Investigation of Alzheimer's Disease and Periodontal Status

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05807100
• Other study ID #: KKARADURAN001
• Status: Completed
• Start date: March 2, 2022
• Est. completion date: January 6, 2023

Study information

• Verified date: March 2023
• Source: Bezmialem Vakif University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: January 6, 2023
• Est. primary completion date: January 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 89 Years

Eligibility

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:

-

Related Conditions & MeSH terms

• Alzheimer Disease
• Periodontal Diseases

Intervention

Diagnostic Test:
• Baseline Standardized Mini Mental Test
Cognitive status assessment was done with Standardized Mini Mental Test.
• 6th month Standardized Mini Mental Test
Cognitive status assessment was done with Standardized Mini Mental Test.

Locations

Country	Name	City	State
Turkey	Bezmialem Vakif University	Istanbul	Fatih/Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Gender	The gender distribution of Alzheimer's patients was divided into male and female.	Baseline
Secondary	Age	Ages of Alzheimer's patients were determined.	Baseline
Secondary	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
Secondary	Presence of periodontal disease	Alzheimer patients were evaluated according to the presence and absence of active periodontal disease.	6th month
Secondary	Plaque percentage (%P)	It is an index that shows the amount of microbial dental plaque on the teeth.	6th month
Secondary	Bleeding on probing percentage (%BOP)	Bleeding that is induced by gentle manipulation of the tissue at the depth of the gingival sulcus.	6th month
Secondary	Periodontal probing depth (PPD) (mm)	The distance from the gingival margin to pocket base.	6th month
Secondary	Clinical attachment level (CAL) (mm)	The clinical attachment level is the distance between the enamel-cementum junction and the gingival sulcus.	6th month
Secondary	Number of teeth	The number of teeth present in Alzheimer's patients was determined.	6th month
Secondary	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
Secondary	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
Secondary	Neutrophil ratio (NEUT%)	It refers to the percentage of circulating neutrophils to total white blood cells.	between baseline and -6th month
Secondary	Lymphocyte ratio (LYMPH%)	It refers to the percentage of circulating lymphocytes to total white blood cells.	between baseline and -6th month
Secondary	Neutrophil count (10*3/uL)	It is demonstrates the number of neutrophils in the peripheral blood.	between baseline and -6th month
Secondary	Lymphocyte count (10*3/uL)	It is demonstrates the number of lymphocytes in the peripheral blood.	between baseline and -6th month
Secondary	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
Secondary	Mean platelet volume (fL) (MPV)	Mean platelet volume (MPW) is a measure of the average size of the platelets.	between baseline and -6th month
Secondary	Platelet distribution width (fL) (PDW)	Platelet distribution width (PDW) reflects the variability in platelet size distribution.	between baseline and -6th month