ClinicalTrials.gg
RecruitingNCT07167771FLOE_longUpdated Jun 29, 2026

LONGITUDINAL FOLLOW-UP STUDY TO DETERMINE THE PREDICTIVE ABILITY OF A PANEL OF BIOMARKERS IN SALIVA IN HEALTHY AND PERIODONTALLY AFFECTED PATIENTS

An observational study in Periodontal Diseases, sponsored by Universidad Complutense de Madrid. Recruiting at 2 sites in Spain. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-29.

Sponsored by Universidad Complutense de Madrid · Observational

From the registry’s dates

  • Started Oct 2025; still recruiting 1 year 1 month later.

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 26 studies in Periodontal Diseases with a site in Spain — 10 open to participants now, 10 under way, none of them phase 3. Periodontal Diseases · Spain.

Started
2025
with 1 other
Observational
8 of 26
2 open now
Registered
22nd of 26
by date
Lead sponsor
4 of 26
Universidad Complutense de Madrid

Among the 26 studies in Periodontal Diseases with a site in Spain, this one is one of 2 that started in 2025, is one of 8 observational ones, and was the 22nd registered.

Periodontal Diseases

867 studies on the registry are indexed under Periodontal Diseases; 189 are open to participants now.

Browse Periodontal Diseases studies →

Open to participants now

10 of the 26 studies in Periodontal Diseases with a site in Spain are open now. Recruiting first, the newest first:

4 more — sign in →

All 10 open studies →

A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →

Who these studies take

Of the 101 Periodontal Diseases studies recruiting now, 47 (47%) set no upper age limit and 42 (42%) stop at 75 or younger; 5 take children under 18; 58 take healthy volunteers.

This study: 18 Years and older · all sexes · healthy volunteers too.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 26 studies in Periodontal Diseases with a site in Spain, or all of them as a file.
02

Study summary

Objective: The main aim of this longitudinal clinical study is to evaluate the predictive ability of a panel of salivary biomarkers in determining periodontal health status in 2 years follow up in a group of healthy and periodontally affected individuals.

Material and methods: In this longitudinal, observational follow-up study, patients previously enrolled in a cross-sectional study at the Periodontal Postgraduate Clinic, University Complutense of Madrid, will be re-evaluated over a 2-year period. Participants (≥18 years) will be categorized into diagnostic groups based on the 2018 classification of periodontal diseases, including periodontally healthy, gingivitis, treated periodontitis (stable/unstable), and various stages of periodontitis. The study will include follow-up visits at 1 and 2 years. At each visit, participants will undergo a comprehensive medical examination to assess age, gender, weight, height, waist circumference, blood pressure, temperature, smoking and alcohol history, systemic health, and HbA1c levels. A periodontal examination will be performed at six sites per tooth, and clinical parameters including plaque, bleeding on probing, probing depth, recession, and tooth loss will be recorded. Saliva and subgingival plaque samples will be collected for biomarker and microbiological analysis. Salivary biomarkers will be measured using multiplex immunoassays, and bacterial quantification will be performed by multiplex qPCR. 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. For periodontitis cases, treatment response over time will be analyzed, with subgroup comparisons between responders and non-responders.

03

Conditions studied

  • Periodontal Diseases

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Keywords

  • periodontal diseases
  • saliva
  • biomarkers
  • prediction
  • periodontopathogens
  • interleukin 1
  • MMP-8
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

This study will be conducted as a 2y longitudinal, observational follow-up study, from a previous cross-sectional study (code 23/481-E). The study will be conducted at the Faculty of Dentistry University Complutense of Madrid, Spain. The research group and facilities associated with the university will serve as the primary study setting for participant recruitment, data collection, and analysis.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participants from the cohort involved in the previous cross-sectional study (code 23/481-E).
  • Adults (≥ 18-year-old)
  • Being able to sign an 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) in the previous cross-sectional study (code 23/481-E)

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Cohort 1

    Participants involved in an already done cross-sectional study (code 23/481-E).

    Other: No intervention

Interventions

  • OtherNo intervention

    There is not intervention in these patients, appart from their normal dental check-up visits.

06

What researchers measure

Primary outcomes

  1. Salivary biomarkers

    Concentrations of specific biomarkers (IL-1 and MMP-8) analyzed using multiplex commercial diagnostic tests.

    Time frame: Baseline, 1 and 2 years

Secondary outcomes

  1. Age

    Participant's age in years.

    Time frame: Baseline, 1 and 2 years

  2. Gender

    Gender

    Time frame: Baseline, 1 and 2 years

  3. Weight

    Weight (kg)

    Time frame: Baseline, 1 and 2 years

  4. Height

    Height (cm)

    Time frame: Baseline, 1 and 2 years

  5. Waist circumference

    A measuring tape will be used, and the determination will be made above the hip bone

    Time frame: Baseline, 1 and 2 years

  6. HbA1c

    Following the instructions from the manufacturer of the device (A1CNow+; Bayer) and diabetic risk questionnaire (Finn-risk)

    Time frame: Baseline, 1 and 2 years

  7. Blood pressure

    The procedure will follow the recommendations in the clinical practice guidelines of the American Heart Association (AHA) {Whelton, 2018 #466}. In summary, a validated and approved blood pressure monitor (Omron M6 COMFORT IT HEM-7322U-E) will be used with the patient seated, back straight, and arms supported at heart level. After the initial measurement, there will be a 5-minute rest period before taking a second reading. The average of the two readings will be considered valid.

    Time frame: Baseline, 1 and 2 years

  8. Temperature

    Participant's body temperature in degrees Celsius.

    Time frame: Baseline, 1 and 2 years

  9. Drug, alcohol, and smoking history

    History of participant's drug, alcohol, and smoking habits.

    Time frame: Baseline, 1 and 2 years

  10. Nicotine dependency

    Assessment of nicotine dependency using the Fagerström Test for Nicotine Dependence.

    Time frame: Baseline, 1 and 2 years

  11. Health anamnesis

    Relevant systemic health information collected through a complete health history questionnaire

    Time frame: Baseline, 1 and 2 years

  12. Presence and quantification of specific periodontal pathogens

    P. gingivalis, A. actinomycetemcomitans, T. forsythia detected through real time PCR analysis

    Time frame: Baseline, 1 and 2 years

  13. Plaque index

    categorized as presence/absence

    Time frame: Baseline, 1 and 2 years

  14. Bleeding on probing

    assessed dichotomously within 15 seconds after probing

    Time frame: Baseline, 1 and 2 years

  15. Suppuration on probing

    assessed dichotomously within 15 seconds after probing

    Time frame: Baseline, 1 and 2 years

  16. Probing depth

    defined as the distance in mm between the bottom of the pocket and the gingival margin

    Time frame: Baseline, 1 and 2 years

  17. Recession

    defined as the distance in mm between the amelocemental boundary and the gingival margin. The sum of probing depth and recession will determine the patient's clinical attachment loss

    Time frame: Baseline, 1 and 2 years

  18. Number of teeth lost and reason

    Number of teeth lost and reason

    Time frame: Baseline, 1 and 2 years

07

Study locations

2 of 2 sites recruiting
  • Faculty of Dentistry, University Complutense of Madrid (UCM)
    Madrid, 28040, Spain
    Recruiting
    • Elena Figuero Ruiz · Contactelfiguer@ucm.es · 0034913942186
    • Mariano Sanz, Prof. · Principal investigator
    • Elena Figuero, Prof. · Sub investigator
    • Patricia Padilla · Sub investigator
    • Claudia Sola · Sub investigator
    • Mª José Marín, Dr · Sub investigator
    • Eduardo Montero, Dr · Sub investigator
  • Faculty of Dentistry, University Complutense of Madrid (UCM)
    Madrid, 28040, Spain
    Recruiting
    • Elena Figuero, Prof. · Contactelfiguer@ucm.es · 0034913942186
    • Claudia Sola, PhD student · Sub investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2025 (actual). Primary completion is estimated for Oct 2027, 24 months after the start.

Of 79 non-industry observational studies under Periodontal Diseases, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 30. This study's planned 24 months is above that.

Counting every sponsor, half of 83 studies reached it within 13 months; a quarter within 7 and three quarters within 32.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 4, 2025
First posted
Sep 11, 2025
StartActual
Oct 1, 2025
Primary completionEst.
Oct 2027
CompletionEst.
Oct 2028
Last update
Jun 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07167771
Responsible party
Sponsor
First posted
Sep 11, 2025
Start date
Oct 1, 2025
Primary completion
Oct 2027 (estimated)
Completion
Oct 2028 (estimated)
Last update
Jun 29, 2026

Study contacts

Elena Figuero, Prof.
Contact
elfiguer@ucm.es
+34 913942186
Mariano Sanz, Prof.
Contact
marsan@ucm.es
+34 913942021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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