GingivitisNCT06480825
Application of Ultra-high Frequency Ultrasonography (UHFUS) to the Study of Gingival Tissues
An observational study of Gingivitis and Periodontitis, run by University of Pisa at 2 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis, Periodontitis
- What is being tested?
- Performance of ultrasonographic scan
- How many people
- 40 participants
- Where
- 2 sitesItaly
- Study dates
- 2 Apr 2024to Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Recruiting
University of Pisa
Pisa, Italy, 56126
Rossana Izzetti, +39050993037, rossana.izzetti@unipi.it
Rossana Izzetti
- Recruiting
Department of Surgical, Medical and Molecular Pathology and Critical Care Medicine, University Hospital of Pisa
Pisa
Rossana Izzetti, 3475205619, rossana.izzetti@unipi.it
About this study
Official title: Ulta-High Frequency Ultrasound Assessment of Normal Versus Gingivitis Affected 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.
- Conditions
- Gingivitis, Periodontitis
- Being tested
- Performance of ultrasonographic scan
- Medical subject headings
- Gingivitis, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Performance of ultrasonographic scanOther
Ultra-high frequency ultrasonographic scan of gingival tissues
| Study group | Role | What they receive |
|---|---|---|
| Gingivitis group | patients affected by gingivitis Receives: Other: Performance of ultrasonographic scan | |
| Control group | Periodontally healthy patients Receives: Other: Performance of ultrasonographic scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Echogenicity
Variations in echogenicity assessed through grey levels distribution between healthy patients versus gingivitis
Measured: measured once at enrollemnt
Secondary outcomes (5)
Vascular parameters
Variations in vascularization assessed through grey levels distribution between healthy patients versus gingivitis
Measured: 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.
Measured: 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.
Measured: measured once at enrollement
FMBS
Full Mouth Bleeding Score (FMBS) will be determined dichotomously post-probing.
Measured: 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.
Measured: measured once at enrollement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start2 Apr 2024
- Primary completion31 Jan 2026
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pisa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rossana Izzetti, University of Pisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06480825
- Sponsor's protocol ID
- 7935870439
- Status last verified
- Mar 2026
- First submitted
- 24 Jun 2024
- Last updated
- 1 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ulta-High Frequency Ultrasound Assessment of Normal Versus Gingivitis Affected Gingival Tissues
- ClinicalTrials.gov ID
- NCT06480825
- Acronym / sponsor ID
- 7935870439
- Conditions
- Gingivitis, Periodontitis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of PisaUniversity, hospital or other
- Study start
- 2 Apr 2024 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- Jul 2028 (estimated)
- First posted
- 28 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gingivitis group | – | Other: Performance of ultrasonographic scanpatients affected by gingivitis |
| Control group | – | Other: Performance of ultrasonographic scanPeriodontally healthy patients |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Performance of ultrasonographic scanUltra-high frequency ultrasonographic scan of gingival tissues | Other | Control group, Gingivitis group |
Primary outcome
Echogenicity
Time frame: measured once at enrollemnt
Variations in echogenicity assessed through grey levels distribution between healthy patients versus gingivitis
5 secondary outcomes
Vascular parameters
Time frame: measured once at enrollemnt
DMFT
Time frame: measured once at enrollement
PPD
Time frame: measured once at enrollement
FMBS
Time frame: measured once at enrollement
FMPS
Time frame: measured once at enrollement
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gingivitis and Periodontitis, run by University of Pisa at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rossana Izzetti (3475205619, rossana.izzetti@unipi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Echogenicity (time frame: measured once at enrollemnt). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.