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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04918563
Other study ID # 1/2020
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 15, 2020
Est. completion date May 15, 2021

Study information

Verified date June 2021
Source Semmelweis University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to compare the endothelim-dependent and non-dependent vasodilatation between genders in the human gingiva.


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 Spackle Contrast Imaging is a reliable tool. It has good reproducibility, it doesn't get in touch with the measured surface, it's easy to use and it can measure on a bigger surface in same time. Two wells were fabricated on the labial surface of the right lateral incisor (test tooth) and on the labial surface of the left central incisor (control tooth). These wells are opened towards the high-prermeability gingival sulcus, so the dropped solutions nitroglycerine vs physiological saline or nitroglycerine vs physiological saline can esasily penetrate to the gingival tissues. After applying the solutions, the blood flow was monitored fot 15 minutes.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date May 15, 2021
Est. primary completion date April 15, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 30 Years
Eligibility Inclusion Criteria: - general health - minimum 5 mm keratinized gingiva at the upper front teeth - good oral hygiene Exclusion Criteria: - pregnancy and breast-feeding - smoking - medication - insufficient marginal integrity - periodontitis - caries

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Nitroglycerin
Vasodilatator solution is dropped on the labial surface on the lateral incisor, so it can penetrate through the sulcus.
Acetylcholine
Vasodilatator solution is dropped on the labial surface on the lateral incisor, so it can penetrate through the sulcus.

Locations

Country Name City State
Hungary Semmelweis University, Department of Conservative Dentistry Budapest

Sponsors (1)

Lead Sponsor Collaborator
Semmelweis University

Country where clinical trial is conducted

Hungary, 

Outcome

Type Measure Description Time frame Safety issue
Primary Blood flow change after applying the test solutions The change in blood flow will be measeured after applying the test solutions. 20 minutes
Secondary Comparison the change in blood flow between the two solutions The blood flow values will be evaluated after each applied solutions. 30 minutes
Secondary Comparison the change in blood flow in genders The maximal blood flow changes assessed in primary outcome will be split into two groups based on gender. The change will be compared between males and females. 20 minutes
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