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Completed

NCT Number: NCT04918563

Endothelium Dependent and Non-dependent Vasodilatation in Human Gingiva

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

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Key information

Conditions

Vasodilatation Aneurysm Cardiovascular Diseases Oral Soft Tissue Conditions Vascular Diseases

Age range

20 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Semmelweis University, Department of Conservative Dentistry

Budapest, 1088, Hungary

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nitroglycerin

Drug

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

Acetylcholine

Drug

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

Other names: Ach

Primary outcomes

  1. Blood flow change after applying the test solutions

    Time frame: 20 minutes

    The change in blood flow will be measeured after applying the test solutions.

Secondary outcomes

  1. Comparison the change in blood flow between the two solutions

    Time frame: 30 minutes

    The blood flow values will be evaluated after each applied solutions.

  2. Comparison the change in blood flow in genders

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Semmelweis University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 9, 2021
Registry last updated
Jun 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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