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

February 12, 2025 updated by: Gaetano Isola, University of Catania

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)

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Catania, Italy, 95100
        • Policlinico G. Rodolico

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)
Analysis of Line-Field Confocal Optical Coherence Tomography (LC-OCT) in separate groups of patients with gingivitis, periodontitis and healthy patients
Other Names:
  • Line-Field Confocal Optical Coherence Tomography (LC-OCT) in all patients
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)
Analysis of Line-Field Confocal Optical Coherence Tomography (LC-OCT) in separate groups of patients with gingivitis, periodontitis and healthy patients
Other Names:
  • Line-Field Confocal Optical Coherence Tomography (LC-OCT) in all patients
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)
Analysis of Line-Field Confocal Optical Coherence Tomography (LC-OCT) in separate groups of patients with gingivitis, periodontitis and healthy patients
Other Names:
  • Line-Field Confocal Optical Coherence Tomography (LC-OCT) in all patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual epithelial surface change
Time Frame: 6-months
Analysis of disruption of superficial epithelium and basal line
6-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Catania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2025

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

February 12, 2025

First Submitted That Met QC Criteria

February 12, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 12, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-3307

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Study results

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gingival Diseases

Clinical Trials on Line-Field Confocal Optical Coherence Tomography (LC-OCT)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mongolia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe