Endothelium Dependent and Non-dependent Vasodilatation in Human Gingiva

June 9, 2021 updated by: Dr. Vag Janos, Semmelweis University

Investigation of the Endothel Dependent and Independent Vasodilatation in Human Gingiva: Comparison of the Effect of NO and ACH

The aim of this study is to compare the endothelim-dependent and non-dependent vasodilatation between genders in the human gingiva.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Gender differences were observed in studies according to gingival microcirculation between physiological circumstances and during wound healing as well.

For blood flow measurement Laser Spackle Contrast Imaging is a reliable tool. It has good reproducibility, it doesn't get in touch with the measured surface, it's easy to use and it can measure on a bigger surface in same time.

Two wells were fabricated on the labial surface of the right lateral incisor (test tooth) and on the labial surface of the left central incisor (control tooth). These wells are opened towards the high-prermeability gingival sulcus, so the dropped solutions nitroglycerine vs physiological saline or nitroglycerine vs physiological saline can esasily penetrate to the gingival tissues. After applying the solutions, the blood flow was monitored fot 15 minutes.

Study Type

Interventional

Enrollment (Actual)

24

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
        • Semmelweis University, Department of Conservative Dentistry

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

20 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • general health
  • minimum 5 mm keratinized gingiva at the upper front teeth
  • good oral hygiene

Exclusion Criteria:

  • pregnancy and breast-feeding
  • smoking
  • medication
  • insufficient marginal integrity
  • periodontitis
  • caries

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: nitroglycerin

NO donor (Nitropohl) vs pgysiological saline

1mg/ml nitorhlycerin
Drug: Nitroglycerin
Vasodilatator solution is dropped on the labial surface on the lateral incisor, so it can penetrate through the sulcus.
Active Comparator: acethylcholine
10 mg/ml acetylcholine vs physiological saline
Drug: Acetylcholine
Vasodilatator solution is dropped on the labial surface on the lateral incisor, so it can penetrate through the sulcus.
Other Names:
  • Ach

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood flow change after applying the test solutions
Time Frame: 20 minutes
The change in blood flow will be measeured after applying the test solutions.
20 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison the change in blood flow between the two solutions
Time Frame: 30 minutes
The blood flow values will be evaluated after each applied solutions.
30 minutes
Comparison the change in blood flow in genders
Time Frame: 20 minutes
The maximal blood flow changes assessed in primary outcome will be split into two groups based on gender. The change will be compared between males and females.
20 minutes

Collaborators and Investigators

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

Sponsor

Semmelweis University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

September 15, 2020

Primary Completion (Actual)

April 15, 2021

Study Completion (Actual)

May 15, 2021

Study Registration Dates

First Submitted

June 2, 2021

First Submitted That Met QC Criteria

June 2, 2021

First Posted (Actual)

June 9, 2021

Study Record Updates

Last Update Posted (Actual)

June 14, 2021

Last Update Submitted That Met QC Criteria

June 9, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1/2020

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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