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Evidence of Spreading Vasodilation in Human Gingiva

Non-invasive Imaging of Human Gingival Microcirculation: Effect of Nitric Oxide

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03605095
Enrollment
40
Registered
2018-07-30
Start date
2018-07-25
Completion date
2018-09-10
Last updated
2018-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nitric Oxide, Oral Soft Tissue Conditions, Vasodilation

Keywords

spreading vasodilation, gingival microcirculation

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.

Interventions

DRUGnitroglycerin

Vasodilatator solution is dropped on the gingiva.

Sponsors

Semmelweis University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
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) * smoking * periodontitis * caries * insufficient marginal integrity

Design outcomes

Primary

MeasureTime frameDescription
Blood flow change after application of NO agonist30 minThe change in blood flow will be measured after locally applied nitroglycerin at the site fo application and at the remote sites

Secondary

MeasureTime frameDescription
Comparsion of the change in blood flow between genders30minThe maximal blood flow changed assessed in primary outcome will be split into two groups based on gender. The change will be compared between males and females.
Correlation between the change in blood flow and gingival thickness30minThe biotpye will be assessed by measurement of gingival thickness by an ultrasonic devices. The correlation between thickness and maximal vasodilation will be evaluated.

Countries

Hungary

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026