Using ultra-high frequency ultrasound to study gum tissue in healthy individuals and those with gingivitis
Ulta-High Frequency Ultrasound Assessment of Normal Versus Gingivitis Affected Gingival Tissues
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 |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University of Pisa Academic / other |
| Locations | 2 sites (Pisa, Italy and 1 other locations) |
| Trial ID | NCT06480825 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include males and females over 18 years old with at least 20 teeth and significant plaque accumulation.
Not a fit: Patients who are pregnant, breastfeeding, or currently undergoing treatment with anti-inflammatory drugs or antibiotics may not benefit from this study.
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 performed: While the use of ultrasonography in periodontal research is established, this specific application of ultra-high frequency ultrasound is relatively novel.
Eligibility criteria
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 this trial is running
Pisa, Italy and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.