosinophil count measures the absolute number of eosinophils in peripheral blood, typically expressed as cells per microliter (cells/µL). Eosinophils are involved in allergic responses and parasitic infections.

    Measured: Between baseline and -6th month

  9. Basophil count

    Basophil count measures the absolute number of basophils in peripheral blood, usually expressed as cells per microliter (cells/µL). Basophils are involved in allergic and inflammatory responses.

    Measured: Between baseline and -6th month

  10. Percentage of neutrophils

    The percentage of neutrophils represents the proportion of neutrophils among total white blood cells, expressed as a percentage (%). Neutrophils are key players in innate immune response and bacterial defense.

    Measured: Between baseline and -6th month

  11. Percentage of lymphocytes

    The percentage of lymphocytes indicates the proportion of lymphocytes among total white blood cells, expressed as a percentage (%). Lymphocytes are essential for adaptive immune responses.

    Measured: Between baseline and -6th month

  12. Percentage of monocytes

    The percentage of monocytes represents the proportion of monocytes among total white blood cells, expressed as a percentage (%). Monocytes play a critical role in immune response, inflammation, and tissue repair.

    Measured: Between baseline and -6th month

  13. Percentage of eosinophils

    The percentage of eosinophils indicates the proportion of eosinophils among total white blood cells, expressed as a percentage (%). Eosinophils play key roles in allergic responses and parasitic infections.

    Measured: Between baseline and -6th month

  14. Percentage of basophils

    The percentage of basophils represents the proportion of basophils among total white blood cells, usually expressed as a percentage (%). Basophils are involved in allergic and inflammatory responses.

    Measured: Between baseline and -6th month

  15. Platelet count (PLT)

    Platelet count (PLT) measures the number of platelets in a given volume of blood, expressed in thousands per microliter (×10³/μL). It is essential for assessing clotting function, bleeding disorders, and inflammatory status.

    Measured: Between baseline and -6th month

  16. Platelet distribution width (PDW)

    Platelet Distribution Width (PDW) measures the variability in platelet size, reflecting platelet heterogeneity. It is used to assess platelet activation, production disorders, and systemic inflammatory conditions.

    Measured: Between baseline and -6th month

  17. Mean platelet volume (MPV)

    Mean Platelet Volume (MPV) measures the average size of platelets in the blood and is expressed in femtoliters (fL). It reflects platelet activation and production and is used to assess platelet-related disorders and systemic inflammation.

    Measured: Between baseline and -6th month

  18. Plateletcrit (PCT)

    Plateletcrit (PCT) represents the volume percentage of platelets in the blood and is calculated by multiplying the platelet count by the mean platelet volume. It reflects platelet mass and is used to assess platelet-related disorders and systemic inflammatory status.

    Measured: Between baseline and -6th month

  19. Red blood cell count

    Red blood cell (RBC) count measures the number of erythrocytes in a given volume of blood, typically expressed in million cells per microliter (×10⁶/μL). It is used to assess oxygen transport capacity, anemia, and overall hematologic health.

    Measured: Between baseline and -6th month

  20. Hemoglobin (Hb)

    Hemoglobin is the iron-containing protein in red blood cells responsible for transporting oxygen throughout the body. Hemoglobin concentration is measured in g/dL and is commonly used to assess anemia and systemic health status.

    Measured: Between baseline and -6th month

  21. Hematocrit (HCT)

    Hematocrit (HCT) represents the percentage of whole blood volume occupied by red blood cells. It is used to evaluate oxygen-carrying capacity, anemia status, and hydration level.

    Measured: Between baseline and -6th month

  22. Mean corpuscular volume (MCV)

    Mean Corpuscular Volume (MCV) indicates the average size of red blood cells and is expressed in femtoliters (fL). It is used to classify types of anemia.

    Measured: Between baseline and -6th month

  23. Mean corpuscular hemoglobin (MCH)

    Mean Corpuscular Hemoglobin (MCH) represents the average amount of hemoglobin per red blood cell. It is commonly used to classify types of anemia.

    Measured: Between baseline and -6th month

  24. Mean corpuscular hemoglobin concentration (MCHC)

    Mean Corpuscular Hemoglobin Concentration (MCHC) reflects the average concentration of hemoglobin in red blood cells and is expressed in g/dL. It is used to assess anemia types.

    Measured: Between baseline and -6th month

  25. Red blood cell distribution width (RDW)

    Red Cell Distribution Width (RDW) reflects the variability in size of circulating red blood cells. It is considered a potential marker of inflammation, oxidative stress, and chronic disease burden.

    Measured: Between baseline and -6th month

  26. Neutrophil-to-lymphocyte ratio (NLR)

    The neutrophil-to-lymphocyte ratio (NLR) is calculated by dividing the absolute neutrophil count by the absolute lymphocyte count. It serves as a marker of systemic inflammation and immune system balance

    Measured: Between baseline and -6th month

  27. Monocyte-to-Lymphocyte Ratio (MLR)

    Monocyte-to-Lymphocyte Ratio (MLR) is the ratio of monocyte count to lymphocyte count in peripheral blood. It is used as a marker of systemic inflammation and immune system balance in various diseases.

    Measured: Between baseline and -6th month

  28. Platelet-to-lymphocyte ratio (PLR)

    The platelet-to-lymphocyte ratio (PLR) is a systemic inflammation marker calculated by dividing the absolute platelet count by the absolute lymphocyte count.

    Measured: Between baseline and -6th month

  29. Pan-immune inflammation value (PIV)

    It is a biomarker that evaluates the immune system and inflammation together. PIV= (Neutrophils × Monocytes × Platelets) / Lymphocytes

    Measured: Between baseline and -6th month

  30. Systemic immune-inflammation index (SII)

    It is a parameter reflecting systemic inflammation and immune response. SII= (Neutrophil × Platelet) / Lymphocyte

    Measured: Between baseline and -6th month

  31. Hemoglobin to erythrocyte ratio (HRR)

    It shows the ratio between the haemoglobin level and the distribution width of red blood cells.

    HRR= Hemoglobin / RDW

    Measured: Between baseline and -6th month

  32. Standardized Mini-Mental Test (SMMT)

    The SMMT is used to quantitatively assess cognitive status in Alzheimer's disease patients. The maximum score of the SMMT is 30, of which 10 points correspond to orientation questions, 3 points to recording memory, 5 points to attention and calculation, 3 points to recall and 9 points to language.

    Measured: Baseline

  33. Clinical Dementia Rating Scale

    The Clinical Dementia Rating (CDR) Scale is used to stage different types of dementia, especially Alzheimer-type dementia.

    Stage I: Mild, Satege II: Moderate, Stage III: Severe

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2025
  2. Study start5 Aug 2025
  3. Primary completion3 Oct 2025
  4. Study completion3 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Retrospective
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07069244
Sponsor's protocol ID
KKARADURAN
Status last verified
Nov 2025
First submitted
5 Jul 2025
Last updated
17 Nov 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 36860868
  • 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.

    PubMed 31902361
  • 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.

    PubMed 38627719
  • 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.

    PubMed 32027386
  • 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.

    PubMed 39733506

Questions about this trial

What is this clinical trial studying?

An observational study of Periodontal Disease and Periodontitis, run by Uskudar University at 3 sites in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Probing pocket depth (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07069244, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.

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