Investigation of Endothelium-dependent Vasodilation in Human Gingiva

NCT06454084 | Active Not Recruiting

• 1 other identifier: 2023/2025
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Vasodilation; Oral Soft Tissue Conditions

Keywords

spreading vasodilation; gingival microcirculation; LSCI

Outcome Measures

Primary Outcomes (1)

• 1. Blood flow change after applying the test solution

  The change in blood flow will be measured after applying the test solution

  19 minutes

Study Arms (1)

Acetylcholine 0,1 mg/mL and 1 mg/mL and 10 mg/mL

EXPERIMENTAL

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

Interventions

Acetylcholine Chloride DRUG

Vasodilator solution

Acetylcholine 0,1 mg/mL and 1 mg/mL and 10 mg/mL

Eligibility Criteria

• Age: 18 Years - 90 Years
• Gender Eligibility Details: women and men
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy systemic and periodontal conditions

You may not qualify if:

• systemic disease and medication
• periodontal disease
• smoking

Sponsors & Collaborators

• Semmelweis University: lead

Study Sites (1)

Department for Restorative Dentistry and Endodontics, Semmelweis University

Budapest, 1088, Hungary

Location

MeSH Terms

Conditions

Aneurysm

Interventions

Acetylcholine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biogenic Amines; Amines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: June 6, 2024
• First Posted: June 12, 2024
• Study Start: September 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: June 12, 2024

Record last verified: 2024-06

Locations

HU (1)