Clinical trial NCT05807100: Investigation of Alzheimer's Disease and Periodontal Status
Official title: Analyzing the Relationship Between Periodontal Health Status and Alzheimer's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer Disease
Periodontal Diseases
Keywords: Alzheimer's Disease
Cognitive Decline
Periodontal Disease
Periodontitis
Occlusion
Chewing
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2023-04-11
Enrollment: 90
Sex: ALL
Minimum age (years): 50
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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

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).

Eligibility criteria: 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:

-

Primary outcomes:
measure: Change in Standardized Mini Mental Test (SMMT) score at 6 months
timeFrame: Baseline and 6th month
Secondary outcomes:
measure: Alzheimer's disease stage
timeFrame: Baseline
measure: Gender
timeFrame: Baseline
measure: Age
timeFrame: Baseline
measure: Number of Alzheimer's patient with systemic disease
timeFrame: Baseline
measure: Presence of periodontal disease
timeFrame: 6th month
measure: Plaque percentage (%P)
timeFrame: 6th month
measure: Bleeding on probing percentage (%BOP)
timeFrame: 6th month
measure: Periodontal probing depth (PPD) (mm)
timeFrame: 6th month
measure: Clinical attachment level (CAL) (mm)
timeFrame: 6th month
measure: Number of teeth
timeFrame: 6th month
measure: Occlusal relationship type
timeFrame: 6th month
measure: C-Reactive Protein (CRP) (mg/l)
timeFrame: between baseline and -6th month
measure: Neutrophil ratio (NEUT%)
timeFrame: between baseline and -6th month
measure: Lymphocyte ratio (LYMPH%)
timeFrame: between baseline and -6th month
measure: Neutrophil count (10*3/uL)
timeFrame: between baseline and -6th month
measure: Lymphocyte count (10*3/uL)
timeFrame: between baseline and -6th month
measure: Neutrophil-to-lymphocyte ratio (NLR)
timeFrame: between baseline and -6th month
measure: Mean platelet volume (fL) (MPV)
timeFrame: between baseline and -6th month
measure: Platelet distribution width (fL) (PDW)
timeFrame: between baseline and -6th month
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University
state: Fatih/Istanbul
Study officials:
affiliation: Bezmialem Vakif University
name: Ahmet AYDOĞDU
role: STUDY_DIRECTOR
affiliation: Bezmialem Vakif University
name: Özlem GELİŞİN
role: STUDY_CHAIR
affiliation: Bezmialem Vakif University
name: Şadiye GÜNPINAR
role: STUDY_CHAIR
affiliation: Bezmialem Vakif University
name: Kübra KARADURAN
role: PRINCIPAL_INVESTIGATOR
References: