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Completed

NCT Number: NCT03605095

Evidence of Spreading Vasodilation in Human Gingiva

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.

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Key information

Conditions

Nitric Oxide Aneurysm Cardiovascular Diseases Oral Soft Tissue Conditions Vascular Diseases Vasodilation

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Janos Vag

Budapest, 1088, Hungary

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nitroglycerin

Drug

Vasodilatator solution is dropped on the gingiva.

Primary outcomes

  1. 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

  1. Comparsion of the change in blood flow between genders

    Time frame: 30min

    The 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.

  2. Correlation between the change in blood flow and gingival thickness

    Time frame: 30min

    The biotpye will be assessed by measurement of gingival thickness by an ultrasonic devices. The correlation between thickness and maximal vasodilation will be evaluated.

Sponsors and collaborators

Lead sponsor

Semmelweis University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 30, 2018
Registry last updated
Sep 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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