Evidence of Spreading Vasoconstriction in Human Gingiva

NCT ID: NCT04131283

Last Updated: 2020-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-01
• Study Completion Date: 2020-01-01

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.

Conditions

Vasoconstriction; Oral Soft Tissue Conditions; Dental and Gingival Conditions

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Epinephrine effect throught keratinized ginigva

1 mg/ml epniephrine vs physiologocal saline

Group Type: EXPERIMENTAL

Epinephrine

Intervention Type: DRUG

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

Epinephrine effect throught gingival sulcular epithelium

1 mg/ml epniephrine vs physiologocal saline

Group Type: EXPERIMENTAL

Epinephrine

Intervention Type: DRUG

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

Interventions

Epinephrine

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

Intervention Type: DRUG

Other Intervention Names

retrograde vasoconstriction

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Semmelweis University

OTHER

Sponsor Role: lead

Responsible Party

Dr. Vag Janos

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Janos Vag

Budapest, , Hungary

Countries

Hungary

References

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.

Reference Type: DERIVED

PMID: 33148235 (View on PubMed)

Other Identifiers

1/2019

Identifier Type: -

Identifier Source: org_study_id