Clinical trial NCT05189132: Periodonitis and Alzheimer's Disease
Official title: Periodonitis and Alzheimer's Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Alzheimer Disease
Periodontitis
Keywords: Alzheimer Disease
Periodontitis
Lead sponsor: University of Lisbon
Sponsor class: OTHER
First posted: 2022-01-12
Enrollment: 134
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: It will be evaluated whether adult patients diagnosed with Alzheimer's Disease have a higher prevalence of Periodontal Disease when compared to adult patients without Alzheimer's Disease.

As well, it will be evaluated whether adult patients with different stages of Alzheimer's disease have different stages of severity of Periodontitis.

The study sample will be obtained from the Associação Portuguesa de Alzheimer, in the Lisbon region, consisting of adult patients diagnosed with Alzheimer's Disease (test group).

The control group sample will consist of patients who attend consultations at the Faculty of Dental Medicine, University of Lisbon, matched for age, gender and other confounding factors, such as tobacco and systemic diseases (diabetes).

Brief summary: The main objective of this study is to assess whether Periodontal Disease is more prevalent in adult patients diagnosed with Alzheimer's Disease compared to adult patients without Alzheimer's Disease.

The secondary objective is to describe and characterize the microbiological and biochemical profile of adult patients diagnosed with Alzheimer's Disease and compare with adult patients without Alzheimer's Disease.

Detailed description: To assess the possible association of Periodontal Disease with Alzheimer's Disease, I propose to carry out an observational, paired and cross-sectional study.

It will be evaluated whether adult patients diagnosed with Alzheimer's Disease have a higher prevalence of Periodontal Disease when compared to adult patients without Alzheimer's Disease.

As well, it will be evaluated whether adult patients with different stages of Alzheimer's disease have different stages of severity of Periodontitis.

The study sample will be obtained from the Associação Portuguesa de Alzheimer, in the Lisbon region, consisting of adult patients diagnosed with Alzheimer's Disease (test group).

The control group sample will consist of patients who attend consultations at the Faculty of Dental Medicine, University of Lisbon, matched for age, gender and other confounding factors, such as tobacco and systemic diseases (diabetes).

Eligibility criteria: Inclusion Criteria:

Will be included in the study all individuals who attend the Portuguese Alzheimer's Association, diagnosed with Alzheimer's Disease, who:

1. have voluntarily given their consent to participate;
2. due to cognitive or functional disability, they were unable to give free and informed consent, but they had this consent given by their representative
3. individuals who have participated in the cognitive assessment (only for the test group)

Exclusion Criteria:

* a) refused oral observation.

Primary outcomes:
measure: Probing depth
timeFrame: Basline
measure: Clinical attachment level
timeFrame: Basline
measure: Plaque index
timeFrame: Basline
measure: Bleeding on probing
timeFrame: Basline
measure: Gingival Recessions
timeFrame: Basline
measure: Mobility
timeFrame: Basline
measure: Furcation
timeFrame: Basline
Secondary outcomes:
measure: Microbiological analysis
timeFrame: Basline
measure: Inflammatory Mediators
timeFrame: Basline
Other outcomes:
measure: Cognitive Assessment
timeFrame: Basline
Locations:
Study officials:
affiliation: University of Lisbon
name: Vanessa Rocha Rodrigues, Dr
role: PRINCIPAL_INVESTIGATOR
References: