Endothelium Dependent and Non-dependent Vasodilatation in Human Gingiva

Oral Soft Tissue Conditions Clinical Trial

Official title:

Investigation of the Endothel Dependent and Independent Vasodilatation in Human Gingiva: Comparison of the Effect of NO and ACH

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04918563
• Other study ID #: 1/2020
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Oral Soft Tissue Conditions
• Vasodilatation

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