VasodilatationNCT04918563
Endothelium Dependent and Non-dependent Vasodilatation in Human Gingiva
A study testing Nitroglycerin and Acetylcholine in people with Vasodilatation and Oral Soft Tissue Conditions, run by Semmelweis University at 1 site in Hungary.
Trial summary
The aim of this study is to compare the endothelim-dependent and non-dependent vasodilatation between genders in the human gingiva. Read more about this study
- Who is it for?
- Ages 20 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Vasodilatation, Oral Soft Tissue Conditions
- What is being tested?
- Nitroglycerin and Acetylcholine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteHungary
- Study dates
- 15 Sep 2020to 15 May 2021
- 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 20 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- general health
- minimum 5 mm keratinized gingiva at the upper front teeth
- good oral hygiene
Who cannot join
- pregnancy and breast-feeding
- smoking
- medication
- insufficient marginal integrity
- periodontitis
- caries
Trial locations and contacts
1 site in 1 country.
Hungary1 site
Semmelweis University, Department of Conservative Dentistry
Budapest, 1088
About this study
Official title: Investigation of the Endothel Dependent and Independent Vasodilatation in Human Gingiva: Comparison of the Effect of NO and ACH
The aim of this study is to compare the endothelim-dependent and non-dependent vasodilatation between genders in the human gingiva.
Read the detailed description
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
- Vasodilatation, Oral Soft Tissue Conditions
- Being tested
- Nitroglycerin, Acetylcholine
- Keywords
- spreading vasodilatation, gingial microcirculation, LSCI
- 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 labial surface on the lateral incisor, so it can penetrate through the sulcus.
AcetylcholineDrug
Also called Ach
Vasodilatator solution is dropped on the labial surface on the lateral incisor, so it can penetrate through the sulcus.
| Study group | Role | What they receive |
|---|---|---|
| nitroglycerin | Active comparator | NO donor (Nitropohl) vs pgysiological saline
1mg/ml nitorhlycerin Receives: Drug: Nitroglycerin |
| acethylcholine | Active comparator | 10 mg/ml acetylcholine vs physiological saline Receives: Drug: Acetylcholine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood flow change after applying the test solutions
The change in blood flow will be measeured after applying the test solutions.
Measured: 20 minutes
Secondary outcomes (2)
Comparison the change in blood flow between the two solutions
The blood flow values will be evaluated after each applied solutions.
Measured: 30 minutes
Comparison the change in blood flow in genders
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.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start15 Sep 2020
- Primary completion15 Apr 2021
- Study completion15 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for VasodilatationStudies 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
- 24 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
- NCT04918563
- Sponsor's protocol ID
- 1/2020
- Status last verified
- Jun 2021
- First submitted
- 2 Jun 2021
- Last updated
- 14 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35562729
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Endothel Dependent and Independent Vasodilatation in Human Gingiva: Comparison of the Effect of NO and ACH
- ClinicalTrials.gov ID
- NCT04918563
- Acronym / sponsor ID
- 1/2020
- Conditions
- Vasodilatation, Oral Soft Tissue Conditions
- Keywords
- spreading vasodilatation, gingial microcirculation, LSCI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 15 Apr 2021 (actual)
- Study completion
- 15 May 2021 (actual)
- First posted
- 9 Jun 2021 (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 compare the endothelim-dependent and non-dependent vasodilatation between genders in the human gingiva.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nitroglycerin | Active comparator | Drug: NitroglycerinNO donor (Nitropohl) vs pgysiological saline 1mg/ml nitorhlycerin |
| acethylcholine | Active comparator | Drug: Acetylcholine10 mg/ml acetylcholine vs physiological saline |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- general health
- minimum 5 mm keratinized gingiva at the upper front teeth
- good oral hygiene
Key exclusion criteria (6 listed)
- pregnancy and breast-feeding
- smoking
- medication
- insufficient marginal integrity
- periodontitis
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 labial surface on the lateral incisor, so it can penetrate through the sulcus. | Drug | nitroglycerin |
| AcetylcholineAlso: AchVasodilatator solution is dropped on the labial surface on the lateral incisor, so it can penetrate through the sulcus. | Drug | acethylcholine |
Primary outcome
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.
2 secondary outcomes
Comparison the change in blood flow between the two solutions
Time frame: 30 minutes
Comparison the change in blood flow in genders
Time frame: 20 minutes
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 14 Jun 2021.
- Derived from this study: PubMed 35562729Vag 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.
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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 and Acetylcholine in people with Vasodilatation and Oral Soft Tissue Conditions, 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 3 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 14 Jun 2021. 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 applying the test solutions (time frame: 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04918563, which also lists 1 linked publication.
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 14 Jun 2021.