Investigation of Endothelium-dependent Vasodilation in Human Gingiva

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Vasodilation; Oral Soft Tissue Conditions
• Intervention / Treatment: Drug: Acetylcholine Chloride

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 Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hungary
  • Budapest, Hungary, 1088
    • Department for Restorative Dentistry and Endodontics, Semmelweis University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• healthy systemic and periodontal conditions

Exclusion Criteria:

• systemic disease and medication
• periodontal disease
• smoking

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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

Drug: Acetylcholine Chloride; Vasodilator solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1. Blood flow change after applying the test solution	The change in blood flow will be measured after applying the test solution	19 minutes

Collaborators and Investigators

• Sponsor: Semmelweis University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: June 6, 2024
• First Submitted That Met QC Criteria: June 6, 2024
• First Posted (Actual): June 12, 2024

Study Record Updates

• Last Update Posted (Actual): June 12, 2024
• Last Update Submitted That Met QC Criteria: June 6, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: LSCI; gingival microcirculation; spreading vasodilation
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Cholinergic Agents; Cholinergic Agonists; Acetylcholine
• Other Study ID Numbers: 2023/2025

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No