Investigation of Alzheimer's Disease and Periodontal Status

NCT ID: NCT05807100

Last Updated: 2023-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-02

Study Completion Date

2023-01-06

Brief Summary

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

Detailed Description

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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).

Conditions

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Alzheimer Disease Periodontal Diseases

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Baseline Standardized Mini Mental Test

Intervention Type DIAGNOSTIC_TEST

Cognitive status assessment was done with Standardized Mini Mental Test.

6th month Standardized Mini Mental Test

Intervention Type DIAGNOSTIC_TEST

Cognitive status assessment was done with Standardized Mini Mental Test.

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.

Baseline Standardized Mini Mental Test

Intervention Type DIAGNOSTIC_TEST

Cognitive status assessment was done with Standardized Mini Mental Test.

6th month Standardized Mini Mental Test

Intervention Type DIAGNOSTIC_TEST

Cognitive status assessment was done with Standardized Mini Mental Test.

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.

Baseline Standardized Mini Mental Test

Intervention Type DIAGNOSTIC_TEST

Cognitive status assessment was done with Standardized Mini Mental Test.

6th month Standardized Mini Mental Test

Intervention Type DIAGNOSTIC_TEST

Cognitive status assessment was done with Standardized Mini Mental Test.

Interventions

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Baseline Standardized Mini Mental Test

Cognitive status assessment was done with Standardized Mini Mental Test.

Intervention Type DIAGNOSTIC_TEST

6th month Standardized Mini Mental Test

Cognitive status assessment was done with Standardized Mini Mental Test.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Periodontal Examination: Toothed/edentulous condition, occlusal relationship type and periodontal status were evaluated by periodontal examination.

Eligibility Criteria

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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

\-
Minimum Eligible Age

50 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bezmialem Vakif University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ahmet AYDOĞDU

Role: STUDY_DIRECTOR

Bezmialem Vakif University

Özlem GELİŞİN

Role: STUDY_CHAIR

Bezmialem Vakif University

Şadiye GÜNPINAR

Role: STUDY_CHAIR

Bezmialem Vakif University

Kübra KARADURAN

Role: PRINCIPAL_INVESTIGATOR

Bezmialem Vakif University

Locations

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Bezmialem Vakif University

Istanbul, Fatih/Istanbul, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Karaduran K, Aydogdu A, Gelisin O, Gunpinar S. Investigating the potential clinical impact of periodontitis on the progression of Alzheimer's disease: a prospective cohort study. Clin Oral Investig. 2023 Dec 30;28(1):67. doi: 10.1007/s00784-023-05445-w.

Reference Type DERIVED
PMID: 38159159 (View on PubMed)

Other Identifiers

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KKARADURAN001

Identifier Type: -

Identifier Source: org_study_id

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