NCT06831487

Brief 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)

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 12, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 18, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

February 18, 2025

Status Verified

February 1, 2025

Enrollment Period

6 months

First QC Date

February 12, 2025

Last Update Submit

February 12, 2025

Conditions

Gingival Diseases

Keywords

Periodontitis, gingivitis, LC-OCT

Outcome Measures

Primary Outcomes (1)

  • Visual epithelial surface change

    Analysis of disruption of superficial epithelium and basal line

    6-months

Study Arms (3)

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

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

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

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

Interventions

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

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
Analysis of Line-Field Confocal Optical Coherence Tomography (LC-OCT) in gingivitisLine-Field Confocal Optical Coherence Tomography (LC-OCT) - Healthy patientsLine-Field Confocal Optical Coherence Tomography (LC-OCT) periodontitis

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Policlinico G. Rodolico

Catania, Italy, 95100, Italy

Location

MeSH Terms

Conditions

Gingival DiseasesPeriodontitisGingivitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesInfections

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: Independently, patients with gingivitis, periodontitis and healthy patients will be evaluated
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 12, 2025

First Posted

February 18, 2025

Study Start

January 2, 2025

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

February 18, 2025

Record last verified: 2025-02

Locations

IT(1)