Clinical trial Recruiting at 2 sites Observational Ages 18 to 70

Using ultra-high frequency ultrasound to study gum tissue in healthy individuals and those with gingivitis

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

Run by University of Pisa · NCT06480825 · Data updated 2026-11-12

This study is testing how ultra-high frequency ultrasound can help us see the differences in gum tissue between healthy people and those with gingivitis.

More Periodontitis trials

Quick facts

Study typeObservational
Ages18 Years to 70 Years
SexAll
Enrollment40 (estimated)
SponsorUniversity of Pisa
Academic / other
Locations2 sites (Pisa, Italy and 1 other locations)
StatusRecruiting
StartedApril 2, 2024
Main results expectedJanuary 31, 2026
Study endsJuly 2028
Registry record updatedApril 1, 2026
Trial IDNCT06480825 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include males and females over 18 years old with at least 20 teeth and significant plaque accumulation.

Probably not a fit

Patients who are pregnant, breastfeeding, or currently undergoing treatment with anti-inflammatory drugs or antibiotics may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to compare the clinical aspects of gingival tissue between healthy individuals and patients suffering from gingivitis. Participants will undergo ultra-high frequency ultrasonographic scans to assess various parameters of gingival tissue, including thickness, echogenicity, and vascularization. The study will enroll both healthy controls and patients with gingivitis, focusing on the ultrastructural variations associated with inflammation. The scans will be performed on three areas of the dental arch to gather comprehensive data.

Why it matters

Potential benefit: If successful, this study could enhance the understanding of gingival inflammation and improve diagnostic methods for periodontal diseases.

How similar studies have gone: While the use of ultrasonography in periodontal research is established, this specific application of ultra-high frequency ultrasound is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

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

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.