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

March 31, 2026 updated by: Rossana Izzetti, University of Pisa

Ulta-High Frequency Ultrasound Assessment of Normal Versus Gingivitis Affected Gingival Tissues

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

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

Study Contact

Study Locations

  • Italy
      • Pisa, Italy
        • Recruiting
        • Department of Surgical, Medical and Molecular Pathology and Critical Care Medicine, University Hospital of Pisa
        • Contact:
    • Italy
      • Pisa, Italy, Italy, 56126
        • Recruiting
        • University of Pisa
        • Contact:
        • Principal Investigator:
          • Rossana Izzetti

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

Yes

Sampling Method

Non-Probability Sample

Study Population

Consecutive patients referred to the Sub-Unit of Periodontology, Halitosis, and Periodontal Medicine of the Unit of Dentistry and Oral Surgery at the University Hospital of Pisa will be enrolled.

Description

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

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Gingivitis group
patients affected by gingivitis
Other: Performance of ultrasonographic scan
Ultra-high frequency ultrasonographic scan of gingival tissues
Control group
Periodontally healthy patients
Other: Performance of ultrasonographic scan
Ultra-high frequency ultrasonographic scan of gingival tissues

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Echogenicity
Time Frame: measured once at enrollemnt
Variations in echogenicity assessed through grey levels distribution between healthy patients versus gingivitis
measured once at enrollemnt

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vascular parameters
Time Frame: measured once at enrollemnt
Variations in vascularization assessed through grey levels distribution between healthy patients versus gingivitis
measured once at enrollemnt
DMFT
Time Frame: measured once at enrollement
The Decayed-Missing-Filled Teeth (DMFT) index, categorized as Low (0-4), Moderate (5-13), and High (14+), will evaluate overall dental health.
measured once at enrollement
PPD
Time Frame: measured once at enrollement
Probing Pocket Depth (PPD) will be measured using a UNC-15 periodontal probe with 0.3 N pressure, recording six sites per tooth (distobuccal, buccal, mesiobuccal, distolingual, lingual, mesiolingual), rounded to the nearest millimeter.
measured once at enrollement
FMBS
Time Frame: measured once at enrollement
Full Mouth Bleeding Score (FMBS) will be determined dichotomously post-probing.
measured once at enrollement
FMPS
Time Frame: measured once at enrollement
Full Mouth Plaque Score (FMPS) will assess plaque presence on each tooth surface, with scores of 1 for presence and 0 for absence across six sites per tooth.
measured once at enrollement

Collaborators and Investigators

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

Sponsor

University of Pisa

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)

April 2, 2024

Primary Completion (Actual)

January 31, 2026

Study Completion (Estimated)

July 1, 2028

Study Registration Dates

First Submitted

June 24, 2024

First Submitted That Met QC Criteria

June 24, 2024

First Posted (Actual)

June 28, 2024

Study Record Updates

Last Update Posted (Actual)

April 1, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7935870439

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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