NCT06480825 Application of Ultra-high Frequency Ultrasonography (UHFUS) to the Study of Gingival Tissues
| NCT ID | NCT06480825 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Pisa |
| Condition | Gingivitis |
| Study Type | OBSERVATIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-04-02 |
| Primary Completion | 2026-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 40 participants in total. It began in 2024-04-02 with a primary completion date of 2026-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06480825 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Gingivitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06480825 currently recruiting?
Yes, NCT06480825 is actively recruiting participants. Contact the research team at rossana.izzetti@unipi.it for enrollment information.
Where is the NCT06480825 trial being conducted?
This trial is being conducted at Pisa, Italy, Pisa, Italy.
Who is sponsoring the NCT06480825 clinical trial?
NCT06480825 is sponsored by University of Pisa. The trial plans to enroll 40 participants.