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Periodonitis and Alzheimer's Disease

Periodonitis and Alzheimer's Disease

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05189132
Enrollment
134
Registered
2022-01-12
Start date
2022-09-01
Completion date
2023-01-31
Last updated
2022-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease, Periodontitis

Keywords

Alzheimer Disease, Periodontitis

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).

Interventions

DIAGNOSTIC_TESTPeriodontal 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 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.

DIAGNOSTIC_TESTInflammatory 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.

Sponsors

University of Lisbon
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
FurcationBaslineThe presence of furcation lesions will be evaluated using the Nabers probe. Will be used in the 1975 classification of Hamp * Grade 1 - Loss of horizontal insertion tissue less than 3mm * Grade 2- Loss of horizontal insertion tissue greater than 3mm, but the probe does not it passes from one side to the other. * Grade 3- Loss of horizontal insertion tissue greater than 3mm and the probe passes from side to side
Bleeding on probingBaslineBleeding 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).
Gingival RecessionsBaslineGingival 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
MobilityBaslineMobility 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); * Mobility I: \< 1mm in the horizontal direction; * Mobility II: \> 1mm in the horizontal direction; * Mobility III: horizontal and vertical mobility.
Probing depthBaslineThe 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
Clinical attachment levelBaslineThe clinical insertion level corresponds to the distance from an enamel-cementary junction (JAC) to the bottom of the pocket. * In cases where there is gingival recession, the insertion level is complete through the sum of the probing depth value and the gingival recession value (distance from the gingival margin to the JAC). * In cases where the gingival margin coincides with the JAC, the insertion level value is the same as the probing depth. * If there is a pseudo-pocket, characterized by an increase in gingival volume in the coronal direction, the insertion level value will be the result of subtracting the probing depth value and the distance from the gingival margin to the JAC.
Plaque indexBaslineFor 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

Secondary

MeasureTime frameDescription
Microbiological analysisBaslineMicrobiological 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 MediatorsBaslineThe 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

Other

MeasureTime frameDescription
Cognitive AssessmentBaslineCognitive 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.

Contacts

Primary ContactVanessa Rocha Rodrigues, Dr
vanessa_15_rodrigues@hotmail.com919950890

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026