Evidence of Spreading Vasodilation in Human Gingiva

Vasodilation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03605095
• Other study ID #: 5/2018
• Status: Completed
• Phase: N/A
• Start date: July 25, 2018
• Est. completion date: September 10, 2018

Study information

• Verified date: September 2018
• Source: Semmelweis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 10, 2018
• Est. primary completion date: August 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Nitric Oxide
• Oral Soft Tissue Conditions
• Vasodilation

Intervention

Drug:
• nitroglycerin
Vasodilatator solution is dropped on the gingiva.

Locations

Country	Name	City	State
Hungary	Janos Vag	Budapest

Sponsors (1)

Lead Sponsor	Collaborator
Semmelweis University

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood flow change after application of NO agonist	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	Comparsion of the change in blood flow between genders	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
Secondary	Correlation between the change in blood flow and gingival thickness	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