Evidence of Spreading Vasoconstriction in Human Gingiva

Not Applicable

Completed

• Conditions: Dental and Gingival Conditions; Oral Soft Tissue Conditions; Vasoconstriction
• Interventions: Drug: Epinephrine

• Registration Number: NCT04131283
• Lead Sponsor: Semmelweis University

Brief 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.

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 Timeline

• Study Start: 2019-05-01
• Study First Submitted: 2019-10-16
• Study First Submitted QC: 2019-10-16
• Study First Posted: 2019-10-18
• Primary Completion: 2019-12-01
• Study Completion: 2020-01-01
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-01
• Last Update Posted: 2020-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Epinephrine effect throught keratinized ginigva	Epinephrine	1 mg/ml epniephrine vs physiologocal saline
Epinephrine effect throught gingival sulcular epithelium	Epinephrine	1 mg/ml epniephrine vs physiologocal saline

Primary Outcome Measures

Name	Time	Method
Blood flow change after application of epinephrine	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 Outcome Measures

Name	Time	Method
Comparsion of the change in blood flow between genders	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.

Trial Locations

Locations (1)

Janos Vag; 🇭🇺 Budapest, Hungary