Non-invasive Imaging of Human Gingival Microcirculation: Effect of Nitric Oxide
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Semmelweis University
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Blood flow change after application of NO agonist
Study Overview
Brief Summary
The aim of this study is to observe the mechanism of spreading vasodilatation on human healthy gingiva. Nitric-oxide donor solutions in lower and higher concentration are used to trigger the vasoactivity.
Detailed Description
Spatial regulation of gingival microcirculation has not been revealed yet. Although this could be an important mechanism to protect gingiva as it is exposed to mechanical, chemical, thermal etc. irritation during whole life. It is especially important during flap surgery. Laser Speckle Contrast Imaging (LSCI) is novel non-invasive method with high spatio-temporal resolution, therefore it allows us to study remote effect of local vasodilation such as spreading vasodilation in human gingiva.
The vasodilatator nitric-oxide (NO) donor will be used to trigger remote effect on gingiva. NO donor solutions will be applied in 1 mg/ml and 8 mg/ml nitroglycerin concentrations. Solution will be dropped on the gingiva at tooth 12 in a fabricated leakage proof well attached to 2mm above the marginal gingiva. The change on blood flow will be monitor at the test well with surrounding gingival area spanning 3 tooth and at the contralateral side by LSCI.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •general health
- •minimum 5 mm keratinized gingiva at upper front teeth
Exclusion Criteria
- •pregnancy and breast-feeding
- •medication (except contraceptives)
- •periodontitis
- •insufficient marginal integrity
Arms & Interventions
8 mg/ml nitroglycerin
Higher concentration of NO donor (Nitromint) vs dilution
Intervention: nitroglycerin (Drug)
1 mg/ml nitroglycerin
Lower concentration of NO donor (Nitropohl) vs physiological saline
Intervention: nitroglycerin (Drug)
Outcomes
Primary Outcomes
Blood flow change after application of NO agonist
Time Frame: 30 min
The change in blood flow will be measured after locally applied nitroglycerin at the site fo application and at the remote sites
Secondary Outcomes
- Comparsion of the change in blood flow between genders(30min)
- Correlation between the change in blood flow and gingival thickness(30min)
Investigators
Dr. Vag Janos
Principal Investigator
Semmelweis University