Periodonitis and Alzheimer's Disease

Sponsor
University of Lisbon (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05189132
Collaborator
(none)
134
4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Periodontal Diagnosis
  • Diagnostic Test: Microbiological analysis
  • Diagnostic Test: Inflammatory mediators

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 Design

Study Type:
Observational
Anticipated Enrollment :
134 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Periodonitis and Alzheimer's Disease
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Nov 1, 2022
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Test Group

Adult patients diagnosed with Alzheimer's disease

Diagnostic Test: 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

Diagnostic Test: 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.

Diagnostic Test: 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).

Diagnostic Test: 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

Diagnostic Test: 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.

Diagnostic Test: 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.

Outcome Measures

Primary Outcome Measures

  1. Probing depth [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

  2. Clinical attachment level [Basline]

    The 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.

  3. Plaque index [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

  4. Bleeding on probing [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).

  5. Gingival Recessions [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

  6. Mobility [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); Mobility I: < 1mm in the horizontal direction; Mobility II: > 1mm in the horizontal direction; Mobility III: horizontal and vertical mobility.

  7. Furcation [Basline]

    The 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

Secondary Outcome Measures

  1. Microbiological analysis [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.

  2. Inflammatory Mediators [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

Other Outcome Measures

  1. Cognitive Assessment [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts 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:
    1. refused oral observation.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Lisbon

Investigators

  • Principal Investigator: Vanessa Rocha Rodrigues, Dr, University of Lisbon

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Vanessa Rocha Rodrigues, Principal Investigator, University of Lisbon
ClinicalTrials.gov Identifier:
NCT05189132
Other Study ID Numbers:
  • University Lisbon
First Posted:
Jan 12, 2022
Last Update Posted:
Jun 24, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Vanessa Rocha Rodrigues, Principal Investigator, University of Lisbon
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 24, 2022