Application of Ultra-high Frequency Ultrasonography (UHFUS) to the Study of Gingival Tissues
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorUniversity of Pisa
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
males or females of age > 18 years
presence of at least 20 teeth
full-mouth plaque score (FMPS) >50%
FMBS >30%
Disqualifiers
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
Trial 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.
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Performance of ultrasonographic scan
Other interventionUltra-high frequency ultrasonographic scan of gingival tissues
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Gingivitis group1 intervention
Group B: Control group1 intervention
Trial outcomes
Primary outcomes
1
Echogenicity
Variations in echogenicity assessed through grey levels distribution between healthy patients versus gingivitis
Time frame
measured once at enrollemntSecondary outcomes
1
Vascular parameters
Variations in vascularization assessed through grey levels distribution between healthy patients versus gingivitis
Time frame
measured once at enrollemnt2
DMFT
The Decayed-Missing-Filled Teeth (DMFT) index, categorized as Low (0-4), Moderate (5-13), and High (14+), will evaluate overall dental health.
Time frame
measured once at enrollement3
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.
Time frame
measured once at enrollement4
FMBS
Full Mouth Bleeding Score (FMBS) will be determined dichotomously post-probing.
Time frame
measured once at enrollementSponsors and contacts
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Source ClinicalTrials.gov