Investigation of Endothelium-dependent Vasodilation in Human Gingiva

Vasodilation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06454084
• Other study ID #: 2023/2025
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2024
• Source: Semmelweis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• healthy systemic and periodontal conditions

Exclusion Criteria:

• systemic disease and medication
• periodontal disease
• smoking

Related Conditions & MeSH terms

• Oral Soft Tissue Conditions
• Vasodilation

Intervention

Drug:
• Acetylcholine Chloride
Vasodilator solution

Locations

Country	Name	City	State
Hungary	Department for Restorative Dentistry and Endodontics, Semmelweis University	Budapest

Sponsors (1)

Lead Sponsor	Collaborator
Semmelweis University

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1. Blood flow change after applying the test solution	The change in blood flow will be measured after applying the test solution	19 minutes