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

NCT ID: NCT02552498

Last Updated: 2018-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-09-30

Brief Summary

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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

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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

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Ischemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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vertical

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.

Group Type EXPERIMENTAL

strangulation

Intervention Type PROCEDURE

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.

horizontal

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.

Group Type EXPERIMENTAL

strangulation

Intervention Type PROCEDURE

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.

papilla base

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.

Group Type EXPERIMENTAL

strangulation

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* general good health

Exclusion Criteria

* pregnancy
* smoking
* general diseases
* medicine taking except contraceptives
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Semmelweis University

OTHER

Sponsor Role lead

Responsible Party

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Dr. Vag Janos

associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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2/2013

Identifier Type: -

Identifier Source: org_study_id

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