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

NCT07167771 | Not Yet Recruiting

• 1 other identifier: 165-290725
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Periodontal Diseases

Keywords

periodontal diseases; saliva; biomarkers; prediction; periodontopathogens; interleukin 1; MMP-8

Outcome Measures

Primary Outcomes (1)

• Salivary biomarkers

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

  Baseline, 1 and 2 years

Secondary Outcomes (18)

• Age

  Baseline, 1 and 2 years

• Gender

  Baseline, 1 and 2 years

• Weight

  Baseline, 1 and 2 years

• Height

  Baseline, 1 and 2 years

• Waist circumference

  Baseline, 1 and 2 years

Study Arms (1)

Cohort 1

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

Other: No intervention

Interventions

No intervention OTHER

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

Cohort 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Participants from the cohort involved in the previous cross-sectional study (code 23/481-E).
• 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) in the previous cross-sectional study (code 23/481-E)

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead

Study Sites (1)

Faculty of Dentistry, University Complutense of Madrid (UCM)

Madrid, 28040, Spain

Location

Biospecimen

Retention: SAMPLES WITH DNA

Saliva samples Samples from gingival crevicular fluid

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Elena Figuero, Prof.

CONTACT

+34 913942186; elfiguer@ucm.es

Mariano Sanz, Prof.

CONTACT

+34 913942021; marsan@ucm.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2025
• First Posted: September 11, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2028
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)