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Clinical Trials/NCT05807100
NCT05807100
Completed
Not Applicable

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

Bezmialem Vakif University1 site in 1 country90 target enrollmentMarch 2, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Alzheimer Disease
Sponsor
Bezmialem Vakif University
Enrollment
90
Locations
1
Primary Endpoint
Change in Standardized Mini Mental Test (SMMT) score at 6 months
Status
Completed
Last Updated
3 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
March 2, 2022
End Date
January 6, 2023
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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

  • Not provided

Outcomes

Primary Outcomes

Change in Standardized Mini Mental Test (SMMT) score at 6 months

Time Frame: 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 Outcomes

  • Alzheimer's disease stage(Baseline)
  • Presence of periodontal disease(6th month)
  • Gender(Baseline)
  • Periodontal probing depth (PPD) (mm)(6th month)
  • Age(Baseline)
  • Bleeding on probing percentage (%BOP)(6th month)
  • Number of Alzheimer's patient with systemic disease(Baseline)
  • Number of teeth(6th month)
  • Platelet distribution width (fL) (PDW)(between baseline and -6th month)
  • Plaque percentage (%P)(6th month)
  • Neutrophil count (10*3/uL)(between baseline and -6th month)
  • Clinical attachment level (CAL) (mm)(6th month)
  • C-Reactive Protein (CRP) (mg/l)(between baseline and -6th month)
  • Neutrophil ratio (NEUT%)(between baseline and -6th month)
  • Occlusal relationship type(6th month)
  • Lymphocyte ratio (LYMPH%)(between baseline and -6th month)
  • Lymphocyte count (10*3/uL)(between baseline and -6th month)
  • Neutrophil-to-lymphocyte ratio (NLR)(between baseline and -6th month)
  • Mean platelet volume (fL) (MPV)(between baseline and -6th month)

Study Sites (1)

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