Investigation of Endothelium-dependent Vasodilation in Human Gingiva Depending on Serum Estrogen Level
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Semmelweis University
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- 1. Blood flow change after applying the test solution
Study Overview
Brief Summary
The first aim of this study is to create a cumulative dose-response curve for acetylcholine in men (low serum estrogen levels) to determine the lowest concentration with which we can induce a maximal vasodilation effect on the human gingiva. Furthermore, the second aim of this study is the characterization of the age-dependent effect of sex hormones on gingival blood flow, as well as of the gender differences by applying this concentration to premenopausal men and women with low and high estrogen levels, as well as to postmenopausal subjects.
Detailed Description
Gender differences were observed in studies according to gingival microcirculation between physiological circumstances and during wound healing as well.
For blood flow measurement, Laser Speckle Contrast Imaging is a reliable tool. It has good reproducibility, does not touch the measured surface, is easy to use, and can simultaneously measure on a bigger surface.
Two wells are fabricated on the surface of the right lateral incisor (test site) and the labial surface of the left central incisor (control site). These wells are opened towards the high-permeability gingival sulcus, so the dropped solutions acetylcholine vs. physiological saline can easily penetrate the gingival tissues. After applying the solutions, the blood flow is monitored for 19 minutes.
In the study's second phase, blood sampling is taken before the gingival blood flow measurement.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •healthy systemic and periodontal conditions
Exclusion Criteria
- •systemic disease and medication
- •periodontal disease
Arms & Interventions
Acetylcholine 0,1 mg/mL and 1 mg/mL and 10 mg/mL
Vasodilator solution is dropped on the labial surface of the lateral incisor, which penetrates into the gingival sulcus.
In the dose-response study, 0,1 mg/mL, 1 mg/mL, and 10 mg/mL acetylcholine solution is dropped into the gingival sulcus, and every solution remains there for 2:30 minutes between them is always a 30-second long pause.
In the second phase of the study, where the sex differences are monitored, 10 mg/mL acetylcholine solution is dropped into the gingival sulcus for 15 minutes
Intervention: Acetylcholine Chloride (Drug)
Outcomes
Primary Outcomes
1. Blood flow change after applying the test solution
Time Frame: 19 minutes
The change in blood flow will be measured after applying the test solution
Secondary Outcomes
No secondary outcomes reported
Investigators
Dr. Vag Janos
professor
Semmelweis University