NCT07739732

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
5mo left

Started May 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress39%
May 2026Dec 2026

Study Start

First participant enrolled

May 4, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 31, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2026

Last Updated

July 31, 2026

Status Verified

July 1, 2026

Enrollment Period

7 months

First QC Date

July 28, 2026

Last Update Submit

July 28, 2026

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (1)

  • Probing pocket depth

    Baseline

Study Arms (2)

Periodontitis

Other: Periodontal probing depth

Healthy controls

Other: Periodontal probing depth

Interventions

Periodontal probing depthOTHER

Periodontal probing depth measured in millimeters

Healthy controlsPeriodontitis

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients affected by periodontitis or healthy controls according to the 2018 new classification of periodontitis.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AOU Policlinico G. Rodolico

Catania, Italy, 95123, Italy

RECRUITING

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Central Study Contacts

Gaetano Isola

CONTACT

0953785652gaetano.isola@unict.it

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

July 28, 2026

First Posted

July 31, 2026

Study Start

May 4, 2026

Primary Completion (Estimated)

November 16, 2026

Study Completion (Estimated)

December 18, 2026

Last Updated

July 31, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will share

Study results

Shared Documents
STUDY PROTOCOL
Time Frame
1 year
Access Criteria
Pubmed
More information

Locations

IT(1)