Nitric OxideNCT03605095
Evidence of Spreading Vasodilation in Human Gingiva
A study testing nitroglycerin in people with Nitric Oxide and Vasodilation, run by Semmelweis University at 1 site in Hungary.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Nitric Oxide, Vasodilation, Oral Soft Tissue Conditions
- What is being tested?
- nitroglycerin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteHungary
- Study dates
- 25 Jul 2018to 10 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- general health
- minimum 5 mm keratinized gingiva at upper front teeth
Who cannot join
- pregnancy and breast-feeding
- medication (except contraceptives)
- smoking
- periodontitis
- caries
- insufficient marginal integrity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-invasive Imaging of Human Gingival Microcirculation: Effect of Nitric Oxide
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.
Read the detailed description
Spatial regulation of gingival microcirculation has not been revealed yet. Although this could be an important mechanism to protect gingiva as it is exposed to mechanical, chemical, thermal etc. irritation during whole life. It is especially important during flap surgery. Laser Speckle Contrast Imaging (LSCI) is novel non-invasive method with high spatio-temporal resolution, therefore it allows us to study remote effect of local vasodilation such as spreading vasodilation in human gingiva.
The vasodilatator nitric-oxide (NO) donor will be used to trigger remote effect on gingiva. NO donor solutions will be applied in 1 mg/ml and 8 mg/ml nitroglycerin concentrations. Solution will be dropped on the gingiva at tooth 12 in a fabricated leakage proof well attached to 2mm above the marginal gingiva. The change on blood flow will be monitor at the test well with surrounding gingival area spanning 3 tooth and at the contralateral side by LSCI.
- Conditions
- Nitric Oxide, Vasodilation, Oral Soft Tissue Conditions
- Being tested
- nitroglycerin
- Keywords
- spreading vasodilation, gingival microcirculation
- Medical subject headings
- Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nitroglycerinDrug
Vasodilatator solution is dropped on the gingiva.
| Study group | Role | What they receive |
|---|---|---|
| 8 mg/ml nitroglycerin | Active comparator | Higher concentration of NO donor (Nitromint) vs dilution Receives: Drug: nitroglycerin |
| 1 mg/ml nitroglycerin | Active comparator | Lower concentration of NO donor (Nitropohl) vs physiological saline Receives: Drug: nitroglycerin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 min
Secondary outcomes (2)
Comparsion of the change in blood flow between genders
The maximal blood flow changed assessed in primary outcome will be split into two groups based on gender. The change will be compared between males and females.
Measured: 30min
Correlation between the change in blood flow and gingival thickness
The biotpye will be assessed by measurement of gingival thickness by an ultrasonic devices. The correlation between thickness and maximal vasodilation will be evaluated.
Measured: 30min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2018
- Study start25 Jul 2018
- Primary completion30 Aug 2018
- Study completion10 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nitric OxideStudies of the same condition, open and under way.
- More trials run by Semmelweis UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Vag Janos, Semmelweis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03605095
- Sponsor's protocol ID
- 5/2018
- Status last verified
- Sep 2018
- First submitted
- 11 Jul 2018
- Last updated
- 11 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Imaging of Human Gingival Microcirculation: Effect of Nitric Oxide
- ClinicalTrials.gov ID
- NCT03605095
- Acronym / sponsor ID
- 5/2018
- Conditions
- Nitric Oxide, Vasodilation, Oral Soft Tissue Conditions
- Keywords
- spreading vasodilation, gingival microcirculation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Study start
- 25 Jul 2018 (actual)
- Primary completion
- 30 Aug 2018 (actual)
- Study completion
- 10 Sep 2018 (actual)
- First posted
- 30 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Spatial regulation of gingival microcirculation has not been revealed yet. Although this could be an important mechanism to protect gingiva as it is exposed to mechanical, chemical, thermal etc. irritation during whole life. It is especially important during flap surgery. Laser Speckle Contrast Imaging (LSCI) is novel non-invasive method with high spatio-temporal resolution, therefore it allows us to study remote effect of local vasodilation such as spreading vasodilation in human gingiva.
The vasodilatator nitric-oxide (NO) donor will be used to trigger remote effect on gingiva. NO donor solutions will be applied in 1 mg/ml and 8 mg/ml nitroglycerin concentrations. Solution will be dropped on the gingiva at tooth 12 in a fabricated leakage proof well attached to 2mm above the marginal gingiva. The change on blood flow will be monitor at the test well with surrounding gingival area spanning 3 tooth and at the contralateral side by LSCI.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 8 mg/ml nitroglycerin | Active comparator | Drug: nitroglycerinHigher concentration of NO donor (Nitromint) vs dilution |
| 1 mg/ml nitroglycerin | Active comparator | Drug: nitroglycerinLower concentration of NO donor (Nitropohl) vs physiological saline |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- general health
- minimum 5 mm keratinized gingiva at upper front teeth
Key exclusion criteria (6 listed)
- pregnancy and breast-feeding
- medication (except contraceptives)
- smoking
- periodontitis
- caries
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nitroglycerinVasodilatator solution is dropped on the gingiva. | Drug | 1 mg/ml nitroglycerin, 8 mg/ml nitroglycerin |
Primary outcome
Blood flow change after application of NO agonist
Time frame: 30 min
The change in blood flow will be measured after locally applied nitroglycerin at the site fo application and at the remote sites
2 secondary outcomes
Comparsion of the change in blood flow between genders
Time frame: 30min
Correlation between the change in blood flow and gingival thickness
Time frame: 30min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nitroglycerin in people with Nitric Oxide and Vasodilation, run by Semmelweis University at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood flow change after application of NO agonist (time frame: 30 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2018.