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

Active, not recruiting

• Conditions: Periodontitis; Biomarkers; Saliva
• Interventions: Diagnostic Test: Salivaru biomarkers

• Registration Number: NCT06047132
• Lead Sponsor: Universidad Complutense de Madrid

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-14
• Study First Submitted QC: 2023-09-14
• Study First Posted: 2023-09-21
• Study Start: 2023-10-23
• Primary Completion: 2024-06-30
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-11
• Last Update Posted: 2024-12-12
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Periodontal health status	Salivaru biomarkers	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.

Primary Outcome Measures

Name	Time	Method
Salivary biomarkers	Baseline	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).

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Faculty of Dentistry, University Complutense of Madrid (UCM); 🇪🇸 Madrid, Spain