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Enrolling by invitationNCT06831487Perio-LC-OCTUpdated Feb 18, 2025

Analysis of Line-Field Confocal Optical Coherence Tomography (LC-OCT) in Characterization of Gingival Systemic Health, Gingivitis and Periodontitis

An interventional study of Line-Field Confocal Optical Coherence Tomography (LC-OCT) in Gingival Diseases, sponsored by University of Catania. Enrolling by invitation at 1 site in Italy. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-02-18.

Sponsored by University of Catania · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 3 months ago, but the record still lists the study as enrolling by invitation.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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 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

02

Conditions studied

  • Gingival Diseases

Keywords

  • Periodontitis, gingivitis, LC-OCT
03

In context

Gingival Diseases

86 studies on the registry are indexed under Gingival Diseases; 25 are open to participants now.

This study's planned enrollment of 60 is above the median of 52 across 69 interventional studies indexed under Gingival Diseases.

Browse Gingival Diseases studies →

Lead sponsor

University of Catania is the lead sponsor of 71 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Diagnosis of gingivitis or periodontitis by the presence of elevated bleeding or probing index or probing pocket depth

Exclusion criteria

Exclusion Criteria:

  • Smoking
  • Any systemic diseases that could influence the gingival structure
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    Analysis of Line-Field Confocal Optical Coherence Tomography (LC-OCT) in gingivitis

    Analysis of tissue changes pre and post non surgical periodontal treatment using Line-Field Confocal Optical Coherence Tomography (LC-OCT) in gingivitis patients

    Device: Line-Field Confocal Optical Coherence Tomography (LC-OCT)

  • Active comparator
    Line-Field Confocal Optical Coherence Tomography (LC-OCT) periodontitis

    Line-Field Confocal Optical Coherence Tomography (LC-OCT) in periodontitis patients

    Device: Line-Field Confocal Optical Coherence Tomography (LC-OCT)

  • Placebo comparator
    Line-Field Confocal Optical Coherence Tomography (LC-OCT) - Healthy patients

    Analysis of Line-Field Confocal Optical Coherence Tomography (LC-OCT) in healthy patients

    Device: Line-Field Confocal Optical Coherence Tomography (LC-OCT)

Interventions

  • DeviceLine-Field Confocal Optical Coherence Tomography (LC-OCT)

    Analysis of Line-Field Confocal Optical Coherence Tomography (LC-OCT) in separate groups of patients with gingivitis, periodontitis and healthy patients

    Also known as: Line-Field Confocal Optical Coherence Tomography (LC-OCT) in all patients

06

What researchers measure

Primary outcomes

  1. Visual epithelial surface change

    Analysis of disruption of superficial epithelium and basal line

    Time frame: 6-months

07

Study locations

1 site
  • Policlinico G. Rodolico
    Catania, Italy 95100, Italy
08

References and documents

Individual participant data

Plan to share: Undecided — Study results

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06831487
Lead sponsor
University of Catania
Responsible party
Gaetano Isola (Associate Professor, University of Catania) — Principal investigator
First posted
Feb 18, 2025
Start date
Jan 2, 2025
Primary completion
Jun 30, 2025 (estimated)
Completion
Jun 30, 2025 (estimated)
Last update
Feb 18, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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