IschemiaNCT02552498
Post Occlusive Reactive Hyperemia on Gingiva Assessed by Laser Speckle Contrast Imaging
A study testing strangulation in people with Ischemia, run by Semmelweis University.
Trial summary
Apply the LASCA for follow-up the postocclusive microcirculation after strangulation of the gingiva in order to characterize the kinetics of the blood flow changes in human subjects. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Ischemia
- What is being tested?
- strangulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Sep 2016
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- general good health
Who cannot join
- pregnancy
- smoking
- general diseases
- medicine taking except contraceptives
About this study
Apply the LASCA for follow-up the postocclusive microcirculation after strangulation of the gingiva in order to characterize the kinetics of the blood flow changes in human subjects.
Read the detailed description
During surgical endodontics the cortical bone is exposed by elevating a full- thickness tissue flap. Cutting across mucosal blood vessels disturbs perfusion and causes ischemia. On the other hand, preserving sufficient blood flow of the soft tissue segment is important for the postoperative wound healing. In order to minimize the damage of the microvasculature of the operated area, the incision should be properly designed.
The investigators will model surgical incisions by strangulation of the gingiva of healthy human subjects based on the commonly applied endodontic incision such as horizontal, vertical and papilla base. The primary aim is to determine the effect of a short term disruption of the blood flow at the respective region on the surrounding area in order to assess the functionally active collateral circulation. Using Laser Speckle Contrast Analysis (LASCA), which provides blood perfusion data, the investigators will have the possibility to detect functional alterations in gingival microcirculation during and after a short term of strangulation. The secondary aim is to assess the time course of the restoration of the circulation on the affected area.
- Conditions
- Ischemia
- Being tested
- strangulation
- Medical subject headings
- Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
strangulationProcedure or surgery
The strangulation is applied on the attached gingiva with an angulated manual instrument. The force of the occlusion is standardized by a calibrated spring connecting the head with the handle of the tool. The head is overlaid onto the gingiva covering 10mm long and 1mm width surface. The amount of the applied pressure is 100 gram.
| Study group | Role | What they receive |
|---|---|---|
| vertical | Experimental | Strangulation is applied on the the buccal side of the attached gingiva, parallel to the long axis of tooth 12, at the distal third of the tooth. Receives: Procedure: strangulation |
| horizontal | Experimental | Strangulation is applied on the buccal side of the attached gingiva, perpendicular to the long axis of the tooth 12, 2 mm far from the gingival margin. Receives: Procedure: strangulation |
| papilla base | Experimental | Strangulation is applied on the the buccal side of the attached gingiva, on the base of the mesial papilla of tooth 12, in straight line going from one side of papilla to the other. Receives: Procedure: strangulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in blood flow during and after ischemia
The blood flow changes are measured by Laser Speckle Contrast Analyzer (LASCA) before (baseline), during and after strangulation. The scale is an arbitrary unit (0-3000 LSPU) and the relative changes to the baseline measurement will be calculate. The blood flow is recorded for 30min.
Measured: baseline, at time of strangulation, and 30 second, 5,10,15,20 minute post-occlusal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2015 (estimated)
- Study startOct 2015
- Primary completionFeb 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IschemiaStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 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
- NCT02552498
- Sponsor's protocol ID
- 2/2013
- Status last verified
- Apr 2018
- First submitted
- 15 Sep 2015
- Last updated
- 19 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Occlusive Reactive Hyperemia on Gingiva Assessed by Laser Speckle Contrast Imaging
- ClinicalTrials.gov ID
- NCT02552498
- Acronym / sponsor ID
- 2/2013
- Conditions
- Ischemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 17 Sep 2015 (estimated)
- 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.
Apply the LASCA for follow-up the postocclusive microcirculation after strangulation of the gingiva in order to characterize the kinetics of the blood flow changes in human subjects.
Detailed description
During surgical endodontics the cortical bone is exposed by elevating a full- thickness tissue flap. Cutting across mucosal blood vessels disturbs perfusion and causes ischemia. On the other hand, preserving sufficient blood flow of the soft tissue segment is important for the postoperative wound healing. In order to minimize the damage of the microvasculature of the operated area, the incision should be properly designed.
The investigators will model surgical incisions by strangulation of the gingiva of healthy human subjects based on the commonly applied endodontic incision such as horizontal, vertical and papilla base. The primary aim is to determine the effect of a short term disruption of the blood flow at the respective region on the surrounding area in order to assess the functionally active collateral circulation. Using Laser Speckle Contrast Analysis (LASCA), which provides blood perfusion data, the investigators will have the possibility to detect functional alterations in gingival microcirculation during and after a short term of strangulation. The secondary aim is to assess the time course of the restoration of the circulation on the affected area.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| vertical | Experimental | Procedure: strangulationStrangulation is applied on the the buccal side of the attached gingiva, parallel to the long axis of tooth 12, at the distal third of the tooth. |
| horizontal | Experimental | Procedure: strangulationStrangulation is applied on the buccal side of the attached gingiva, perpendicular to the long axis of the tooth 12, 2 mm far from the gingival margin. |
| papilla base | Experimental | Procedure: strangulationStrangulation is applied on the the buccal side of the attached gingiva, on the base of the mesial papilla of tooth 12, in straight line going from one side of papilla to the other. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- general good health
Key exclusion criteria (4 listed)
- pregnancy
- smoking
- general diseases
- medicine taking except contraceptives
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 |
|---|---|---|
| strangulationThe strangulation is applied on the attached gingiva with an angulated manual instrument. The force of the occlusion is standardized by a calibrated spring connecting the head with the handle of the tool. The head is overlaid onto the gingiva covering 10mm long and 1mm width surface. The amount of the applied pressure is 100 gram. | Procedure or surgery | horizontal, papilla base, vertical |
Primary outcome
Change from baseline in blood flow during and after ischemia
Time frame: baseline, at time of strangulation, and 30 second, 5,10,15,20 minute post-occlusal
The blood flow changes are measured by Laser Speckle Contrast Analyzer (LASCA) before (baseline), during and after strangulation. The scale is an arbitrary unit (0-3000 LSPU) and the relative changes to the baseline measurement will be calculate. The blood flow is recorded for 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 19 Apr 2018.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing strangulation in people with Ischemia, run by Semmelweis University.
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 1 inclusion and 4 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 19 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Change from baseline in blood flow during and after ischemia (time frame: baseline, at time of strangulation, and 30 second, 5,10,15,20 minute post-occlusal). 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 19 Apr 2018.