Post Occlusive Reactive Hyperemia on Gingiva Assessed by Laser Speckle Contrast Imaging
Primary Purpose
Ischemia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
strangulation
Sponsored by

About this trial
This is an interventional basic science trial for Ischemia
Eligibility Criteria
Inclusion Criteria:
- general good health
Exclusion Criteria:
- pregnancy
- smoking
- general diseases
- medicine taking except contraceptives
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
vertical
horizontal
papilla base
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02552498
First Posted
September 15, 2015
Last Updated
April 17, 2018
Sponsor
Semmelweis University
1. Study Identification
Unique Protocol Identification Number
NCT02552498
Brief Title
Post Occlusive Reactive Hyperemia on Gingiva Assessed by Laser Speckle Contrast Imaging
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Semmelweis University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemia
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
vertical
Arm Type
Experimental
Arm Description
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.
Arm Title
horizontal
Arm Type
Experimental
Arm Description
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.
Arm Title
papilla base
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
strangulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in blood flow during and after ischemia
Description
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.
Time Frame
baseline, at time of strangulation, and 30 second, 5,10,15,20 minute post-occlusal
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
general good health
Exclusion Criteria:
pregnancy
smoking
general diseases
medicine taking except contraceptives
12. IPD Sharing Statement
Learn more about this trial
Post Occlusive Reactive Hyperemia on Gingiva Assessed by Laser Speckle Contrast Imaging
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