Blood Flow Analysis of the Human Mucosa After Vestibuloplasty Procedures

April 17, 2018 updated by: Dr. Vag Janos, Semmelweis University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

8

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Budapest, Hungary, 1088
        • Janos Vag

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Caucasians subjects presenting multiple Miller Class I. and II. gingival recessions (Multiple Adjacent Recession Type Defects, MARTD) were recruited in the Department of Periodontology in Semmelweis University.

Description

Ages Eligible for Study: 18 Years to 45 Years Genders Eligible for Study: Both Accepts Healthy Volunteers: Yes

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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).
Device: laser speckle contrast imaging of the oral mucosa
Non-invasive method to measure tissue blood perfusion applied for oral mucosa
Other Names:
  • LSCI Perimed PSI
Device: wound fluid measurement
Wound fluid at the wound margin is collected using filter strip and volumetrically measured by Periotron 8010 instrument.
Other Names:
  • Periotron 8010
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.
Other Names:
  • Human VEGF Quantikine ELISA Kit
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.
Device: laser speckle contrast imaging of the oral mucosa
Non-invasive method to measure tissue blood perfusion applied for oral mucosa
Other Names:
  • LSCI Perimed PSI
Device: wound fluid measurement
Wound fluid at the wound margin is collected using filter strip and volumetrically measured by Periotron 8010 instrument.
Other Names:
  • Periotron 8010
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.
Other Names:
  • Human VEGF Quantikine ELISA Kit

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative blood flow changes of the oral mucosa
Time Frame: 6 months after surgery
Blood flow changes are measured by Laser Speckle Contrast Imager (LSCI) after mandibular vestibuloplasty. The scale is an arbitrary unit (0-3000 LSPU) and the relative changes to the surgically unaffected surrounding mucosa measurements are calculated. Postoperative follow-up time-points are: 1, 2, 3, 4, 5, 6, 7, 9, 11, 14, 21, 28 days, and 2, 3, 4, 5, 6 months. The apically repositioned split thickness flap is combined either with a Mucograft alone, or with a combination of autologous strip gingival graft and Mucograft. The differences in postoperative blood flow changes are compared between the two surgical techniques.
6 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wound fluid volume measurement
Time Frame: 14 days after surgery
Wound fluid sample is collected using a filter strip to withdraw the fluid around the wound. The filter strip is then inserted into Periotron 8010 instrument to score the volume on the paper. Scores are measured in an arbitrary unit. Postoperative follow-up time-points are: 1, 2, 3, 4, 5, 6, 7, 9, 11, 14 days. The apically repositioned split thickness flap is combined either with a Mucograft alone, or with a combination of autologous strip gingival graft and Mucograft. The differences in postoperative wound fluid changes are compared between the two surgical techniques.
14 days after surgery
Evaluation of the periodontal parameters at teeth at the surgical site: a composite outcome measure consisting of multiple measures.
Time Frame: Pre- and six month postoperative
Periodontal parameters are evaluated using a periodontal probe and will be expressed in mm. The following will be assessed at each tooth at the surgical site: probing depth, depth and width of recession, papilla height, and width and thickness of the keratinized gingiva. Surgical area is also measured apico-coronally and mesio-distally, during the whole follow-up period.
Pre- and six month postoperative
Quantitative determination of Vascular Endothelial Growth Factor (VEGF) of the wound fluid
Time Frame: 4 days after surgery
Wound fluid sample for VEGF is collected at the fourth postoperative day. For the quantitative determination of VEGF in samples the Human VEGF Quantikine ELISA Kit will be used. The apically repositioned split thickness flap is combined either with a Mucograft alone, or with a combination of autologous strip gingival graft and Mucograft. The differences in postoperative wound fluid level of VEGF (expressed in conc pg/mL) are compared between the two surgical techniques.
4 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Semmelweis University

Collaborators

Hungarian Scientific Research Fund

Investigators

  • Principal Investigator: Janos Vag, Semmelweis University, Dept. of Conservative Dentistry

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

November 16, 2016

First Submitted That Met QC Criteria

November 22, 2016

First Posted (Estimate)

November 29, 2016

Study Record Updates

Last Update Posted (Actual)

April 18, 2018

Last Update Submitted That Met QC Criteria

April 17, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 3/2013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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