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

NCT ID: NCT06831487

Last Updated: 2025-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-02

Study Completion Date

2025-06-30

Brief Summary

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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

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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

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Gingival Diseases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Independently, patients with gingivitis, periodontitis and healthy patients will be evaluated
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

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

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

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

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

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

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

Group Type PLACEBO_COMPARATOR

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

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Other Intervention Names

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

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Catania

OTHER

Sponsor Role lead

Responsible Party

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Gaetano Isola

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Policlinico G. Rodolico

Catania, Italy, Italy

Site Status

Countries

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Italy

Other Identifiers

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2024-3307

Identifier Type: -

Identifier Source: org_study_id

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