Evidence of Spreading Vasodilation in Human Gingiva

NCT ID: NCT03605095

Last Updated: 2018-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-25

Study Completion Date

2018-09-10

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Nitric Oxide Vasodilation Oral Soft Tissue Conditions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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8 mg/ml nitroglycerin

Higher concentration of NO donor (Nitromint) vs dilution

Group Type ACTIVE_COMPARATOR

nitroglycerin

Intervention Type DRUG

Vasodilatator solution is dropped on the gingiva.

1 mg/ml nitroglycerin

Lower concentration of NO donor (Nitropohl) vs physiological saline

Group Type ACTIVE_COMPARATOR

nitroglycerin

Intervention Type DRUG

Vasodilatator solution is dropped on the gingiva.

Interventions

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nitroglycerin

Vasodilatator solution is dropped on the gingiva.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Semmelweis University

OTHER

Sponsor Role lead

Responsible Party

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Dr. Vag Janos

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Janos Vag

Budapest, , Hungary

Site Status

Countries

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Hungary

Other Identifiers

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5/2018

Identifier Type: -

Identifier Source: org_study_id

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