Investigation of Endothelium-dependent Vasodilation in Human Gingiva

Not Applicable

Active, not recruiting

• Conditions: Vasodilation; Oral Soft Tissue Conditions
• Interventions: Drug: Acetylcholine Chloride

• Registration Number: NCT06454084
• Lead Sponsor: Semmelweis University

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 Timeline

• Study Start: 2023-09-01
• Status Verified: 2024-06
• Study First Submitted: 2024-06-06
• Study First Submitted QC: 2024-06-06
• Last Update Submitted: 2024-06-06
• Study First Posted: 2024-06-12
• Last Update Posted: 2024-06-12
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• healthy systemic and periodontal conditions

Exclusion Criteria

• systemic disease and medication
• periodontal disease
• smoking

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Acetylcholine 0,1 mg/mL and 1 mg/mL and 10 mg/mL	Acetylcholine Chloride	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

Primary Outcome Measures

Name	Time	Method
1. Blood flow change after applying the test solution	19 minutes	The change in blood flow will be measured after applying the test solution

Trial Locations

Locations (1)

Department for Restorative Dentistry and Endodontics, Semmelweis University; 🇭🇺 Budapest, Hungary