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Recruiting NCT06480825

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

Observational Gingivitis Periodontitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Performance of ultrasonographic scan.
Who it may be relevant to
Registry conditions: Gingivitis, Periodontitis. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Other Performance of ultrasonographic scan
    Ultra-high frequency ultrasonographic scan of gingival tissues

Primary outcome measures

  • Echogenicity [Time frame: measured once at enrollemnt]
Secondary outcome measures (5)
  • Vascular parameters [Time frame: measured once at enrollemnt]
  • DMFT [Time frame: measured once at enrollement]
  • PPD [Time frame: measured once at enrollement]
  • FMBS [Time frame: measured once at enrollement]
  • FMPS [Time frame: measured once at enrollement]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Italy · 2 centers
  • University of Pisa — Pisa
  • Department of Surgical, Medical and Molecular Pathology and Critical Care Medicine, Univer — Pisa

Identifiers

NCT: NCT06480825 · 7935870439

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗