VasoconstrictionNCT04131283
Evidence of Spreading Vasoconstriction in Human Gingiva
A study testing Epinephrine in people with Vasoconstriction and Oral Soft Tissue Conditions, run by Semmelweis University at 1 site in Hungary.
Trial summary
The aim of this study is to observe the mechanism of spreading vasoconstriction in human healthy gingiva. Epinephrine solution is applied on the attached gingiva in group "A" and on the surface of the tooth next to the ginvial sulcus in group "B". Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Vasoconstriction, Oral Soft Tissue Conditions, Dental and Gingival Conditions
- What is being tested?
- Epinephrine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteHungary
- Study dates
- 1 May 2019to 1 Jan 2020
- 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
- at least 5 mm keratinized gingiva at the upper front teeth
- general health
Who cannot join
- pregnancy, breast-feeding
- any medication
- smoking, gingivitis, caries and coronal restoration with insufficient marginal integrity
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to observe the mechanism of spreading vasoconstriction in human healthy gingiva. Epinephrine solution is applied on the attached gingiva in group "A" and on the surface of the tooth next to the ginvial sulcus in group "B". The different placement of the solution causes different effect in the microcirculation.
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 vasoconstriction such as spreading vasoconstriction in human gingiva.
The epinephrine is a daily used vasoconstrictor material in dentistry and it will be used to trigger remote effect on gingiva. Epinephrine in 1 mg/ml concentration. Solution will be dropped on the gingiva at tooth 12 in a fabricated leakage proof well attached to 2mm above the marginal gingiva in group "A". The solution will be dropped on the surface of tooth 12 next to the sulcus into the well in case of group "B". The changes of the blood flow will be monitor at the test side with surrounding gingival area by LSCI. The control side in each case will be - appropriately to the test side - at tooth 21 with phisiologocal saline.
- Being tested
- Epinephrine
- Keywords
- spreading vasoconstriction, gingival microcirculation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpinephrineDrug
Also called retrograde vasoconstriction
Vasoconstrictor solution is applied on the surface of the attached gingiva and on the gingival sulcus.
| Study group | Role | What they receive |
|---|---|---|
| Epinephrine effect throught keratinized ginigva | Experimental | 1 mg/ml epniephrine vs physiologocal saline Receives: Drug: Epinephrine |
| Epinephrine effect throught gingival sulcular epithelium | Experimental | 1 mg/ml epniephrine vs physiologocal saline Receives: Drug: Epinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood flow change after application of epinephrine
The change in blood flow will be measured after locally applied epinephrine at the site fo application and at the remote sites
Measured: 30 minutes
Secondary outcomes (1)
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: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2019
- Study start1 May 2019
- Primary completion1 Dec 2019
- Study completion1 Jan 2020
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 VasoconstrictionStudies 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
- 29 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
- NCT04131283
- Sponsor's protocol ID
- 1/2019
- Status last verified
- Jul 2020
- First submitted
- 16 Oct 2019
- Last updated
- 2 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Vag J, Ganti B, Mikecs B, Szabo E, Molnar B, Lohinai Z. Epinephrine penetrates through gingival sulcus unlike keratinized gingiva and evokes remote vasoconstriction in human. BMC Oral Health. 2020 Nov 4;20(1):305. doi: 10.1186/s12903-020-01296-z.
PubMed 33148235
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evidence of Spreading Vasoconstriction in Human Gingiva
- ClinicalTrials.gov ID
- NCT04131283
- Acronym / sponsor ID
- 1/2019
- Keywords
- spreading vasoconstriction, gingival microcirculation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 18 Oct 2019 (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 vasoconstriction in human healthy gingiva. Epinephrine solution is applied on the attached gingiva in group "A" and on the surface of the tooth next to the ginvial sulcus in group "B". The different placement of the solution causes different effect in the microcirculation.
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 vasoconstriction such as spreading vasoconstriction in human gingiva.
The epinephrine is a daily used vasoconstrictor material in dentistry and it will be used to trigger remote effect on gingiva. Epinephrine in 1 mg/ml concentration. Solution will be dropped on the gingiva at tooth 12 in a fabricated leakage proof well attached to 2mm above the marginal gingiva in group "A". The solution will be dropped on the surface of tooth 12 next to the sulcus into the well in case of group "B". The changes of the blood flow will be monitor at the test side with surrounding gingival area by LSCI. The control side in each case will be - appropriately to the test side - at tooth 21 with phisiologocal saline.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epinephrine effect throught keratinized ginigva | Experimental | Drug: Epinephrine1 mg/ml epniephrine vs physiologocal saline |
| Epinephrine effect throught gingival sulcular epithelium | Experimental | Drug: Epinephrine1 mg/ml epniephrine vs physiologocal saline |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- at least 5 mm keratinized gingiva at the upper front teeth
- general health
Key exclusion criteria (3 listed)
- pregnancy, breast-feeding
- any medication
- smoking, gingivitis, caries and coronal restoration with insufficient marginal integrity
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 |
|---|---|---|
| EpinephrineAlso: retrograde vasoconstrictionVasoconstrictor solution is applied on the surface of the attached gingiva and on the gingival sulcus. | Drug | Epinephrine effect throught gingival sulcular epithelium, Epinephrine effect throught keratinized ginigva |
Primary outcome
Blood flow change after application of epinephrine
Time frame: 30 minutes
The change in blood flow will be measured after locally applied epinephrine at the site fo application and at the remote sites
1 secondary outcome
Comparsion of the change in blood flow between genders
Time frame: 30 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 2 Jul 2020.
- Derived from this study: PubMed 33148235Vag J, Ganti B, Mikecs B, Szabo E, Molnar B, Lohinai Z. Epinephrine penetrates through gingival sulcus unlike keratinized gingiva and evokes remote vasoconstriction in human. BMC Oral Health. 2020 Nov 4;20(1):305. doi: 10.1186/s12903-020-01296-z.
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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 Epinephrine in people with Vasoconstriction 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 2 inclusion and 3 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 2 Jul 2020. 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 epinephrine (time frame: 30 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 NCT04131283, 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 2 Jul 2020.