Periodonitis and Alzheimer's Disease

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages Any age
• All sexes
• Healthy volunteers accepted
• Child, Adult, Older adult

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).

Trial locations and contacts

No sites are listed yet.

About this study

Conditions

Alzheimer Disease, Periodontitis

Being tested

Periodontal Diagnosis, Microbiological analysis, Inflammatory mediators

Keywords

Alzheimer Disease, Periodontitis

Medical subject headings

Alzheimer Disease, Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Periodontal DiagnosisDiagnostic test

  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 analysisDiagnostic test

  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 mediatorsDiagnostic test

  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 being measured

The primary outcome is the main question the study is designed to answer.

1. Probing depth

   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

   Measured: Basline

2. Clinical attachment level

   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.

   Measured: Basline

3. Plaque index

   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

   Measured: Basline

4. Bleeding on probing

   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).

   Measured: Basline

5. Gingival Recessions

   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

   Measured: Basline

6. Mobility

   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.

   Measured: Basline

7. Furcation

   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

   Measured: Basline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted12 Jan 2022
2. Study start1 Sep 2022 (estimated)
3. Primary completionNov 2022 (estimated)
4. Study completionJan 2023 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.