Post Occlusive Reactive Hyperemia on Gingiva Assessed by Laser Speckle Contrast Imaging

Ischemia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02552498
• Other study ID #: 2/2013
• Status: Completed
• Phase: N/A
• First received: September 15, 2015
• Last updated: April 17, 2018
• Start date: October 2015
• Est. completion date: September 2016

Study information

• Verified date: April 2018
• Source: Semmelweis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: September 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• general good health

Exclusion Criteria:

• pregnancy

• smoking

• general diseases

• medicine taking except contraceptives

Related Conditions & MeSH terms

• Ischemia

Intervention

Procedure:
• strangulation
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Semmelweis University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline, at time of strangulation, and 30 second, 5,10,15,20 minute post-occlusal