LONGITUDINAL FOLLOW-UP STUDY TO DETERMINE THE PREDICTIVE ABILITY OF A PANEL OF BIOMARKERS IN SALIVA IN HEALTHY AND PERIODONTALLY AFFECTED PATIENTS
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No intervention.
- Who it may be relevant to
- Registry conditions: Periodontal Diseases. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other No intervention
There is not intervention in these patients, appart from their normal dental check-up visits.
Primary outcome measures
- Salivary biomarkers [Time frame: Baseline, 1 and 2 years]
Secondary outcome measures (12)
- Age [Time frame: Baseline, 1 and 2 years]
- Gender [Time frame: Baseline, 1 and 2 years]
- Weight [Time frame: Baseline, 1 and 2 years]
- Height [Time frame: Baseline, 1 and 2 years]
- Waist circumference [Time frame: Baseline, 1 and 2 years]
- HbA1c [Time frame: Baseline, 1 and 2 years]
- Blood pressure [Time frame: Baseline, 1 and 2 years]
- Temperature [Time frame: Baseline, 1 and 2 years]
- Drug, alcohol, and smoking history [Time frame: Baseline, 1 and 2 years]
- Nicotine dependency [Time frame: Baseline, 1 and 2 years]
- Health anamnesis [Time frame: Baseline, 1 and 2 years]
- Presence and quantification of specific periodontal pathogens [Time frame: Baseline, 1 and 2 years]
Eligibility criteria
Inclusion criteria
- 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)
Exclusion criteria
- Patients fitting to all the above inclusion criteria will be excluded from the study if unable to attend to the study-related procedures.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Spain · 2 centers
- Faculty of Dentistry, University Complutense of Madrid (UCM) — Madrid
- Faculty of Dentistry, University Complutense of Madrid (UCM) — Madrid
Identifiers
NCT: NCT07167771 · 165-290725