Application of Ultra-high Frequency Ultrasonography (UHFUS) to the Study of Gingival Tissues

NCT ID: NCT06480825

Last Updated: 2025-04-01

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-02

Study Completion Date

2025-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Gingival inflammation triggered by the accumulation of bacterial is the primary risk factor for the development of periodontitis. Clinically, localized signs of inflammation limited to the gingiva, presence of significant bacterial plaque load, and stable attachment levels on the periodontium can be observed in course of gingivitis. The aim of the present study is to compare clinical aspects of gingival tissue in healthy patients versus patients with gingivitis to assess the ultrastructural variations present in course of inflammation.

Patients with gingivitis and healthy controls will be enrolled. All patients will undergo ultra-high frequency ultrasonographic scans (70 MHz) of gingival tissue on three areas per dental arch (anterior, middle right, middle left). Gingival thickness, echogenicity, and vascularization assessed through resisitive index will be evaluated.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gingivitis Periodontitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Gingivitis group

patients affected by gingivitis

Performance of ultrasonographic scan

Intervention Type OTHER

Ultra-high frequency ultrasonographic scan of gingival tissues

Control group

Periodontally healthy patients

Performance of ultrasonographic scan

Intervention Type OTHER

Ultra-high frequency ultrasonographic scan of gingival tissues

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Performance of ultrasonographic scan

Ultra-high frequency ultrasonographic scan of gingival tissues

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* males or females of age \> 18 years
* presence of at least 20 teeth
* full-mouth plaque score (FMPS) \>50%
* FMBS \>30%
* ability and willingness to give informed consent

Exclusion Criteria

* pregnancy or breastfeeding
* pharmacological treatment with antinflammatory drugs, statins, or either local or systemic antibiotics (within the previous 30 days)
* smoking habit
* dental or periodontal condition requiring immediate treatment
* refusal to be enrolled in the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Pisa

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Rossana Izzetti

Principal Investigator, Researcher at the Department of Surgical, Medical and Molecular Pathology and Critical Care Medicine of the University of Pisa

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Pisa

Pisa, , Italy

Site Status RECRUITING

Department of Surgical, Medical and Molecular Pathology and Critical Care Medicine, University Hospital of Pisa

Pisa, , Italy

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Italy

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Rossana Izzetti

Role: CONTACT

3475205619

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Rossana Izzetti

Role: primary

+39050993037

Rossana Izzetti

Role: primary

3475205619

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

7935870439

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.