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NCT Number: NCT06480825

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

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Key information

Conditions

Gingivitis Gingival Diseases Infections Mouth Diseases Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Pisa, Pisa, Italy

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Performance of ultrasonographic scan

Other

Ultra-high frequency ultrasonographic scan of gingival tissues

Primary outcomes

  1. Echogenicity

    Time frame: measured once at enrollemnt

    Variations in echogenicity assessed through grey levels distribution between healthy patients versus gingivitis

Secondary outcomes

  1. Vascular parameters

    Time frame: measured once at enrollemnt

    Variations in vascularization assessed through grey levels distribution between healthy patients versus gingivitis

  2. DMFT

    Time frame: measured once at enrollement

    The Decayed-Missing-Filled Teeth (DMFT) index, categorized as Low (0-4), Moderate (5-13), and High (14+), will evaluate overall dental health.

  3. PPD

    Time frame: measured once at enrollement

    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.

  4. FMBS

    Time frame: measured once at enrollement

    Full Mouth Bleeding Score (FMBS) will be determined dichotomously post-probing.

  5. FMPS

    Time frame: measured once at enrollement

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Rossana Izzetti

CONTACT

[email protected]

3475205619

Sponsors and collaborators

Lead sponsor

University of Pisa

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Jun 28, 2024
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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