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临床试验/NCT05189132
NCT05189132Unknown不适用

Periodonitis and Alzheimer's Disease

University of Lisbon0 个研究点目标入组 134 人开始时间: 2022年9月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
134
主要终点
Probing depth

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • a) refused oral observation.

结局指标

主要结局

Probing depth

时间窗: 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

Clinical attachment level

时间窗: 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.

Plaque index

时间窗: 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

Bleeding on probing

时间窗: 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).

Gingival Recessions

时间窗: 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

Mobility

时间窗: 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.

Furcation

时间窗: 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

次要结局

  • Microbiological analysis(Basline)
  • Inflammatory Mediators(Basline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Vanessa Rocha Rodrigues

Principal Investigator

University of Lisbon

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