Evidence of Spreading Vasodilation in Human Gingiva

Not Applicable

Completed

• Conditions: Nitric Oxide; Vasodilation; Oral Soft Tissue Conditions
• Interventions: Drug: nitroglycerin

• Registration Number: NCT03605095
• Lead Sponsor: Semmelweis University

Brief 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.

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 Timeline

• Study First Submitted: 2018-07-11
• Study First Submitted QC: 2018-07-20
• Study Start: 2018-07-25
• Study First Posted: 2018-07-30
• Primary Completion: 2018-08-30
• Status Verified: 2018-09
• Study Completion: 2018-09-10
• Last Update Submitted: 2018-09-10
• Last Update Posted: 2018-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
8 mg/ml nitroglycerin	nitroglycerin	Higher concentration of NO donor (Nitromint) vs dilution
1 mg/ml nitroglycerin	nitroglycerin	Lower concentration of NO donor (Nitropohl) vs physiological saline

Primary Outcome Measures

Name	Time	Method
Blood flow change after application of NO agonist	30 min	The change in blood flow will be measured after locally applied nitroglycerin at the site fo application and at the remote sites

Secondary Outcome Measures

Name	Time	Method
Comparsion of the change in blood flow between genders	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.
Correlation between the change in blood flow and gingival thickness	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.

Trial Locations

Locations (1)

Janos Vag; 🇭🇺 Budapest, Hungary