Gingival DiseasesPerio-LC-OCTNCT06831487
Analysis of Line-Field Confocal Optical Coherence Tomography (LC-OCT) in Characterization of Gingival Systemic Health, Gingivitis and Periodontitis
A study testing Line-Field Confocal Optical Coherence Tomography (LC-OCT) in people with Gingival Diseases, run by University of Catania at 1 site in Italy.
Trial summary
The aim of the study is to identify tissue changes among healthy patients, patients with gingivitis and with periodontitis before and after treatment, by analyzing tissues changes through Line-Field Confocal Optical Coherence Tomography (LC-OCT) Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gingival Diseases
- What is being tested?
- Line-Field Confocal Optical Coherence Tomography (LC-OCT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 2 Jan 2025to 30 Jun 2025
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of gingivitis or periodontitis by the presence of elevated bleeding or probing index or probing pocket depth
Who cannot join
- Smoking
- Any systemic diseases that could influence the gingival structure
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Analysis of Line-Field Confocal Optical Coherence Tomography (LC-OCT) in the Characterization of Gingival Systemic Health, Gingivitis and Periodontitis and Effects of Periodontal Treatment
The aim of the study is to identify tissue changes among healthy patients, patients with gingivitis and with periodontitis before and after treatment, by analyzing tissues changes through Line-Field Confocal Optical Coherence Tomography (LC-OCT)
Read the detailed description
The tissue changes among healthy patients, patients with gingivitis and with periodontitis before and after treatment, by analyzing tissues changes through Line-Field Confocal Optical Coherence Tomography (LC-OCT) will be evaluated through changes on epithelium before and after non surgical periodontal treatment
- Conditions
- Gingival Diseases
- Being tested
- Line-Field Confocal Optical Coherence Tomography (LC-OCT)
- Keywords
- Periodontitis, gingivitis, LC-OCT
- Medical subject headings
- Gingival Diseases, Periodontitis, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Line-Field Confocal Optical Coherence Tomography (LC-OCT)Device
Also called Line-Field Confocal Optical Coherence Tomography (LC-OCT) in all patients
Analysis of Line-Field Confocal Optical Coherence Tomography (LC-OCT) in separate groups of patients with gingivitis, periodontitis and healthy patients
| Study group | Role | What they receive |
|---|---|---|
| Analysis of Line-Field Confocal Optical Coherence Tomography (LC-OCT) in gingivitis | Active comparator | Analysis of tissue changes pre and post non surgical periodontal treatment using Line-Field Confocal Optical Coherence Tomography (LC-OCT) in gingivitis patients Receives: Device: Line-Field Confocal Optical Coherence Tomography (LC-OCT) |
| Line-Field Confocal Optical Coherence Tomography (LC-OCT) periodontitis | Active comparator | Line-Field Confocal Optical Coherence Tomography (LC-OCT) in periodontitis patients Receives: Device: Line-Field Confocal Optical Coherence Tomography (LC-OCT) |
| Line-Field Confocal Optical Coherence Tomography (LC-OCT) - Healthy patients | Placebo comparator | Analysis of Line-Field Confocal Optical Coherence Tomography (LC-OCT) in healthy patients Receives: Device: Line-Field Confocal Optical Coherence Tomography (LC-OCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual epithelial surface change
Analysis of disruption of superficial epithelium and basal line
Measured: 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start2 Jan 2025
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival DiseasesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Independently, patients with gingivitis, periodontitis and healthy patients will be evaluated
- Masking
- None (open label)
- 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
- NCT06831487
- Sponsor's protocol ID
- 2024-3307
- Acronym
- Perio-LC-OCT
- Status last verified
- Feb 2025
- First submitted
- 12 Feb 2025
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Study results
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Line-Field Confocal Optical Coherence Tomography (LC-OCT) in the Characterization of Gingival Systemic Health, Gingivitis and Periodontitis and Effects of Periodontal Treatment
- ClinicalTrials.gov ID
- NCT06831487
- Acronym / sponsor ID
- Perio-LC-OCT / 2024-3307
- Conditions
- Gingival Diseases
- Keywords
- Periodontitis, gingivitis, LC-OCT
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of CataniaUniversity, hospital or other
- Study start
- 2 Jan 2025 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 18 Feb 2025 (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.
The aim of the study is to identify tissue changes among healthy patients, patients with gingivitis and with periodontitis before and after treatment, by analyzing tissues changes through Line-Field Confocal Optical Coherence Tomography (LC-OCT)
Detailed description
The tissue changes among healthy patients, patients with gingivitis and with periodontitis before and after treatment, by analyzing tissues changes through Line-Field Confocal Optical Coherence Tomography (LC-OCT) will be evaluated through changes on epithelium before and after non surgical periodontal treatment
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Independently, patients with gingivitis, periodontitis and healthy patients will be evaluated
| Arm | Type | Receives |
|---|---|---|
| Analysis of Line-Field Confocal Optical Coherence Tomography (LC-OCT) in gingivitis | Active comparator | Device: Line-Field Confocal Optical Coherence Tomography (LC-OCT)Analysis of tissue changes pre and post non surgical periodontal treatment using Line-Field Confocal Optical Coherence Tomography (LC-OCT) in gingivitis patients |
| Line-Field Confocal Optical Coherence Tomography (LC-OCT) periodontitis | Active comparator | Device: Line-Field Confocal Optical Coherence Tomography (LC-OCT)Line-Field Confocal Optical Coherence Tomography (LC-OCT) in periodontitis patients |
| Line-Field Confocal Optical Coherence Tomography (LC-OCT) - Healthy patients | Placebo comparator | Device: Line-Field Confocal Optical Coherence Tomography (LC-OCT)Analysis of Line-Field Confocal Optical Coherence Tomography (LC-OCT) in healthy patients |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of gingivitis or periodontitis by the presence of elevated bleeding or probing index or probing pocket depth
Key exclusion criteria (2 listed)
- Smoking
- Any systemic diseases that could influence the gingival structure
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 |
|---|---|---|
| Line-Field Confocal Optical Coherence Tomography (LC-OCT)Also: Line-Field Confocal Optical Coherence Tomography (LC-OCT) in all patientsAnalysis of Line-Field Confocal Optical Coherence Tomography (LC-OCT) in separate groups of patients with gingivitis, periodontitis and healthy patients | Device | Analysis of Line-Field Confocal Optical Coherence Tomography (LC-OCT) in gingivitis, Line-Field Confocal Optical Coherence Tomography (LC-OCT) - Healthy patients, Line-Field Confocal Optical Coherence Tomography (LC-OCT) periodontitis |
Primary outcome
Visual epithelial surface change
Time frame: 6-months
Analysis of disruption of superficial epithelium and basal line
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 18 Feb 2025.
- Individual participant dataSharing planned: Undecided. 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Line-Field Confocal Optical Coherence Tomography (LC-OCT) in people with Gingival Diseases, 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 1 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 18 Feb 2025. 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual epithelial surface change (time frame: 6-months). 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 18 Feb 2025.