Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06454084
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-06-06
Brief Title:
Investigation of Endothelium-dependent Vasodilation in Human Gingiva
Sponsor:
Semmelweis University
Organization:
Semmelweis University
Study Overview
Official Title:
Investigation of Endothelium-dependent Vasodilation in Human Gingiva Depending on Serum Estrogen Level
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 studys second phase blood sampling is taken before the gingival blood flow measurement
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 studys second phase blood sampling is taken before the gingival blood flow measurement
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None