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

NCT06480825 | Recruiting

• 1 other identifier: 7935870439
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Periodontitis; Gingivitis

Outcome Measures

Primary Outcomes (1)

• Echogenicity

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

  measured once at enrollemnt

Secondary Outcomes (5)

• Vascular parameters

  measured once at enrollemnt

• DMFT

  measured once at enrollement

• PPD

  measured once at enrollement

• FMBS

  measured once at enrollement

• FMPS

  measured once at enrollement

Study Arms (2)

Gingivitis group

patients affected by gingivitis

Other: Performance of ultrasonographic scan

Control group

Periodontally healthy patients

Other: Performance of ultrasonographic scan

Interventions

Performance of ultrasonographic scan OTHER

Ultra-high frequency ultrasonographic scan of gingival tissues

Control group; Gingivitis group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pisa: lead

Study Sites (2)

University of Pisa

Pisa, Italy, 56126, Italy

RECRUITING

Department of Surgical, Medical and Molecular Pathology and Critical Care Medicine, University Hospital of Pisa

Pisa, Italy

RECRUITING

MeSH Terms

Conditions

Gingivitis; Periodontitis

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Rossana Izzetti

CONTACT

3475205619; rossana.izzetti@unipi.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Researcher at the Department of Surgical, Medical and Molecular Pathology and Critical Care Medicine of the University of Pisa

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: June 28, 2024
• Study Start: April 2, 2024
• Primary Completion: January 31, 2026
• Study Completion (Estimated): July 1, 2028
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

IT (2)