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Investigation of Endothelium-dependent Vasodilation in Human Gingiva

Investigation of Endothelium-dependent Vasodilation in Human Gingiva Depending on Serum Estrogen Level

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06454084
Enrollment
80
Registered
2024-06-12
Start date
2023-09-01
Completion date
2025-12-31
Last updated
2024-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vasodilation, Oral Soft Tissue Conditions

Keywords

spreading vasodilation, gingival microcirculation, LSCI

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.

Interventions

Vasodilator solution

Sponsors

Semmelweis University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes

Inclusion criteria

* healthy systemic and periodontal conditions

Exclusion criteria

* systemic disease and medication * periodontal disease * smoking

Design outcomes

Primary

MeasureTime frameDescription
1. Blood flow change after applying the test solution19 minutesThe change in blood flow will be measured after applying the test solution

Countries

Hungary

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026