Investigation of Alzheimer's Disease and Periodontal Status

NCT05807100 | Completed

• 1 other identifier: KKARADURAN001
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Alzheimer Disease; Periodontal Diseases

Keywords

Alzheimer's Disease; Cognitive Decline; Periodontal Disease; Periodontitis; Occlusion; Chewing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (19)

• Alzheimer's disease stage

  Baseline

• Gender

  Baseline

• Age

  Baseline

• Number of Alzheimer's patient with systemic disease

  Baseline

• Presence of periodontal disease

  6th month

Study Arms (3)

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.

Diagnostic Test: Baseline Standardized Mini Mental Test; Diagnostic Test: 6th month 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.

Diagnostic Test: Baseline Standardized Mini Mental Test; Diagnostic Test: 6th month 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.

Diagnostic Test: Baseline Standardized Mini Mental Test; Diagnostic Test: 6th month Standardized Mini Mental Test

Interventions

Baseline Standardized Mini Mental Test DIAGNOSTIC_TEST

Cognitive status assessment was done with Standardized Mini Mental Test.

Stage I; Stage II; Stage III

6th month Standardized Mini Mental Test DIAGNOSTIC_TEST

Cognitive status assessment was done with Standardized Mini Mental Test.

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

Stage I; Stage II; Stage III

Eligibility Criteria

• Age: 50 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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
• 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.

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakif University

Istanbul, Fatih/Istanbul, 34093, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 38159159 DERIVED

MeSH Terms

Conditions

Alzheimer Disease; Periodontal Diseases; Cognitive Dysfunction; Periodontitis; Bites and Stings

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Mouth Diseases; Stomatognathic Diseases; Cognition Disorders; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Officials

• Ahmet AYDOĞDU

  Bezmialem Vakif University

  STUDY DIRECTOR

• Özlem GELİŞİN

  Bezmialem Vakif University

  STUDY CHAIR

• Şadiye GÜNPINAR

  Bezmialem Vakif University

  STUDY CHAIR

• Kübra KARADURAN

  Bezmialem Vakif University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2023
• First Posted: April 11, 2023
• Study Start: March 2, 2022
• Primary Completion: January 6, 2023
• Study Completion: January 6, 2023
• Last Updated: April 11, 2023

Record last verified: 2023-03

Locations

TU (1)