NCT07069244

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2025

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 5, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 16, 2025

Completed
20 days until next milestone

Study Start

First participant enrolled

August 5, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 3, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 3, 2025

Completed
Last Updated

November 17, 2025

Status Verified

November 1, 2025

Enrollment Period

2 months

First QC Date

July 5, 2025

Last Update Submit

November 13, 2025

Conditions

Keywords

Alzheimer diseasebiomarkersblood cell countcomplete blood countperiodontal diseaseperiodontitis

Outcome Measures

Primary Outcomes (3)

  • 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.

    Baseline

  • 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%).

    Baseline

  • 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.

    Baseline

Secondary Outcomes (33)

  • Clinical attachment level

    Baseline

  • Plaque percentage

    Baseline

  • Number of teeth

    Baseline

  • White blood cell count

    Between baseline and -6th month

  • Neutrophil count

    Between baseline and -6th month

  • +28 more secondary outcomes

Study Arms (2)

Case group

Periodontitis with Alzheimer's disease

Diagnostic Test: Complete Blood Count TestDiagnostic Test: Periodontal examinationsDiagnostic Test: Clinical Dementia Rating scaleDiagnostic Test: Standardized Mini-Mental Test

Control group

Periodontitis without Alzheimer's disease

Diagnostic Test: Complete Blood Count TestDiagnostic Test: Periodontal examinations

Interventions

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.

Case groupControl group

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.

Case groupControl group

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

Case group

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

Case group

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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,
  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Bolu Abant Izzet Baysal University

Bolu, Turkey (Türkiye)

Location

Bezmialem Vakif University

Istanbul, Turkey (Türkiye)

Location

Uskudar University

Istanbul, Turkey (Türkiye)

Location

Related Publications (5)

  • 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.

    PMID: 36860868BACKGROUND
  • 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.

    PMID: 31902361BACKGROUND
  • 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.

    PMID: 38627719BACKGROUND
  • 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.

    PMID: 32027386BACKGROUND
  • 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.

    PMID: 39733506BACKGROUND

MeSH Terms

Conditions

Periodontal DiseasesPeriodontitisAlzheimer Disease

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • OZLEM GELISIN

    Dr. Sadi Konuk Training and Research Hospital

    STUDY CHAIR
  • AHMET AYDOGDU

    Istanbul Galata University

    STUDY CHAIR
  • SADIYE GUNPINAR

    Bezmialem Vakif University

    STUDY CHAIR
  • ZEYNEP AKGUL

    Abant Izzet Baysal University

    STUDY CHAIR
  • KUBRA KARADURAN

    Uskudar University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

July 5, 2025

First Posted

July 16, 2025

Study Start

August 5, 2025

Primary Completion

October 3, 2025

Study Completion

November 3, 2025

Last Updated

November 17, 2025

Record last verified: 2025-11

Locations