Investigation of Endothelium-dependent Vasodilation in Human Gingiva

NCT ID: NCT06454084

Last Updated: 2024-06-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2025-12-31

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.

Conditions

Vasodilation; Oral Soft Tissue Conditions

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Acetylcholine Chloride

Intervention Type: DRUG

Vasodilator solution

Interventions

Acetylcholine Chloride

Vasodilator solution

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• healthy systemic and periodontal conditions

Exclusion Criteria

• systemic disease and medication
• periodontal disease
• smoking

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Semmelweis University

OTHER

Sponsor Role: lead

Responsible Party

Dr. Vag Janos

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department for Restorative Dentistry and Endodontics, Semmelweis University

Budapest, , Hungary

Countries

Hungary

Other Identifiers

2023/2025

Identifier Type: -

Identifier Source: org_study_id