NCT02552498

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 17, 2015

Completed
14 days until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

April 19, 2018

Status Verified

April 1, 2018

Enrollment Period

4 months

First QC Date

September 15, 2015

Last Update Submit

April 17, 2018

Conditions

Ischemia

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

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.

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.

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.

Procedure: strangulation

Interventions

strangulationPROCEDURE

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.

horizontalpapilla basevertical

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • general good health

You may not qualify if:

  • pregnancy
  • smoking
  • general diseases
  • medicine taking except contraceptives

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Ischemia

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

September 15, 2015

First Posted

September 17, 2015

Study Start

October 1, 2015

Primary Completion

February 1, 2016

Study Completion

September 1, 2016

Last Updated

April 19, 2018

Record last verified: 2018-04