Evidence of Spreading Vasodilation in Human Gingiva

Semmelweis University

Status: Completed

Conditions: Oral Soft Tissue Conditions; Vasodilation; Nitric Oxide

Treatments: Drug: nitroglycerin

Study type: Interventional

Funder types: Other

Identifiers

NCT03605095

5/2018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

8 mg/ml nitroglycerin

Active Comparator group

Description:

Higher concentration of NO donor (Nitromint) vs dilution

Treatment:

Drug: nitroglycerin

1 mg/ml nitroglycerin

Active Comparator group

Description:

Lower concentration of NO donor (Nitropohl) vs physiological saline

Treatment:

Drug: nitroglycerin