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Evidence of Spreading Vasoconstriction in Human Gingiva

Evidence of Spreading Vasoconstriction in Human Gingiva

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04131283
Enrollment
29
Registered
2019-10-18
Start date
2019-05-01
Completion date
2020-01-01
Last updated
2020-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental and Gingival Conditions, Oral Soft Tissue Conditions, Vasoconstriction

Keywords

spreading vasoconstriction, gingival microcirculation

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.

Interventions

DRUGEpinephrine

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

Sponsors

Semmelweis University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Blood flow change after application of epinephrine30 minutesThe change in blood flow will be measured after locally applied epinephrine at the site fo application and at the remote sites

Secondary

MeasureTime frameDescription
Comparsion of the change in blood flow between genders30 minutesThe 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

MeasureTime frameDescription
Correlation between the change in blood flow and gingival thickness5 minutesThe biotpye will be assessed by measurement of gingival thickness by an ultrasonic devices. The correlation between thickness and maximal vasodilation will be evaluated.

Countries

Hungary

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026