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Completed

NCT Number: NCT05807100

Investigation of Alzheimer's Disease and Periodontal Status

The aim of this study is to investigate the effect of the current periodontal status on the progression rate of AD.

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Key information

About this study

Although much is known about its pathogenesis, Alzheimer's disease (AD) is still a terminal disease. For this reason, the correct evaluation and treatment of the risk factors of the disease gains importance in the prevention of the disease. Chronic inflammation, such as periodontal disease, can speed up the onset and progression of AD. The study aimed to investigate the relationship between periodontal status and the rate of progression of dementia in individuals diagnosed with Alzheimer's disease.

In this study, 90 individuals with AD, who were classified as Stage I, Stage II, and Stage III according to the Clinical Dementia Rating Scale. Baseline and 6th month cognitive status assessments of participants who met the inclusion criteria were performed in the Department of Neurology using SMMT. At the 6th month control appointment in the Neurology Department, the participants were referred to the Periodontology Department for oral examinations.

In the Periodontology Department, dental anamnesis of the patients was taken and intraoral examinations were performed. Periodontal examination of all existing teeth of all participants with at least one remaining tooth (excluding third molars) with a Williams-marked periodontal probe (Hu-Friedy, Chicago, Illinois, USA) and all molars and maxillary first premolars with Nabers probe (PQ2N, Hu-Friedy, Chicago, Illinois, USA) was performed and records %P (plak percentage), %BOP (percentage bleeding on probing), CAL (clinical attachment level), PPD (probing pocket depth). The position of the gingival margin and PPD were measured at six sites/teeth (including/excluding third molars). The CAL was then calculated from these measurements. In 2017, periodontal status was determined according to the decisions of the World Workshop on Periodontal and Peri-implant Diseases and Classification of Conditions. The current occlusal relationship status of all patients was evaluated using the Eichner Index and classified as Type 1 (A1-A2-A3-B1) , Type 2 (B2-B3) and Type 3 (B4-C1-C2-C3).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Those who have been diagnosed with probable Alzheimer's disease in the age range of 50-89
  • Do not have dementia other than Alzheimer type dementia.
  • Does not have a psychiatric disorder effecting cognitive status and does not use drugs that effect cognitive status.
  • Those who have other existing systemic diseases (cardiovascular disease, diabetes) under control other than Alzheimer's disease.
  • Not using regular anti-inflammatory and corticosteroids
  • C-Reactive Protein (CRP) value was measured within 6 months prior to the date of inclusion in the study.
  • Non-smoker and no alcohol intake
  • Have not received any dental treatment in the last 1 year
  • In those with less than 10 teeth, the edentulousness was prosthetically rehabilitated.

Exclusion criteria

-

Treatment and study plan

Baseline Standardized Mini Mental Test

Diagnostic Test

Cognitive status assessment was done with Standardized Mini Mental Test.

6th month Standardized Mini Mental Test

Diagnostic Test

Cognitive status assessment was done with Standardized Mini Mental Test.

Other names: Periodontal Examination: Toothed/edentulous condition, occlusal relationship type and periodontal status were evaluated by periodontal examination.

Primary outcomes

  1. Change in Standardized Mini Mental Test (SMMT) score at 6 months

    Time frame: Baseline and 6th month

    The baseline SMMT score was recorded. After 6 months, the 6th month SMMT score was recorded. Change in SMMT score at 6 months= Baseline SMMT score-6th SMMT score.

Secondary outcomes

  1. Alzheimer's disease stage

    Time frame: Baseline

    The stage of Alzheimer's disease was determined according to the clinical dementia rating scale.

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

  2. Gender

    Time frame: Baseline

    The gender distribution of Alzheimer's patients was divided into male and female.

  3. Age

    Time frame: Baseline

    Ages of Alzheimer's patients were determined.

  4. Number of Alzheimer's patient with systemic disease

    Time frame: Baseline

    The current systemic conditions of Alzheimer's patients were evaluated and those with diabetes mellitus and cardiovascular disease were determined.

  5. Presence of periodontal disease

    Time frame: 6th month

    Alzheimer patients were evaluated according to the presence and absence of active periodontal disease.

  6. Plaque percentage (%P)

    Time frame: 6th month

    It is an index that shows the amount of microbial dental plaque on the teeth.

  7. Bleeding on probing percentage (%BOP)

    Time frame: 6th month

    Bleeding that is induced by gentle manipulation of the tissue at the depth of the gingival sulcus.

  8. Periodontal probing depth (PPD) (mm)

    Time frame: 6th month

    The distance from the gingival margin to pocket base.

  9. Clinical attachment level (CAL) (mm)

    Time frame: 6th month

    The clinical attachment level is the distance between the enamel-cementum junction and the gingival sulcus.

  10. Number of teeth

    Time frame: 6th month

    The number of teeth present in Alzheimer's patients was determined.

  11. Occlusal relationship type

    Time frame: 6th month

    Alzheimer's patients were classified according to the Eichner Index (A1-A2-A3-B1-B2-B3-B4-C1-C2-C3). They were evaluated according to their occlusal relationship status and classified as Type 1, Type 2 and Type 3.

    • Type 1: A1-A2-A3-B1
    • Type 2: B2-B3
    • Type 3: B4-C1-C2-C3
  12. C-Reactive Protein (CRP) (mg/l)

    Time frame: between baseline and -6th month

    C-Reactive Protein (CRP) is a protein found in blood plasma whose circulating concentration is associated with inflammation.

  13. Neutrophil ratio (NEUT%)

    Time frame: between baseline and -6th month

    It refers to the percentage of circulating neutrophils to total white blood cells.

  14. Lymphocyte ratio (LYMPH%)

    Time frame: between baseline and -6th month

    It refers to the percentage of circulating lymphocytes to total white blood cells.

  15. Neutrophil count (10*3/uL)

    Time frame: between baseline and -6th month

    It is demonstrates the number of neutrophils in the peripheral blood.

  16. Lymphocyte count (10*3/uL)

    Time frame: between baseline and -6th month

    It is demonstrates the number of lymphocytes in the peripheral blood.

  17. Neutrophil-to-lymphocyte ratio (NLR)

    Time frame: between baseline and -6th month

    Neutrophil-to-lymphocyte ratio (NLR) is calculated by dividing the absolute number of neutrophils by absolute number of lymphocytes.

  18. Mean platelet volume (fL) (MPV)

    Time frame: between baseline and -6th month

    Mean platelet volume (MPW) is a measure of the average size of the platelets.

  19. Platelet distribution width (fL) (PDW)

    Time frame: between baseline and -6th month

    Platelet distribution width (PDW) reflects the variability in platelet size distribution.

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Official study title

Analyzing the Relationship Between Periodontal Health Status and Alzheimer's Disease

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 11, 2023
Registry last updated
Apr 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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