Study Results
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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UNKNOWN
134 participants
OBSERVATIONAL
2022-09-01
2023-01-31
Brief Summary
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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.
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Detailed Description
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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).
Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Test Group
Adult patients diagnosed with Alzheimer's disease
Periodontal Diagnosis
All participants, in the test group and in the control group, will undergo an initial periodontal evaluation. The clinical evaluation will always be carried out by the same examiner, the author of the study, in order to guarantee calibrated observations. During data collection, intra-observer calibration will be performed, as recommended by the WHO (WHO, 1993), in order to minimize diagnostic variability and verify agreement
Microbiological analysis
Microbiological analysis will be performed using a sample of subgingival bacterial plaque. The sample will be collected at the tooth and at the location with the highest probing depth values in each quadrant.
A sterilized paper tip from the microbiological kit will be introduced to the bottom of the bag, with the aid of tweezers, remaining in the same position for 10 seconds. After collecting the sample, the paper tip will be placed in an individual transfer tube, properly identified. Afterwards, the sample will be sent to the laboratory, where a polymerase chain reaction (PCR) test is performed to identify the following bacteria - A. actinomycetemcomitans, T. forsythia, T. denticola, P. gingivalis, P. intermedia and F. nucleatum.
Inflammatory mediators
The evaluation of inflammatory mediators will be performed with the aid of an absorbent paper strip, which is placed inside the periodontal pocket, for about 30 seconds. The sample will be taken from the tooth that has the highest probing depth values.
The collected sample will be placed and stored in an individual transfer tube properly identified and in accordance with the laboratory's instructions. Afterwards, the sample will be sent to the laboratory, where the ELISA test is performed to quantify the following inflammatory mediators - IL-1β, IL-6 and TNF-α.
Control Group
The control group will consist of patients who attend consultations at the Faculty of Dentistry of the University of Lisbon, matched for age, gender and other confounding factors, such as smoking and systemic diseases (diabetes).
Periodontal Diagnosis
All participants, in the test group and in the control group, will undergo an initial periodontal evaluation. The clinical evaluation will always be carried out by the same examiner, the author of the study, in order to guarantee calibrated observations. During data collection, intra-observer calibration will be performed, as recommended by the WHO (WHO, 1993), in order to minimize diagnostic variability and verify agreement
Microbiological analysis
Microbiological analysis will be performed using a sample of subgingival bacterial plaque. The sample will be collected at the tooth and at the location with the highest probing depth values in each quadrant.
A sterilized paper tip from the microbiological kit will be introduced to the bottom of the bag, with the aid of tweezers, remaining in the same position for 10 seconds. After collecting the sample, the paper tip will be placed in an individual transfer tube, properly identified. Afterwards, the sample will be sent to the laboratory, where a polymerase chain reaction (PCR) test is performed to identify the following bacteria - A. actinomycetemcomitans, T. forsythia, T. denticola, P. gingivalis, P. intermedia and F. nucleatum.
Inflammatory mediators
The evaluation of inflammatory mediators will be performed with the aid of an absorbent paper strip, which is placed inside the periodontal pocket, for about 30 seconds. The sample will be taken from the tooth that has the highest probing depth values.
The collected sample will be placed and stored in an individual transfer tube properly identified and in accordance with the laboratory's instructions. Afterwards, the sample will be sent to the laboratory, where the ELISA test is performed to quantify the following inflammatory mediators - IL-1β, IL-6 and TNF-α.
Interventions
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Periodontal Diagnosis
All participants, in the test group and in the control group, will undergo an initial periodontal evaluation. The clinical evaluation will always be carried out by the same examiner, the author of the study, in order to guarantee calibrated observations. During data collection, intra-observer calibration will be performed, as recommended by the WHO (WHO, 1993), in order to minimize diagnostic variability and verify agreement
Microbiological analysis
Microbiological analysis will be performed using a sample of subgingival bacterial plaque. The sample will be collected at the tooth and at the location with the highest probing depth values in each quadrant.
A sterilized paper tip from the microbiological kit will be introduced to the bottom of the bag, with the aid of tweezers, remaining in the same position for 10 seconds. After collecting the sample, the paper tip will be placed in an individual transfer tube, properly identified. Afterwards, the sample will be sent to the laboratory, where a polymerase chain reaction (PCR) test is performed to identify the following bacteria - A. actinomycetemcomitans, T. forsythia, T. denticola, P. gingivalis, P. intermedia and F. nucleatum.
Inflammatory mediators
The evaluation of inflammatory mediators will be performed with the aid of an absorbent paper strip, which is placed inside the periodontal pocket, for about 30 seconds. The sample will be taken from the tooth that has the highest probing depth values.
The collected sample will be placed and stored in an individual transfer tube properly identified and in accordance with the laboratory's instructions. Afterwards, the sample will be sent to the laboratory, where the ELISA test is performed to quantify the following inflammatory mediators - IL-1β, IL-6 and TNF-α.
Eligibility Criteria
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Inclusion Criteria
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
ALL
Yes
Sponsors
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University of Lisbon
OTHER
Responsible Party
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Vanessa Rocha Rodrigues
Principal Investigator
Principal Investigators
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Vanessa Rocha Rodrigues, Dr
Role: PRINCIPAL_INVESTIGATOR
University of Lisbon
Central Contacts
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Other Identifiers
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University Lisbon
Identifier Type: -
Identifier Source: org_study_id
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