Skip to main content
OpenTrials
Completed

NCT Number: NCT04131283

Evidence of Spreading Vasoconstriction in Human Gingiva

The aim of this study is to observe the mechanism of spreading vasoconstriction in human healthy gingiva. Epinephrine solution is applied on the attached gingiva in group "A" and on the surface of the tooth next to the ginvial sulcus in group "B". The different placement of the solution causes different effect in the microcirculation.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Vasoconstriction Dental and Gingival Conditions Oral Soft Tissue Conditions

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 vasoconstriction such as spreading vasoconstriction in human gingiva.

The epinephrine is a daily used vasoconstrictor material in dentistry and it will be used to trigger remote effect on gingiva. Epinephrine in 1 mg/ml concentration. Solution will be dropped on the gingiva at tooth 12 in a fabricated leakage proof well attached to 2mm above the marginal gingiva in group "A". The solution will be dropped on the surface of tooth 12 next to the sulcus into the well in case of group "B". The changes of the blood flow will be monitor at the test side with surrounding gingival area by LSCI. The control side in each case will be - appropriately to the test side - at tooth 21 with phisiologocal saline.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • at least 5 mm keratinized gingiva at the upper front teeth
  • general health

Exclusion criteria

  • pregnancy, breast-feeding
  • any medication
  • smoking, gingivitis, caries and coronal restoration with insufficient marginal integrity

Treatment and study plan

Epinephrine

Drug

Vasoconstrictor solution is applied on the surface of the attached gingiva and on the gingival sulcus.

Other names: retrograde vasoconstriction

Primary outcomes

  1. Blood flow change after application of epinephrine

    Time frame: 30 minutes

    The change in blood flow will be measured after locally applied epinephrine at the site fo application and at the remote sites

Secondary outcomes

  1. Comparsion of the change in blood flow between genders

    Time frame: 30 minutes

    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.

Other outcomes

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

    Time frame: 5 minutes

    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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Oct 18, 2019
Registry last updated
Jul 2, 2020

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.