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Clinical trial

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

ID
Name
2023/2025
Description
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.
Trial arms
Trial start
2023-09-01
Estimated PCD
2024-12-31
Trial end
2025-12-31
Status
Active (not recruiting)
Treatment
Acetylcholine Chloride
Vasodilator solution
Arms:
Acetylcholine 0,1 mg/mL and 1 mg/mL and 10 mg/mL
Size
80
Primary endpoint
1. Blood flow change after applying the test solution
19 minutes
Eligibility criteria
Inclusion Criteria: * healthy systemic and periodontal conditions Exclusion Criteria: * systemic disease and medication * periodontal disease * smoking
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 80, 'type': 'ESTIMATED'}}
Updated at
2024-06-12

1 organization

1 product

2 indications

Organization
Semmelweis University
Product
Acetylcholine
Indication
Vasodilation
Indication
Oral Soft Tissue Conditions