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

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

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

Study Overview

• Status: Recruiting
• Conditions: Periodontitis; Biomarkers; Saliva
• Intervention / Treatment: Diagnostic test: Salivaru biomarkers

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Elena Figuero; Phone Number: 003491392186; Email: elfiguer@ucm.es
• Study Contact Backup: Name: Mariano Sanz Alonso; Phone Number: 0034913942010; Email: marsan@ucm.es

Study Locations

• Spain
  • Madrid, Spain, 28040
    • Recruiting
    • Faculty of Dentistry, University Complutense of Madrid (UCM)
    • Contact: Elena Figuero Ruiz; Phone Number: 0034913942186; Email: elfiguer@ucm.es
    • Principal Investigator: Mariano Sanz, Prof.
    • Sub-Investigator: Elena Figuero, Prof.
    • Sub-Investigator: Marta Amigo
    • Sub-Investigator: Claudia Sola
    • Sub-Investigator: Mª José Marín, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The study population will be selected from those attending in a consecutive manner to the Periodontal Postgraduate Clinic at the University Complutense of Madrid

Description

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:

1. 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.

2. Local exclusion criteria

   • History of antibiotic intake within the last 30 days
   • History of periodontal/mucogingival surgery within the last 6 months.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Periodontal health status; 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; 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)

What is the study measuring?

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
Gender		Baseline
Age		Baseline
Blood pressure		Baseline
Hb1Ac	using a point of care home use diagnostic test (A1CNow+; Bayer)	Baseline
Finn-risk	diabetic risk questionnaire	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

Collaborators and Investigators

• Sponsor: Universidad Complutense de Madrid

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: September 14, 2023
• First Submitted That Met QC Criteria: September 14, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis
• Other Study ID Numbers: 110-110923

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No