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Recruiting NCT07739732

Periodontitis on Gingival Crevicular Fluid Metobolomics

Observational Periodontitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Periodontal probing depth.
Who it may be relevant to
Registry conditions: Periodontitis. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Impact of Periodontitis on Metabolomics in Gingival Crevicular Fluid

Overview

This cross-sectional observational study will compare the gingival crevicular fluid metabolomic profile of 30 adults with periodontitis and 30 periodontally healthy adults. Participants will undergo a periodontal examination and gingival crevicular fluid collection during a single study visit. Targeted metabolomic analysis will be used to identify differences between the two groups and associations with periodontal clinical parameters.

Detailed description

Sixty adults will be enrolled: 30 with periodontitis and 30 with periodontal health. Gingival crevicular fluid will be collected using four sterile absorbent paper strips inserted sequentially into the deepest eligible periodontal site or gingival sulcus. The strips will be pooled in a coded tube and stored immediately at -20 °C. Blood-contaminated samples will be discarded. Laboratory personnel will be blinded to group allocation. Targeted metabolomic findings will be compared between groups and correlated with periodontal clinical parameters.

Interventions

  • Other Periodontal probing depth
    Periodontal probing depth measured in millimeters

Primary outcome measures

  • Probing pocket depth [Time frame: Baseline]

Eligibility criteria

Inclusion criteria

  • Age between 18 and 70 years.
  • Ability to understand the study procedures and provide written informed consent.
  • For the periodontitis group: diagnosis of periodontitis according to the 2018 classification of periodontal diseases.
  • For the healthy control group: periodontal health according to the 2018 classification, with no current diagnosis or history of periodontitis.

Exclusion criteria

  • Periodontal treatment during the previous 6 months.
  • Use of antibiotics, non-steroidal anti-inflammatory drugs, or immunosuppressive agents during the previous 6 months.
  • Pregnancy.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Italy · 1 center
  • AOU Policlinico G. Rodolico — Catania

Identifiers

NCT: NCT07739732 · 102-26

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗