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"Ultra-High Frequency intraOral UltraSonography of the TONgue" (HOUSTON)
Study Purpose
Oral diseases are currently diagnosed by means of clinical examination and supported by surgical biopsy procedures. In particular, daily oral medicine practice is lacking the use of a routine diagnostic support to the visualization of anatomical structures located beyond the mucosal surface. Considering the growing interest in minimally invasive diagnosis, the possibility of having an imaging technique dedicated to the investigation of oral soft tissues and their alterations may be instrumental to support the clinical diagnosis. Therefore, attempts to introduce conventional ultrasonography (US) to the diagnostic work-up of pathological conditions of the head and neck have been done, exploiting the unique features of this technique in terms of limited invasive- ness, repeatability, and cost efficiency. In the literature, both extraoral and intraoral applications of US have been reported. Extraoral applications mainly focus on the characterization of oral and maxillofacial swellings of various origin, while intraoral applications mostly involve the study of malignant lesions in terms of tumor thickness and depth of invasion. The aim of the present protocol is to evaluate the role of intraoral ultra-high frequency ultrasonography in the study of oral mucosal lesions.
Recruitment Criteria
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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Inclusion Criteria:
Exclusion Criteria:
- - Uncontrolled chronic diseases and/or conditions hindering the participation in the
study.
- Denial of inclusion in the studyTrial Details
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
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Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
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The disease, disorder, syndrome, illness, or injury that is being studied.
Arms
Experimental: Ultrasound group
The patients with a clinical diagnosis of oral squamous cell carcinoma will undergo intraoral ultrasonographic scan with a 70 MHz frequency probe to evaluate tumor depth of invasion and thickness
Interventions
Device: - Ultrasound
Ultrasonographic scan with a 70 MHz probe
Contact a Trial Team
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International Sites
Status
Recruiting
Address
Università di Pisa
Pisa, , 56126
Site Contact
Rossana Izzetti, DS, PhD
[email protected]
+39050993037
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