PREDICTIVE ABILITY OF A PANEL OF BIOMARKERS IN SALIVA IN HEALTHY AND PERIODONTALLY AFFECTED SUBJECTS

Study Overview
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Brief Summary
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Objective: The main aim of this cross-sectional clinical study is to evaluate the predictive ability of a panel of salivary biomarkers in determining periodontal health status. Material and methods: In this observational, cross-sectional study patients attending consecutively to the Periodontal Postgraduate Clinic at the University Complutense of Madrid. The participants will be categorized into different periodontal health status groups based on the 2018 classification of periodontal diseases, including periodontally healthy, gingivitis, treated periodontitis (stable/unstable), and various stages of periodontitis. During the screening visit, participants will undergo a comprehensive medical examination to gather relevant health information, including age, gender, weight, height, waist circumference, and drug, alcohol, and smoking history. Additionally, clinical assessments, saliva samples and microbiological parameters will be recorded. A convenience sample of 100 subjects will be recruited for this pilot study with the objective to generate data for the multivariate predictive analysis. 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

Official Title
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CROSS SECTIONAL CLINICAL STUDY TO DETERMINE THE PREDICTIVE ABILITY OF A PANEL OF BIOMARKERS IN SALIVA IN HEALTHY AND PERIODONTALLY AFFECTED SUBJECTS. PILOT STUDY

Conditions
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Periodontitis, Saliva, Biomarkers

Intervention / Treatment
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* Diagnostic Test: Salivaru biomarkers


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: 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) 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 or if one or more of the following systemic or local exclusion criteria will be found at any time through the study: Systemic exclusion criteria Un-controlled diabetes (HbA1c >7) Compromised general health status (≥ASA III); Drug abuse, alcohol abuse, or smoking > 10 cigarettes a day; Chronic use of corticosteroids, NSAIDs, or immune modulators (any type/dose); No recent Asthma, hayfever, allergies, severe intolerances Mouth piercing, xerostomia Pregnant or nursing women. Local exclusion criteria History of antibiotic intake within the last 30 days History of periodontal/mucogingival surgery within the last 6 months.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Periodontal health status<br>Categorized according to 2018 classification of periodontal diseases (Papapanou et al. 2018), including healthy, gingivitis, treated periodontitis (stable/unstable), periodontitis Stages I & II, and periodontitis Stages III and IV. | Diagnostic Test: Salivaru biomarkers<br>* C-reactive protein (CRP), triggering receptor expressed on myeloid cells-1 (TREM-1), interleukin (IL)-1beta, metalloproteinase (MMP)-8, IL-10, IL-6, monocyte chemoattractant protein-1 (MCP-1), Macrophage Inflammatory Protein-1 Alpha (MIP-1), interferon-gamma (IFN-gamma), osteoprotegerine (OPG), Receptor activator of nuclear factor kappa B ligand (RANKL), Tumor Necrosis Factor-Alpha (TNF-alpha)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Salivary biomarkers | Combination of C-reactive protein (CRP), triggering receptor expressed on myeloid cells-1 (TREM-1), interleukin (IL)-1beta, metalloproteinase (MMP)-8, IL-10, IL-6, monocyte chemoattractant protein-1 (MCP-1), Macrophage Inflammatory Protein-1 Alpha (MIP-1), interferon-gamma (IFN-gamma), osteoprotegerine (OPG), Receptor activator of nuclear factor kappa B ligand (RANKL), Tumor Necrosis Factor-Alpha (TNF-alpha). | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Age |  | Baseline | 
| Gender |  | Baseline | 
| Hb1Ac | using a point of care home use diagnostic test (A1CNow+; Bayer) | Baseline | 
| Finn-risk | diabetic risk questionnaire | Baseline | 
| Blood pressure |  | Baseline | 
| Patient's temperature | digital body thermometer | Baseline | 
| Habits | Drug, alcohol, and smoking history | Baseline | 
| Plaque index | Presence/Absence | Baseline | 
| Bleeding on probing | Presence/Absence | Baseline | 
| Suppuration on probing | Presence/Absence | Baseline | 
| Probing depth | Distance in mm between the bottom of the pocket and the gingival margin | Baseline | 
| Recession | Distance in mm between the amelocemental boundary and the gingival margin | Baseline | 
| Radiographic bone loss | Panoramic radiograph | Baseline | 
| Microbiological analyses | Presence and quantity of Porphyromonas gingivalis, Aggregatibacter actinomycetemcomitans and Tannerella forsythia | Baseline |