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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
Semmelweis University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Ischemia

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    September 15, 2015
    Last Updated
    April 17, 2018
    Sponsor
    Semmelweis University
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    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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