Идёт набор NCT07167771

LONGITUDINAL FOLLOW-UP STUDY TO DETERMINE THE PREDICTIVE ABILITY OF A PANEL OF BIOMARKERS IN SALIVA IN HEALTHY AND PERIODONTALLY AFFECTED PATIENTS

— Наблюдательное Periodontal Diseases

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: No intervention.
Кому может быть актуально: Состояния в реестре: Periodontal Diseases. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Испания
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Objective: The main aim of this longitudinal clinical study is to evaluate the predictive ability of a panel of salivary biomarkers in determining periodontal health status in 2 years follow up in a group of healthy and periodontally affected individuals. Material and methods: In this longitudinal, observational follow-up study, patients previously enrolled in a cross-sectional study at the Periodontal Postgraduate Clinic, University Complutense of Madrid, will be re-evaluated over a 2-year period. Participants (≥18 years) will be categorized into diagnostic groups based on the 2018 classification of periodontal diseases, including periodontally healthy, gingivitis, treated periodontitis (stable/unstable), and various stages of periodontitis. The study will include follow-up visits at 1 and 2 years. At each visit, participants will undergo a comprehensive medical examination to assess age, gender, weight, height, waist circumference, blood pressure, temperature, smoking and alcohol history, systemic health, and HbA1c levels. A periodontal examination will be performed at six sites per tooth, and clinical parameters including plaque, bleeding on probing, probing depth, recession, and tooth loss will be recorded. Saliva and subgingival plaque samples will be collected for biomarker and microbiological analysis. Salivary biomarkers will be measured using multiplex immunoassays, and bacterial quantification will be performed by multiplex qPCR. Data analyses: Descriptive statistics will be used to report the clinical variables and patients will be grouped according to the pre-established diagnostic categories (periodontally healthy, gingivitis, treated periodontitis patient. In order to determine the possible statistical relationship with the medical, biochemical and microbiological variables assessed, a crude bivariate analysis will first be performed by applying a mean comparison test for quantitative variables (ANOVA) and a proportion comparison test for categorical variables (Chi-square). Subsequently, those variables identified as relevant in the crude analyses will be included as confounding and/or interaction factors in a binary logistic regression model, considering the presence of periodontitis as a response variable, in order to obtain crude and adjusted OR values, together with their corresponding 95% CIs. Based on the results obtained in the biomarker analysis, a relevant statistical analysis will be performed, taking into account all the variables collected in the study. For periodontitis cases, treatment response over time will be analyzed, with subgroup comparisons between responders and non-responders.

Вмешательства

Другое No intervention
There is not intervention in these patients, appart from their normal dental check-up visits.

Первичные конечные точки

Salivary biomarkers [Срок оценки: Baseline, 1 and 2 years]

Вторичные конечные точки (12)

Age [Срок оценки: Baseline, 1 and 2 years]
Gender [Срок оценки: Baseline, 1 and 2 years]
Weight [Срок оценки: Baseline, 1 and 2 years]
Height [Срок оценки: Baseline, 1 and 2 years]
Waist circumference [Срок оценки: Baseline, 1 and 2 years]
HbA1c [Срок оценки: Baseline, 1 and 2 years]
Blood pressure [Срок оценки: Baseline, 1 and 2 years]
Temperature [Срок оценки: Baseline, 1 and 2 years]
Drug, alcohol, and smoking history [Срок оценки: Baseline, 1 and 2 years]
Nicotine dependency [Срок оценки: Baseline, 1 and 2 years]
Health anamnesis [Срок оценки: Baseline, 1 and 2 years]
Presence and quantification of specific periodontal pathogens [Срок оценки: Baseline, 1 and 2 years]

Критерии участия

Критерии включения

Participants from the cohort involved in the previous cross-sectional study (code 23/481-E).
Adults (≥ 18-year-old)
Being able to sign an informed consent form
Willing to participate in this observational investigation
Diagnosed as periodontally healthy, gingivitis, treated periodontitis patient (stable / unstable), periodontitis stages I \& II, or periodontitis stages III and IV (Papapanou et al. 2023) in the previous cross-sectional study (code 23/481-E)