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

NCT06480825 · tracked via the Priya Life Science Italy tracker

Sponsor

University of Pisa

Phase

Observational

Started

2024-04-02

Last updated

2026-04-01

Condition(s) studied

GingivitisPeriodontitis

Investigational drug(s) / intervention(s)

Performance of ultrasonographic scan

Performance of ultrasonographic scan: Ultra-high frequency ultrasonographic scan of gingival tissues

Study 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

Sex

ALL

Min age

18 Years

Max age

70 Years

Healthy volunteers

Accepted

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

Primary outcome measure(s)

Echogenicity — measured once at enrollemnt
Variations in echogenicity assessed through grey levels distribution between healthy patients versus gingivitis

Trial sites (2)

Facility	City	Region	Status
University of Pisa	Pisa	Italy	Recruiting
Department of Surgical, Medical and Molecular Pathology and Critical Care Medicine, University Hospital of Pisa	Pisa	Italy	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06480825 on ClinicalTrials.gov ↗ ← All trials in Italy