Endothelium Dependent and Non-dependent Vasodilatation in Human Gingiva

NCT ID: NCT04918563

Last Updated: 2021-06-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-15

Study Completion Date

2021-05-15

Brief Summary

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

Detailed Description

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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.

Conditions

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Vasodilatation Oral Soft Tissue Conditions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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nitroglycerin

NO donor (Nitropohl) vs pgysiological saline

1mg/ml nitorhlycerin

Group Type ACTIVE_COMPARATOR

Nitroglycerin

Intervention Type DRUG

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

acethylcholine

10 mg/ml acetylcholine vs physiological saline

Group Type ACTIVE_COMPARATOR

Acetylcholine

Intervention Type DRUG

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

Interventions

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Nitroglycerin

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

Intervention Type DRUG

Acetylcholine

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

Intervention Type DRUG

Other Intervention Names

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Ach

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Semmelweis University

OTHER

Sponsor Role lead

Responsible Party

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Dr. Vag Janos

associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Semmelweis University, Department of Conservative Dentistry

Budapest, , Hungary

Site Status

Countries

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Hungary

References

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Vag J, Nagy TL, Mikecs B. Sex-related differences in endothelium-dependent vasodilation of human gingiva. BMC Oral Health. 2022 May 13;22(1):177. doi: 10.1186/s12903-022-02186-2.

Reference Type DERIVED
PMID: 35562729 (View on PubMed)

Other Identifiers

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1/2020

Identifier Type: -

Identifier Source: org_study_id

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