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.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | University of Pisa Academic / other |
| Locations | 2 sites (Pisa, Italy and 1 other locations) |
| Status | Recruiting |
| Started | April 2, 2024 |
| Main results expected | January 31, 2026 |
| Study ends | July 2028 |
| Registry record updated | April 1, 2026 |
| Trial ID | NCT06480825 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
- Study coordinator: Rossana Izzetti
- Email: rossana.izzetti@unipi.it
- Phone: 3475205619
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.