NCT03605095

Brief Summary

The aim of this study is to observe the mechanism of spreading vasodilatation on human healthy gingiva. Nitric-oxide donor solutions in lower and higher concentration are used to trigger the vasoactivity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2018

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2018

Completed
14 days until next milestone

Study Start

First participant enrolled

July 25, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 30, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2018

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2018

Completed
Last Updated

September 11, 2018

Status Verified

September 1, 2018

Enrollment Period

1 month

First QC Date

July 11, 2018

Last Update Submit

September 10, 2018

Conditions

Nitric OxideVasodilationOral Soft Tissue Conditions

Keywords

spreading vasodilationgingival microcirculation

Outcome Measures

Primary Outcomes (1)

  • Blood flow change after application of NO agonist

    The change in blood flow will be measured after locally applied nitroglycerin at the site fo application and at the remote sites

    30 min

Secondary Outcomes (2)

  • Comparsion of the change in blood flow between genders

    30min

  • Correlation between the change in blood flow and gingival thickness

    30min

Study Arms (2)

8 mg/ml nitroglycerin

ACTIVE COMPARATOR

Higher concentration of NO donor (Nitromint) vs dilution

Drug: nitroglycerin

1 mg/ml nitroglycerin

ACTIVE COMPARATOR

Lower concentration of NO donor (Nitropohl) vs physiological saline

Drug: nitroglycerin

Interventions

nitroglycerinDRUG

Vasodilatator solution is dropped on the gingiva.

1 mg/ml nitroglycerin8 mg/ml nitroglycerin

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • general health
  • minimum 5 mm keratinized gingiva at upper front teeth

You may not qualify if:

  • pregnancy and breast-feeding
  • medication (except contraceptives)
  • smoking
  • periodontitis
  • caries
  • insufficient marginal integrity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Janos Vag

Budapest, 1088, Hungary

Location

MeSH Terms

Conditions

Aneurysm

Interventions

Nitroglycerin

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Nitro CompoundsOrganic Chemicals

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
Principal Investigator

Study Record Dates

First Submitted

July 11, 2018

First Posted

July 30, 2018

Study Start

July 25, 2018

Primary Completion

August 30, 2018

Study Completion

September 10, 2018

Last Updated

September 11, 2018

Record last verified: 2018-09

Locations

HU(1)