- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05807100
Investigation of Alzheimer's Disease and Periodontal Status
Analyzing the Relationship Between Periodontal Health Status and Alzheimer's Disease
Study Overview
Status
Conditions
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Fatih/Istanbul
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Istanbul, Fatih/Istanbul, Turkey, 34093
- Bezmialem Vakif University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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.
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Cognitive status assessment was done with Standardized Mini Mental Test.
Cognitive status assessment was done with Standardized Mini Mental Test.
Other Names:
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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.
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Cognitive status assessment was done with Standardized Mini Mental Test.
Cognitive status assessment was done with Standardized Mini Mental Test.
Other Names:
|
|
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.
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Cognitive status assessment was done with Standardized Mini Mental Test.
Cognitive status assessment was done with Standardized Mini Mental Test.
Other Names:
|
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
Time Frame: Baseline and 6th month
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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.
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Baseline and 6th month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Alzheimer's disease stage
Time Frame: Baseline
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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
|
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Gender
Time Frame: Baseline
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The gender distribution of Alzheimer's patients was divided into male and female.
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Baseline
|
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Age
Time Frame: Baseline
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Ages of Alzheimer's patients were determined.
|
Baseline
|
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Number of Alzheimer's patient with systemic disease
Time Frame: Baseline
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The current systemic conditions of Alzheimer's patients were evaluated and those with diabetes mellitus and cardiovascular disease were determined.
|
Baseline
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Presence of periodontal disease
Time Frame: 6th month
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Alzheimer patients were evaluated according to the presence and absence of active periodontal disease.
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6th month
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Plaque percentage (%P)
Time Frame: 6th month
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It is an index that shows the amount of microbial dental plaque on the teeth.
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6th month
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Bleeding on probing percentage (%BOP)
Time Frame: 6th month
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Bleeding that is induced by gentle manipulation of the tissue at the depth of the gingival sulcus.
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6th month
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Periodontal probing depth (PPD) (mm)
Time Frame: 6th month
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The distance from the gingival margin to pocket base.
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6th month
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Clinical attachment level (CAL) (mm)
Time Frame: 6th month
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The clinical attachment level is the distance between the enamel-cementum junction and the gingival sulcus.
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6th month
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Number of teeth
Time Frame: 6th month
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The number of teeth present in Alzheimer's patients was determined.
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6th month
|
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Occlusal relationship type
Time Frame: 6th month
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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.
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6th month
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C-Reactive Protein (CRP) (mg/l)
Time Frame: between baseline and -6th month
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C-Reactive Protein (CRP) is a protein found in blood plasma whose circulating concentration is associated with inflammation.
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between baseline and -6th month
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Neutrophil ratio (NEUT%)
Time Frame: between baseline and -6th month
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It refers to the percentage of circulating neutrophils to total white blood cells.
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between baseline and -6th month
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Lymphocyte ratio (LYMPH%)
Time Frame: between baseline and -6th month
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It refers to the percentage of circulating lymphocytes to total white blood cells.
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between baseline and -6th month
|
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Neutrophil count (10*3/uL)
Time Frame: between baseline and -6th month
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It is demonstrates the number of neutrophils in the peripheral blood.
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between baseline and -6th month
|
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Lymphocyte count (10*3/uL)
Time Frame: between baseline and -6th month
|
It is demonstrates the number of lymphocytes in the peripheral blood.
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between baseline and -6th month
|
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Neutrophil-to-lymphocyte ratio (NLR)
Time Frame: between baseline and -6th month
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Neutrophil-to-lymphocyte ratio (NLR) is calculated by dividing the absolute number of neutrophils by absolute number of lymphocytes.
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between baseline and -6th month
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Mean platelet volume (fL) (MPV)
Time Frame: between baseline and -6th month
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Mean platelet volume (MPW) is a measure of the average size of the platelets.
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between baseline and -6th month
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Platelet distribution width (fL) (PDW)
Time Frame: between baseline and -6th month
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Platelet distribution width (PDW) reflects the variability in platelet size distribution.
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between baseline and -6th month
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Collaborators and Investigators
Sponsor
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)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
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)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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