NCT07167771 LONGITUDINAL FOLLOW-UP STUDY TO DETERMINE THE PREDICTIVE ABILITY OF A PANEL OF BIOMARKERS IN SALIVA IN HEALTHY AND PERIODONTALLY AFFECTED PATIENTS
| NCT ID | NCT07167771 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universidad Complutense de Madrid |
| Condition | Periodontal Diseases |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-10-01 |
| Primary Completion | 2027-10 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2025-10-01 with a primary completion date of 2027-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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 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) 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07167771 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Periodontal Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07167771 currently recruiting?
Yes, NCT07167771 is actively recruiting participants. Contact the research team at elfiguer@ucm.es for enrollment information.
Where is the NCT07167771 trial being conducted?
This trial is being conducted at Madrid, Spain, Madrid, Spain.
Who is sponsoring the NCT07167771 clinical trial?
NCT07167771 is sponsored by Universidad Complutense de Madrid. The trial plans to enroll 100 participants.