Actively Recruiting

Age: 18Years - 70Years
All Genders
Healthy Volunteers
ID06480825

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

Led by University of Pisa · Updated on 2026-04-01

40

Participants Needed

2

Research Sites

126 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating the differences in gingival tissue between healthy individuals and those with gingivitis, a condition marked by gum inflammation caused by bacterial build-up. This observational study aims to assess the changes in the ultrastructure of gingival tissue during inflammation. Gingivitis is an important risk factor for periodontitis, and understanding tissue variations may improve knowledge about this condition. Participants with gingivitis and healthy controls will undergo ultra-high frequency ultrasonographic scans at 70 MHz to examine their gum tissues. Scans will be performed on three areas of each dental arch, including the front, middle right, and middle left sections. The study evaluates gingival thickness, tissue echogenicity, and vascularization through a resistive index to compare the two groups. During the study, participants will receive one ultrasonographic scan at enrollment. Researchers will measure echogenicity as the primary outcome and assess vascular parameters, tooth decay index (DMFT), probing pocket depth (PPD), full-mouth bleeding score (FMBS), and full-mouth plaque score (FMPS) as secondary outcomes. This study will continue until July 2028 and involves adults aged 18 to 70 years. Participants will provide informed consent and undergo assessments to monitor gum health.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Males or females aged over 18 years
  • Presence of at least 20 teeth
  • Full-mouth plaque score (FMPS) greater than 50%
  • Full-mouth bleeding score (FMBS) greater than 30%
  • Ability and willingness to give informed consent
Not Eligible

You will not qualify if you...

  • Pregnancy or breastfeeding
  • Use of anti-inflammatory drugs, statins, or local/systemic antibiotics within the last 30 days
  • Smoking habit
  • Dental or periodontal condition requiring immediate treatment
  • Refusal to be enrolled in the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 1 day

Participants undergo an ultra-high frequency ultrasonographic scan of gingival tissues and related assessments.

1 visit (in-person)

Trial Site Locations

Total: 2 locations

1

University of Pisa

Pisa, Italy, Italy, 56126

Actively Recruiting

2

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

Pisa, Italy

Actively Recruiting

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Research Team

R

Rossana Izzetti

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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