Oral mucosal microcirculation measurements in healthy volunteers

Recruiting

• Conditions: variation in healthy tissue; Healthy tissue

• Registration Number: NL-OMON43270
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 600

Inclusion Criteria

- ASA 1 and 2 volunteers (smokers, social alcohol drinker, pregnancy, 30- Volunteers that signed an informed consent form
- Volunteers >18 years

Exclusion Criteria

- Past history of head and neck malignancy or other relevant pathologies
- Volunteers with known medical history of renal failure, blood dyscrasia or chronic liver disease
of any type, uncontrolled diabetes mellitus and/or hypertension, and HIV infection
- Volunteers on anticoagulants or corticosteroids prior (<15 days) to entry into this study
- Previous history of radiation therapy to the head and neck
- Organ or marrow transplant candidates or recipients
- Volunteers that did not sign an informed consent form
- Volunteers <18 years

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Observations:<br /><br>Conventional microcirculation data parameters such as total vessel density<br /><br>(TVD), total capillary density (TCD), perfused vessel density (PVD), functional<br /><br>capillary density (FCD), the proportion of perfused vessels (PPV), proportion<br /><br>of perfused capillaries (PPC), microvascular flow index (MFI), heterogeneity<br /><br>index (HI), and blood vessel diameters (BVd) will be analyzed in all digital<br /><br>video image data samples. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Not applicable.</p><br>