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PeriodontitisFLOENCT06047132

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

An observational study of Periodontitis and Saliva, run by Universidad Complutense de Madrid at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Periodontitis, Saliva, Biomarkers
What is being tested?
Salivaru biomarkers
Type of treatment
Injection or infusion
How many people
100 participants
Where
1 siteSpain
Study dates
23 Oct 2023to 30 Jun 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

Who may be able to join

  • 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)

Who cannot join

  • 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);
Show all 12Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Faculty of Dentistry, University Complutense of Madrid (UCM)

    Madrid, Madrid, 28040

Other trials in Spain

About this study

Official 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

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

Being tested
Salivaru biomarkers
Medical subject headings
Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Salivaru biomarkersDiagnostic 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)

Study groups in NCT06047132
Study groupRoleWhat they receive
Periodontal health statusCategorized 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.
Receives: Diagnostic Test: Salivaru biomarkers

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Baseline

Secondary outcomes (14)

  1. Age

    Measured: Baseline

  2. Gender

    Measured: Baseline

  3. Hb1Ac

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

    Measured: Baseline

  4. Finn-risk

    diabetic risk questionnaire

    Measured: Baseline

  5. Blood pressure

    Measured: Baseline

  6. Patient's temperature

    digital body thermometer

    Measured: Baseline

  7. Habits

    Drug, alcohol, and smoking history

    Measured: Baseline

  8. Plaque index

    Presence/Absence

    Measured: Baseline

  9. Bleeding on probing

    Presence/Absence

    Measured: Baseline

  10. Suppuration on probing

    Presence/Absence

    Measured: Baseline

  11. Probing depth

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

    Measured: Baseline

  12. Recession

    Distance in mm between the amelocemental boundary and the gingival margin

    Measured: Baseline

  13. Radiographic bone loss

    Panoramic radiograph

    Measured: Baseline

  14. Microbiological analyses

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

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2023
  2. Study start23 Oct 2023
  3. Primary completion30 Jun 2024
  4. Study completion30 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06047132
Sponsor's protocol ID
110-110923
Acronym
FLOE
Status last verified
Dec 2024
First submitted
14 Sep 2023
Last updated
26 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Periodontitis and Saliva, run by Universidad Complutense de Madrid at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Salivary biomarkers (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06047132.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.

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