- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05189132
Periodonitis and Alzheimer's Disease
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.
Study Overview
Status
Conditions
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).
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Vanessa Rocha Rodrigues, Dr
- Phone Number: 919950890
- Email: vanessa_15_rodrigues@hotmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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).
Description
Inclusion Criteria:
Will be included in the study all individuals who attend the Portuguese Alzheimer's Association, diagnosed with Alzheimer's Disease, who:
- have voluntarily given their consent to participate;
- due to cognitive or functional disability, they were unable to give free and informed consent, but they had this consent given by their representative
- individuals who have participated in the cognitive assessment (only for the test group)
Exclusion Criteria:
- a) refused oral observation.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Test Group
Adult patients diagnosed with Alzheimer's disease
|
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 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. 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).
|
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 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. 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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Probing depth
Time Frame: Basline
|
The probing depth corresponds to the distance from the gingival margin to the bottom of the sulcus or periodontal pocket.
Probing depth measurement will be performed at six locations per tooth, three locations per buccal and three locations per lingual/palatal
|
Basline
|
Clinical attachment level
Time Frame: Basline
|
The clinical insertion level corresponds to the distance from an enamel-cementary junction (JAC) to the bottom of the pocket.
|
Basline
|
Plaque index
Time Frame: Basline
|
For the evaluation of the plaque index (PI), the PI developed by the authors Ainamo and Bay, in 1975, will be used.
It is a dichotomous index, which assesses the presence or absence of bacterial plaque in the cervical area of the tooth in four locations, three locations by vestibular and one location by palatine
|
Basline
|
Bleeding on probing
Time Frame: Basline
|
Bleeding on probing is assessed by looking at bleeding points after periodontal probing.
It will be evaluated in six locations per tooth, three locations per buccal and three locations per lingual/palatal.
A red circle is placed around the sounding depth value (Lang 1986 and 1990).
|
Basline
|
Gingival Recessions
Time Frame: Basline
|
Gingival recession will be evaluated in millimeters and is obtained by the distance from the gingival margin to the JAC.
It will be evaluated in six locations per tooth, three locations per buccal and three locations per lingual/palatal
|
Basline
|
Mobility
Time Frame: Basline
|
Mobility will be assessed with the handle of two instruments (probe and mirror), pushing the tooth in the buccolingual and occlusal-apical directions. The classification proposed by Miller in 1950 will be used, which is divided into: Mobility 0: physiological (0mm to 0.2mm);
|
Basline
|
Furcation
Time Frame: Basline
|
The presence of furcation lesions will be evaluated using the Nabers probe. Will be used in the 1975 classification of Hamp
|
Basline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Microbiological analysis
Time Frame: Basline
|
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. |
Basline
|
Inflammatory Mediators
Time Frame: Basline
|
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 |
Basline
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cognitive Assessment
Time Frame: Basline
|
Cognitive assessment will be performed by neurologists from the Portuguese Alzheimer's Association. Periodontal diagnosis will be performed, through clinical evaluation, to patients with and without Alzheimer's Disease. The Classification of Periodontal and Peri-implant Diseases and Conditions proposed by the American Association of Periodontology (AAP) and the European Federation of Periodontology (EFP) will be used to determine the prevalence of periodontal disease. To assess whether adult patients with different stages of Alzheimer's disease have different stages of severity of Periodontitis (I, II, III and IV), in addition to a periodontal evaluation, it is also evaluated through cognitive tests, at which stage of the disease Alzheimer's patient is found. |
Basline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Vanessa Rocha Rodrigues, Dr, University of Lisbon
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- University Lisbon
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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