Blood Flow Analysis of the Human Mucosa After Vestibuloplasty Procedures

NCT ID: NCT02975024

Last Updated: 2018-04-18

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

Total Enrollment

8 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-30

Study Completion Date

2017-12-31

Brief Summary

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Apply the LSCI for follow-up the postoperative microcirculation after surgical procedures to enlarge keratinized gingiva in order to characterize the kinetics of the blood flow changes during wound healing in human subjects.

Detailed Description

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Vestibuloplasty is the common name of those procedures designed to widen the zone of attached gingiva. The apically repositioned split thickness flap with a xenogeneic collagen matrix or with a combination of strip gingival graft and a xenogeneic collagen matrix are frequently used surgical techniques, however no data are available, how these graft tissues affect the microcirculation of the healing gingiva.

LSCI is a non-invasive, two dimensional method to evaluate microcirculation of different tissues. This new method let us monitor the entire surgical area real-time during the healing period.

The aim of the present study is to define blood flow patterns, which might characterize the wound healing of such surgical procedures during the first 6 months of healing in order to facilitate treatment.

Conditions

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Mucogingival Defect

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Mucograft

Laser speckle contrast imaging of the oral mucosa and wound fluid measurement and quantitative determination of VEGF after mandibular vestibuloplasty. Individuals of this pre-defined group are candidates of vestibuloplasty, where the keratinized gingiva will be enlarged by a combination of apically repositioned split thickness flap with a xenogeneic collagen matrix (Mucograft).

laser speckle contrast imaging of the oral mucosa

Intervention Type DEVICE

Non-invasive method to measure tissue blood perfusion applied for oral mucosa

wound fluid measurement

Intervention Type DEVICE

Wound fluid at the wound margin is collected using filter strip and volumetrically measured by Periotron 8010 instrument.

quantitative determination of VEGF

Intervention Type DEVICE

For the quantitative determination of VEGF in the fourth day wound fluid sample the Human VEGF Quantikine ELISA Kit will be used.

strip gingival graft + Mucograft

Laser speckle contrast imaging of the oral mucosa and wound fluid measurement and quantitative determination of VEGF after mandibular vestibuloplasty. Individuals of this pre-defined group are candidates of vestibuloplasty, where the keratinized gingiva will be enlarged by a combination of apically repositioned split thickness flap with a strip gingival graft and a xenogeneic collagen matrix (Mucograft). The strip gingival graft is harvested from the patient's palate.

laser speckle contrast imaging of the oral mucosa

Intervention Type DEVICE

Non-invasive method to measure tissue blood perfusion applied for oral mucosa

wound fluid measurement

Intervention Type DEVICE

Wound fluid at the wound margin is collected using filter strip and volumetrically measured by Periotron 8010 instrument.

quantitative determination of VEGF

Intervention Type DEVICE

For the quantitative determination of VEGF in the fourth day wound fluid sample the Human VEGF Quantikine ELISA Kit will be used.

Interventions

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laser speckle contrast imaging of the oral mucosa

Non-invasive method to measure tissue blood perfusion applied for oral mucosa

Intervention Type DEVICE

wound fluid measurement

Wound fluid at the wound margin is collected using filter strip and volumetrically measured by Periotron 8010 instrument.

Intervention Type DEVICE

quantitative determination of VEGF

For the quantitative determination of VEGF in the fourth day wound fluid sample the Human VEGF Quantikine ELISA Kit will be used.

Intervention Type DEVICE

Other Intervention Names

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LSCI Perimed PSI Periotron 8010 Human VEGF Quantikine ELISA Kit

Eligibility Criteria

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Inclusion Criteria

• clinical diagnosis of inadequate width of keratinized gingiva at the mandibular front region

Exclusion Criteria

* pregnancy
* heavy smoking
* general diseases
* taking medications or having treatments which have an effect on mucosal healing in general (e.g. steroids, anti-inflammatory drugs)
* taking any other medications in the last three months (except contraceptives)
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hungarian Scientific Research Fund

UNKNOWN

Sponsor Role collaborator

Semmelweis University

OTHER

Sponsor Role lead

Responsible Party

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Dr. Vag Janos

associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Janos Vag

Role: PRINCIPAL_INVESTIGATOR

Semmelweis University, Dept. of Conservative Dentistry

Locations

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Janos Vag

Budapest, , Hungary

Site Status

Countries

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Hungary

Other Identifiers

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3/2013

Identifier Type: -

Identifier Source: org_study_id

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