Evidence of Spreading Vasodilation in Human Gingiva

• Sponsor: Semmelweis University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03605095
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Actual Duration (Months): 1.5
• Patients Per Site Per Month: 25.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Nitric Oxide; Vasodilation; Oral Soft Tissue Conditions	Drug: nitroglycerin	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Basic Science
• Official Title: Non-invasive Imaging of Human Gingival Microcirculation: Effect of Nitric Oxide
• Actual Study Start Date: Jul 25, 2018
• Actual Primary Completion Date: Aug 30, 2018
• Actual Study Completion Date: Sep 10, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 8 mg/ml nitroglycerin Higher concentration of NO donor (Nitromint) vs dilution	Drug: nitroglycerin; Vasodilatator solution is dropped on the gingiva.
Active Comparator: 1 mg/ml nitroglycerin Lower concentration of NO donor (Nitropohl) vs physiological saline	Drug: nitroglycerin; Vasodilatator solution is dropped on the gingiva.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Janos Vag	Budapest		Hungary	1088

Sponsors and Collaborators

• Semmelweis University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. Vag Janos, Principal Investigator, Semmelweis University
• ClinicalTrials.gov Identifier: NCT03605095
• Other Study ID Numbers: 5/2018
• First Posted: Jul 30, 2018
• Last Update Posted: Sep 11, 2018
• Last Verified: Sep 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Dr. Vag Janos, Principal Investigator, Semmelweis University: spreading vasodilation; gingival microcirculation
• Additional relevant MeSH terms: Nitroglycerin

Study Results

No Results Posted as of Sep 11, 2018