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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Periodontitis; Gingivitis
• Intervention / Treatment: Other: Performance of ultrasonographic scan

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Rossana Izzetti; Phone Number: 3475205619; Email: rossana.izzetti@unipi.it

Study Locations

• Italy
  • Pisa, Italy
    • Recruiting
    • Department of Surgical, Medical and Molecular Pathology and Critical Care Medicine, University Hospital of Pisa
    • Contact: Rossana Izzetti; Phone Number: 3475205619; Email: rossana.izzetti@unipi.it
  • Italy
    • Pisa, Italy, Italy, 56126
      • Recruiting
      • University of Pisa
      • Contact: Rossana Izzetti; Phone Number: +39050993037; Email: rossana.izzetti@unipi.it
      • Principal Investigator: Rossana Izzetti

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients referred to the Sub-Unit of Periodontology, Halitosis, and Periodontal Medicine of the Unit of Dentistry and Oral Surgery at the University Hospital of Pisa will be enrolled.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Gingivitis group; patients affected by gingivitis	Other: Performance of ultrasonographic scan; Ultra-high frequency ultrasonographic scan of gingival tissues
Control group; Periodontally healthy patients	Other: Performance of ultrasonographic scan; Ultra-high frequency ultrasonographic scan of gingival tissues

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Echogenicity	Variations in echogenicity assessed through grey levels distribution between healthy patients versus gingivitis	measured once at enrollemnt

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vascular parameters	Variations in vascularization assessed through grey levels distribution between healthy patients versus gingivitis	measured once at enrollemnt
DMFT	The Decayed-Missing-Filled Teeth (DMFT) index, categorized as Low (0-4), Moderate (5-13), and High (14+), will evaluate overall dental health.	measured once at enrollement
PPD	Probing Pocket Depth (PPD) will be measured using a UNC-15 periodontal probe with 0.3 N pressure, recording six sites per tooth (distobuccal, buccal, mesiobuccal, distolingual, lingual, mesiolingual), rounded to the nearest millimeter.	measured once at enrollement
FMBS	Full Mouth Bleeding Score (FMBS) will be determined dichotomously post-probing.	measured once at enrollement
FMPS	Full Mouth Plaque Score (FMPS) will assess plaque presence on each tooth surface, with scores of 1 for presence and 0 for absence across six sites per tooth.	measured once at enrollement

Collaborators and Investigators

• Sponsor: University of Pisa

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2024
• Primary Completion (Actual): January 31, 2026
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: June 24, 2024
• First Submitted That Met QC Criteria: June 24, 2024
• First Posted (Actual): June 28, 2024

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases; Periodontitis; Gingivitis
• Other Study ID Numbers: 7935870439

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No