Investigation of Alzheimer's Disease and Periodontal Status

Sponsor
Bezmialem Vakif University (Other)
Overall Status
Completed
CT.gov ID
NCT05807100
Collaborator
(none)
90
1
10.2
8.8

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Baseline Standardized Mini Mental Test
  • Diagnostic Test: 6th month Standardized Mini Mental Test

Detailed Description

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).

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
90 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Analyzing the Relationship Between Periodontal Health Status and Alzheimer's Disease
Actual Study Start Date :
Mar 2, 2022
Actual Primary Completion Date :
Jan 6, 2023
Actual Study Completion Date :
Jan 6, 2023

Arms and Interventions

Arm Intervention/Treatment
Stage I

Stage I Alzheimer's Group (n=42): Individuals diagnosed with probable Alzheimer's disease with mild (early stage) dementia according to the Clinical Dementia Rating Scale.

Diagnostic Test: Baseline Standardized Mini Mental Test
Cognitive status assessment was done with Standardized Mini Mental Test.

Diagnostic Test: 6th month Standardized Mini Mental 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.
  • Stage II

    Stage II Alzheimer's Group (n=29): Individuals diagnosed with probable Alzheimer's disease with moderate (moderate stage) dementia according to the Clinical Dementia Rating Scale.

    Diagnostic Test: Baseline Standardized Mini Mental Test
    Cognitive status assessment was done with Standardized Mini Mental Test.

    Diagnostic Test: 6th month Standardized Mini Mental 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.
  • Stage III

    Stage III Alzheimer's Group (n=19): Individuals diagnosed with probable Alzheimer's disease with severe (advanced stage) dementia according to the Clinical Dementia Rating Scale.

    Diagnostic Test: Baseline Standardized Mini Mental Test
    Cognitive status assessment was done with Standardized Mini Mental Test.

    Diagnostic Test: 6th month Standardized Mini Mental 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.
  • Outcome Measures

    Primary Outcome Measures

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

    1. Alzheimer's disease stage [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 [Baseline]

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

    3. Age [Baseline]

      Ages of Alzheimer's patients were determined.

    4. Number of Alzheimer's patient with systemic disease [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 [6th month]

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

    6. Plaque percentage (%P) [6th month]

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

    7. Bleeding on probing percentage (%BOP) [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) [6th month]

      The distance from the gingival margin to pocket base.

    9. Clinical attachment level (CAL) (mm) [6th month]

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

    10. Number of teeth [6th month]

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

    11. Occlusal relationship type [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) [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%) [between baseline and -6th month]

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

    14. Lymphocyte ratio (LYMPH%) [between baseline and -6th month]

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

    15. Neutrophil count (10*3/uL) [between baseline and -6th month]

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

    16. Lymphocyte count (10*3/uL) [between baseline and -6th month]

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

    17. Neutrophil-to-lymphocyte ratio (NLR) [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) [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) [between baseline and -6th month]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 89 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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:

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bezmialem Vakif University Istanbul Fatih/Istanbul Turkey 34093

    Sponsors and Collaborators

    • Bezmialem Vakif University

    Investigators

    • Study Director: Ahmet AYDOĞDU, Bezmialem Vakif University
    • Study Chair: Özlem GELİŞİN, Bezmialem Vakif University
    • Study Chair: Şadiye GÜNPINAR, Bezmialem Vakif University
    • Principal Investigator: Kübra KARADURAN, Bezmialem Vakif University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bezmialem Vakif University
    ClinicalTrials.gov Identifier:
    NCT05807100
    Other Study ID Numbers:
    • KKARADURAN001
    First Posted:
    Apr 11, 2023
    Last Update Posted:
    Apr 11, 2023
    Last Verified:
    Mar 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Bezmialem Vakif University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 11, 2023