Endothelium Dependent and Non-dependent Vasodilatation in Human Gingiva

Not Applicable

Completed

• Conditions: Vasodilatation; Oral Soft Tissue Conditions
• Interventions: Drug: Nitroglycerin; Drug: Acetylcholine

• Registration Number: NCT04918563
• Lead Sponsor: Semmelweis University

Brief Summary

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

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 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.

Study Timeline

• Study Start: 2020-09-15
• Primary Completion: 2021-04-15
• Study Completion: 2021-05-15
• Status Verified: 2021-06
• Study First Submitted: 2021-06-02
• Study First Submitted QC: 2021-06-02
• Study First Posted: 2021-06-09
• Last Update Submitted: 2021-06-09
• Last Update Posted: 2021-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
nitroglycerin	Nitroglycerin	NO donor (Nitropohl) vs pgysiological saline 1mg/ml nitorhlycerin
acethylcholine	Acetylcholine	10 mg/ml acetylcholine vs physiological saline

Primary Outcome Measures

Name	Time	Method
Blood flow change after applying the test solutions	20 minutes	The change in blood flow will be measeured after applying the test solutions.

Secondary Outcome Measures

Name	Time	Method
Comparison the change in blood flow between the two solutions	30 minutes	The blood flow values will be evaluated after each applied solutions.
Comparison the change in blood flow in genders	20 minutes	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.

Trial Locations

Locations (1)

Semmelweis University, Department of Conservative Dentistry; 🇭🇺 Budapest, Hungary