Evidence of Spreading Vasodilation in Human Gingiva

September 10, 2018 updated by: Dr. Vag Janos, Semmelweis University

Non-invasive Imaging of Human Gingival Microcirculation: Effect of Nitric Oxide

The aim of this study is to observe the mechanism of spreading vasodilatation on human healthy gingiva. Nitric-oxide donor solutions in lower and higher concentration are used to trigger the vasoactivity.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 vasodilation such as spreading vasodilation in human gingiva.

The vasodilatator nitric-oxide (NO) donor will be used to trigger remote effect on gingiva. NO donor solutions will be applied in 1 mg/ml and 8 mg/ml nitroglycerin concentrations. Solution will be dropped on the gingiva at tooth 12 in a fabricated leakage proof well attached to 2mm above the marginal gingiva. The change on blood flow will be monitor at the test well with surrounding gingival area spanning 3 tooth and at the contralateral side by LSCI.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Budapest, Hungary, 1088
        • Janos Vag

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • general health
  • minimum 5 mm keratinized gingiva at upper front teeth

Exclusion Criteria:

  • pregnancy and breast-feeding
  • medication (except contraceptives)
  • smoking
  • periodontitis
  • caries
  • insufficient marginal integrity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 8 mg/ml nitroglycerin
Higher concentration of NO donor (Nitromint) vs dilution
Drug: nitroglycerin
Vasodilatator solution is dropped on the gingiva.
Active Comparator: 1 mg/ml nitroglycerin
Lower concentration of NO donor (Nitropohl) vs physiological saline
Drug: nitroglycerin
Vasodilatator solution is dropped on the gingiva.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood flow change after application of NO agonist
Time Frame: 30 min
The change in blood flow will be measured after locally applied nitroglycerin at the site fo application and at the remote sites
30 min

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparsion of the change in blood flow between genders
Time Frame: 30min
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.
30min
Correlation between the change in blood flow and gingival thickness
Time Frame: 30min
The biotpye will be assessed by measurement of gingival thickness by an ultrasonic devices. The correlation between thickness and maximal vasodilation will be evaluated.
30min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Semmelweis University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 25, 2018

Primary Completion (Actual)

August 30, 2018

Study Completion (Actual)

September 10, 2018

Study Registration Dates

First Submitted

July 11, 2018

First Submitted That Met QC Criteria

July 20, 2018

First Posted (Actual)

July 30, 2018

Study Record Updates

Last Update Posted (Actual)

September 11, 2018

Last Update Submitted That Met QC Criteria

September 10, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5/2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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