PeriodontitisNCT07739732
Periodontitis on Gingival Crevicular Fluid Metobolomics
An observational study of Periodontitis, run by University of Catania at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- Periodontal probing depth
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 4 May 2026to 18 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients affected by periodontitis or healthy controls according to the 2018 new classification of periodontitis.
Who may be able to join
- 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.
Who cannot join
- Periodontal treatment during the previous 6 months.
- Use of antibiotics, non-steroidal anti-inflammatory drugs, or immunosuppressive agents during the previous 6 months.
- Pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
AOU Policlinico G. Rodolico
Catania, Italy, 95123
Gaetano Isola, 0953785652, gaetano.isola@unict.it
Rosalia Leonardi, 0953785652, rleonardi@unict.it
About this study
Official title: Impact of Periodontitis on Metabolomics in Gingival Crevicular Fluid
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.
Read the 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.
- Conditions
- Periodontitis
- Being tested
- Periodontal probing depth
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodontal probing depthOther
Periodontal probing depth measured in millimeters
| Study group | Role | What they receive |
|---|---|---|
| Periodontitis | Not described Receives: Other: Periodontal probing depth | |
| Healthy controls | Not described Receives: Other: Periodontal probing depth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing pocket depth
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start4 May 2026
- Primary completion16 Nov 2026 (estimated)
- Study completion18 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Catania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gaetano Isola, University of Catania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07739732
- Sponsor's protocol ID
- 102-26
- Status last verified
- Jul 2026
- First submitted
- 28 Jul 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study results
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Periodontitis on Metabolomics in Gingival Crevicular Fluid
- ClinicalTrials.gov ID
- NCT07739732
- Acronym / sponsor ID
- 102-26
- Conditions
- Periodontitis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of CataniaUniversity, hospital or other
- Study start
- 4 May 2026 (actual)
- Primary completion
- 16 Nov 2026 (estimated)
- Study completion
- 18 Dec 2026 (estimated)
- First posted
- 31 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Periodontitis | – | Other: Periodontal probing depth |
| Healthy controls | – | Other: Periodontal probing depth |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients affected by periodontitis or healthy controls according to the 2018 new classification of periodontitis.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Periodontal treatment during the previous 6 months.
- Use of antibiotics, non-steroidal anti-inflammatory drugs, or immunosuppressive agents during the previous 6 months.
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Periodontal probing depthPeriodontal probing depth measured in millimeters | Other | Healthy controls, Periodontitis |
Primary outcome
Probing pocket depth
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: Yes. Study results
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontitis, run by University of Catania at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gaetano Isola (0953785652, gaetano.isola@unict.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probing pocket depth (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.