AzTrials
AzTrials

Alzheimer DiseaseNCT05807100

Investigation of Alzheimer's Disease and Periodontal Status

An observational study of Alzheimer Disease and Periodontal Diseases, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 50 to 89 years
Conditions the study is for
Alzheimer Disease, Periodontal Diseases
What is being tested?
Baseline Standardized Mini Mental Test and 6th month Standardized Mini Mental Test
How many people
90 participants
Where
1 siteTurkey (Türkiye)
Study dates
2 Mar 2022to 6 Jan 2023
How long will I take part?
6 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 89 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Individuals diagnosed with mild/moderate/severe probable Alzheimer's disease according to the Clinical Dementia Rating Scale who meet the inclusion criteria

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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.

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Bezmialem Vakif University

    Istanbul, Fatih/Istanbul, 34093

Other trials in Turkey (Türkiye)

About this study

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

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

Read the 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).

Being tested
Baseline Standardized Mini Mental Test, 6th month Standardized Mini Mental Test
Keywords
Alzheimer's Disease, Cognitive Decline, Periodontal Disease, Periodontitis, Occlusion, Chewing
Medical subject headings
Alzheimer Disease, Periodontal Diseases, Cognitive Dysfunction, Periodontitis, Bites and Stings

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Baseline Standardized Mini Mental TestDiagnostic test

    Cognitive status assessment was done with Standardized Mini Mental Test.

  • 6th month Standardized Mini Mental TestDiagnostic test

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

    Cognitive status assessment was done with Standardized Mini Mental Test.

Study groups in NCT05807100
Study groupRoleWhat they receive
Stage IStage 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.
Receives: Diagnostic Test: Baseline Standardized Mini Mental Test; Diagnostic Test: 6th month Standardized Mini Mental Test
Stage IIStage 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.
Receives: Diagnostic Test: Baseline Standardized Mini Mental Test; Diagnostic Test: 6th month Standardized Mini Mental Test
Stage IIIStage 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.
Receives: Diagnostic Test: Baseline Standardized Mini Mental Test; Diagnostic Test: 6th month Standardized Mini Mental Test

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline and 6th month

Secondary outcomes (19)

  1. Alzheimer's disease stage

    The stage of Alzheimer's disease was determined according to the clinical dementia rating scale.

    Stage I: Mild, Stage II: Moderate, Stage III: Severe.

    Measured: Baseline

  2. Gender

    The gender distribution of Alzheimer's patients was divided into male and female.

    Measured: Baseline

  3. Age

    Ages of Alzheimer's patients were determined.

    Measured: Baseline

  4. Number of Alzheimer's patient with systemic disease

    The current systemic conditions of Alzheimer's patients were evaluated and those with diabetes mellitus and cardiovascular disease were determined.

    Measured: Baseline

  5. Presence of periodontal disease

    Alzheimer patients were evaluated according to the presence and absence of active periodontal disease.

    Measured: 6th month

  6. Plaque percentage (%P)

    It is an index that shows the amount of microbial dental plaque on the teeth.

    Measured: 6th month

  7. Bleeding on probing percentage (%BOP)

    Bleeding that is induced by gentle manipulation of the tissue at the depth of the gingival sulcus.

    Measured: 6th month

  8. Periodontal probing depth (PPD) (mm)

    The distance from the gingival margin to pocket base.

    Measured: 6th month

  9. Clinical attachment level (CAL) (mm)

    The clinical attachment level is the distance between the enamel-cementum junction and the gingival sulcus.

    Measured: 6th month

  10. Number of teeth

    The number of teeth present in Alzheimer's patients was determined.

    Measured: 6th month

  11. Occlusal relationship type

    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.

    • Type 1: A1-A2-A3-B1
    • Type 2: B2-B3
    • Type 3: B4-C1-C2-C3

    Measured: 6th month

  12. C-Reactive Protein (CRP) (mg/l)

    C-Reactive Protein (CRP) is a protein found in blood plasma whose circulating concentration is associated with inflammation.

    Measured: between baseline and -6th month

  13. Neutrophil ratio (NEUT%)

    It refers to the percentage of circulating neutrophils to total white blood cells.

    Measured: between baseline and -6th month

  14. Lymphocyte ratio (LYMPH%)

    It refers to the percentage of circulating lymphocytes to total white blood cells.

    Measured: between baseline and -6th month

  15. Neutrophil count (10*3/uL)

    It is demonstrates the number of neutrophils in the peripheral blood.

    Measured: between baseline and -6th month

  16. Lymphocyte count (10*3/uL)

    It is demonstrates the number of lymphocytes in the peripheral blood.

    Measured: between baseline and -6th month

  17. Neutrophil-to-lymphocyte ratio (NLR)

    Neutrophil-to-lymphocyte ratio (NLR) is calculated by dividing the absolute number of neutrophils by absolute number of lymphocytes.

    Measured: between baseline and -6th month

  18. Mean platelet volume (fL) (MPV)

    Mean platelet volume (MPW) is a measure of the average size of the platelets.

    Measured: between baseline and -6th month

  19. Platelet distribution width (fL) (PDW)

    Platelet distribution width (PDW) reflects the variability in platelet size distribution.

    Measured: between baseline and -6th month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2023
  2. Study start2 Mar 2022
  3. Primary completion6 Jan 2023
  4. Study completion6 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
90 participants (actual)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT05807100
Sponsor's protocol ID
KKARADURAN001
Status last verified
Mar 2023
First submitted
13 Mar 2023
Last updated
11 Apr 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Data will be shared if requested.

Publications

  • 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.

    PubMed 38159159

Questions about this trial

What is this clinical trial studying?

An observational study of Alzheimer Disease and Periodontal Diseases, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Standardized Mini Mental Test (SMMT) score at 6 months (time frame: Baseline and 6th month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05807100, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2023.

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