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Completed

NCT Number: NCT06047132

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Dentistry, University Complutense of Madrid (UCM)

Madrid, 28040, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Salivaru biomarkers

Diagnostic Test

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)

Primary outcomes

  1. Salivary biomarkers

    Time frame: 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 outcomes

  1. Age

    Time frame: Baseline

  2. Gender

    Time frame: Baseline

  3. Hb1Ac

    Time frame: Baseline

    using a point of care home use diagnostic test (A1CNow+; Bayer)

  4. Finn-risk

    Time frame: Baseline

    diabetic risk questionnaire

  5. Blood pressure

    Time frame: Baseline

  6. Patient's temperature

    Time frame: Baseline

    digital body thermometer

  7. Habits

    Time frame: Baseline

    Drug, alcohol, and smoking history

  8. Plaque index

    Time frame: Baseline

    Presence/Absence

  9. Bleeding on probing

    Time frame: Baseline

    Presence/Absence

  10. Suppuration on probing

    Time frame: Baseline

    Presence/Absence

  11. Probing depth

    Time frame: Baseline

    Distance in mm between the bottom of the pocket and the gingival margin

  12. Recession

    Time frame: Baseline

    Distance in mm between the amelocemental boundary and the gingival margin

  13. Radiographic bone loss

    Time frame: Baseline

    Panoramic radiograph

  14. Microbiological analyses

    Time frame: Baseline

    Presence and quantity of Porphyromonas gingivalis, Aggregatibacter actinomycetemcomitans and Tannerella forsythia

Sponsors and collaborators

Lead sponsor

Universidad Complutense de Madrid

Other

Registry information

Official study title

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

Acronym: FLOE

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 21, 2023
Registry last updated
Jun 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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