Evidence of Spreading Vasoconstriction in Human Gingiva

Vasoconstriction Clinical Trial

Official title:

Evidence of Spreading Vasoconstriction in Human Gingiva

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04131283
• Other study ID #: 1/2019
• Status: Completed
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: January 1, 2020

Study information

• Verified date: July 2020
• Source: Semmelweis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: January 1, 2020
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental and Gingival Conditions
• Disease
• Oral Soft Tissue Conditions
• Vasoconstriction

Intervention

Drug:
• Epinephrine
Vasoconstrictor solution is applied on the surface of the attached gingiva and on the gingival sulcus.

Locations

Country	Name	City	State
Hungary	Janos Vag	Budapest

Sponsors (1)

Lead Sponsor	Collaborator
Semmelweis University

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Correlation between the change in blood flow and gingival thickness	The biotpye will be assessed by measurement of gingival thickness by an ultrasonic devices. The correlation between thickness and maximal vasodilation will be evaluated.	5 minutes
Primary	Blood flow change after application of epinephrine	The change in blood flow will be measured after locally applied epinephrine at the site fo application and at the remote sites	30 minutes
Secondary	Comparsion of the change in blood flow between genders	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.	30 minutes