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

Recruiting

• Conditions: Gingivitis; Periodontitis
• Interventions: Other: Performance of ultrasonographic scan

• Registration Number: NCT06480825
• Lead Sponsor: University of Pisa

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-02
• Study First Submitted: 2024-06-24
• Study First Submitted QC: 2024-06-24
• Study First Posted: 2024-06-28
• Status Verified: 2024-12
• Primary Completion: 2024-12
• Study Completion: 2024-12
• Last Update Submitted: 2024-12-18
• Last Update Posted: 2024-12-19

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control group	Performance of ultrasonographic scan	Periodontally healthy patients
Gingivitis group	Performance of ultrasonographic scan	patients affected by gingivitis

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Vascular parameters	measured once at enrollemnt	Variations in vascularization assessed through grey levels distribution between healthy patients versus gingivitis
DMFT	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.
PPD	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.
FMBS	measured once at enrollement	Full Mouth Bleeding Score (FMBS) will be determined dichotomously post-probing.
FMPS	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.

Trial Locations

Locations (2)

University of Pisa; 🇮🇹 Pisa, Italy

Department of Surgical, Medical and Molecular Pathology and Critical Care Medicine, University Hospital of Pisa; 🇮🇹 Pisa, Italy