NCT04918563

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2021

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

June 2, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 9, 2021

Completed
Last Updated

June 14, 2021

Status Verified

June 1, 2021

Enrollment Period

7 months

First QC Date

June 2, 2021

Last Update Submit

June 9, 2021

Conditions

VasodilatationOral Soft Tissue Conditions

Keywords

spreading vasodilatationgingial microcirculationLSCI

Outcome Measures

Primary Outcomes (1)

  • Blood flow change after applying the test solutions

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

    20 minutes

Secondary Outcomes (2)

  • Comparison the change in blood flow between the two solutions

    30 minutes

  • Comparison the change in blood flow in genders

    20 minutes

Study Arms (2)

nitroglycerin

ACTIVE COMPARATOR

NO donor (Nitropohl) vs pgysiological saline 1mg/ml nitorhlycerin

Drug: Nitroglycerin

acethylcholine

ACTIVE COMPARATOR

10 mg/ml acetylcholine vs physiological saline

Drug: Acetylcholine

Interventions

NitroglycerinDRUG

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

nitroglycerin
AcetylcholineDRUG

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

Also known as: Ach
acethylcholine

Eligibility Criteria

Age20 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • general health
  • minimum 5 mm keratinized gingiva at the upper front teeth
  • good oral hygiene

You may not qualify if:

  • pregnancy and breast-feeding
  • smoking
  • medication
  • insufficient marginal integrity
  • periodontitis
  • caries

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Semmelweis University, Department of Conservative Dentistry

Budapest, 1088, Hungary

Location

Related Publications (1)

  • 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.

    PMID: 35562729DERIVED

MeSH Terms

Conditions

Aneurysm

Interventions

NitroglycerinAcetylcholine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Nitro CompoundsOrganic ChemicalsBiogenic AminesAmines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

June 2, 2021

First Posted

June 9, 2021

Study Start

September 15, 2020

Primary Completion

April 15, 2021

Study Completion

May 15, 2021

Last Updated

June 14, 2021

Record last verified: 2021-06

Locations

HU(1)