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.

Study Overview

• Status: Completed
• Conditions: Vasoconstriction; Oral Soft Tissue Conditions; Dental and Gingival Conditions
• Intervention / Treatment: Drug: Epinephrine

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 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.

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hungary
  • Budapest, Hungary, 1088
    • Janos Vag

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Epinephrine effect throught keratinized ginigva; 1 mg/ml epniephrine vs physiologocal saline	Drug: Epinephrine; Vasoconstrictor solution is applied on the surface of the attached gingiva and on the gingival sulcus.; Other Names: retrograde vasoconstriction
EXPERIMENTAL: Epinephrine effect throught gingival sulcular epithelium; 1 mg/ml epniephrine vs physiologocal saline	Drug: Epinephrine; Vasoconstrictor solution is applied on the surface of the attached gingiva and on the gingival sulcus.; Other Names: retrograde vasoconstriction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Semmelweis University

Publications and helpful links

General Publications

• Vag J, Ganti B, Mikecs B, Szabo E, Molnar B, Lohinai Z. Epinephrine penetrates through gingival sulcus unlike keratinized gingiva and evokes remote vasoconstriction in human. BMC Oral Health. 2020 Nov 4;20(1):305. doi: 10.1186/s12903-020-01296-z.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2019
• Primary Completion (ACTUAL): December 1, 2019
• Study Completion (ACTUAL): January 1, 2020

Study Registration Dates

• First Submitted: October 16, 2019
• First Submitted That Met QC Criteria: October 16, 2019
• First Posted (ACTUAL): October 18, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 2, 2020
• Last Update Submitted That Met QC Criteria: July 1, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: spreading vasoconstriction; gingival microcirculation
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Epinephrine
• Other Study ID Numbers: 1/2019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No