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Evidence of Spreading Vasoconstriction in Human Gingiva

Sponsor
Semmelweis University (Other)
Overall Status
Completed
CT.gov ID
NCT04131283
Collaborator
(none)
29
Enrollment
1
Location
2
Arms
8
Actual Duration (Months)
3.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
29 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Basic Science
Official Title:
Evidence of Spreading Vasoconstriction in Human Gingiva
Actual Study Start Date :
May 1, 2019
Actual Primary Completion Date :
Dec 1, 2019
Actual Study Completion Date :
Jan 1, 2020

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    Other Outcome Measures

    1. Correlation between the change in blood flow and gingival thickness [5 minutes]

      The biotpye will be assessed by measurement of gingival thickness by an ultrasonic devices. The correlation between thickness and maximal vasodilation will be evaluated.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Janos Vag Budapest Hungary 1088

    Sponsors and Collaborators

    • Semmelweis University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Vag Janos, Principal Investigator, Semmelweis University
    ClinicalTrials.gov Identifier:
    NCT04131283
    Other Study ID Numbers:
    • 1/2019
    First Posted:
    Oct 18, 2019
    Last Update Posted:
    Jul 2, 2020
    Last Verified:
    Jul 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Dr. Vag Janos, Principal Investigator, Semmelweis University
    spreading vasoconstriction
    gingival microcirculation
    Additional relevant MeSH terms:
    Disease
    Epinephrine

    Study Results

    No Results Posted as of Jul 2, 2020