An observational study in Gingivitis and Periodontitis, sponsored by University of Pisa. Recruiting at 2 sites in Italy. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-01.
Sponsored by University of Pisa · Observational
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.
631 studies on the registry are indexed under Gingivitis; 107 are open to participants now.
This study's planned enrollment of 40 is below the median of 93 across 116 observational studies indexed under Gingivitis.
Browse Gingivitis studies →University of Pisa is the lead sponsor of 113 studies on the registry; 28 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
patients affected by gingivitis
Other: Performance of ultrasonographic scan
Periodontally healthy patients
Other: Performance of ultrasonographic scan
Ultra-high frequency ultrasonographic scan of gingival tissues
Echogenicity
Variations in echogenicity assessed through grey levels distribution between healthy patients versus gingivitis
Time frame: measured once at enrollemnt
Vascular parameters
Variations in vascularization assessed through grey levels distribution between healthy patients versus gingivitis
Time frame: 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.
Time frame: 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.
Time frame: measured once at enrollement
FMBS
Full Mouth Bleeding Score (FMBS) will be determined dichotomously post-probing.
Time frame: 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.
Time frame: measured once at enrollement
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