Investigation of Alzheimer's Disease and Periodontal Status

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

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

Study Overview

• Status: Completed
• Conditions: Periodontal Diseases; Alzheimer Disease
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

Study Locations

• Turkey
  • Fatih/Istanbul
    • Istanbul, Fatih/Istanbul, Turkey, 34093
      • Bezmialem Vakif University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Individuals diagnosed with mild/moderate/severe probable Alzheimer's disease according to the Clinical Dementia Rating Scale who meet the inclusion criteria

Description

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:

-

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Standardized Mini Mental Test (SMMT) score at 6 months	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.	Baseline and 6th month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alzheimer's disease stage	The stage of Alzheimer's disease was determined according to the clinical dementia rating scale. Stage I: Mild, Stage II: Moderate, Stage III: Severe.	Baseline
Gender	The gender distribution of Alzheimer's patients was divided into male and female.	Baseline
Age	Ages of Alzheimer's patients were determined.	Baseline
Number of Alzheimer's patient with systemic disease	The current systemic conditions of Alzheimer's patients were evaluated and those with diabetes mellitus and cardiovascular disease were determined.	Baseline
Presence of periodontal disease	Alzheimer patients were evaluated according to the presence and absence of active periodontal disease.	6th month
Plaque percentage (%P)	It is an index that shows the amount of microbial dental plaque on the teeth.	6th month
Bleeding on probing percentage (%BOP)	Bleeding that is induced by gentle manipulation of the tissue at the depth of the gingival sulcus.	6th month
Periodontal probing depth (PPD) (mm)	The distance from the gingival margin to pocket base.	6th month
Clinical attachment level (CAL) (mm)	The clinical attachment level is the distance between the enamel-cementum junction and the gingival sulcus.	6th month
Number of teeth	The number of teeth present in Alzheimer's patients was determined.	6th month
Occlusal relationship type	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	6th month
C-Reactive Protein (CRP) (mg/l)	C-Reactive Protein (CRP) is a protein found in blood plasma whose circulating concentration is associated with inflammation.	between baseline and -6th month
Neutrophil ratio (NEUT%)	It refers to the percentage of circulating neutrophils to total white blood cells.	between baseline and -6th month
Lymphocyte ratio (LYMPH%)	It refers to the percentage of circulating lymphocytes to total white blood cells.	between baseline and -6th month
Neutrophil count (10*3/uL)	It is demonstrates the number of neutrophils in the peripheral blood.	between baseline and -6th month
Lymphocyte count (10*3/uL)	It is demonstrates the number of lymphocytes in the peripheral blood.	between baseline and -6th month
Neutrophil-to-lymphocyte ratio (NLR)	Neutrophil-to-lymphocyte ratio (NLR) is calculated by dividing the absolute number of neutrophils by absolute number of lymphocytes.	between baseline and -6th month
Mean platelet volume (fL) (MPV)	Mean platelet volume (MPW) is a measure of the average size of the platelets.	between baseline and -6th month
Platelet distribution width (fL) (PDW)	Platelet distribution width (PDW) reflects the variability in platelet size distribution.	between baseline and -6th month

Collaborators and Investigators

• Sponsor: Bezmialem Vakif University
• Investigators: Study Director: Ahmet AYDOĞDU, Bezmialem Vakif University; Study Chair: Özlem GELİŞİN, Bezmialem Vakif University; Study Chair: SADIYE GUNPINAR, Bezmialem Vakif University; Principal Investigator: Kübra KARADURAN, Bezmialem Vakif University

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2022
• Primary Completion (Actual): January 6, 2023
• Study Completion (Actual): January 6, 2023

Study Registration Dates

• First Submitted: March 13, 2023
• First Submitted That Met QC Criteria: March 28, 2023
• First Posted (Actual): April 11, 2023

Study Record Updates

• Last Update Posted (Actual): April 11, 2023
• Last Update Submitted That Met QC Criteria: March 28, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Alzheimer's Disease; Periodontitis; Occlusion; Cognitive Decline; Periodontal Disease; Chewing
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Stomatognathic Diseases; Mouth Diseases; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease; Periodontal Diseases; Anti-Infective Agents; Dermatologic Agents; Antifungal Agents; Keratolytic Agents; Salicylic Acid
• Other Study ID Numbers: KKARADURAN001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Data will be shared if requested.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No