Post-operative Blood Flow Measurements of the Oral Mucosa (LASCAM)

September 3, 2015 updated by: Dr. Vag Janos, Semmelweis University

Evaluation of Laser Speckle Contrast Imaging for Assessment of Oral Mucosal Blood Flow Following Periodontal Plastic Surgery: an Exploratory Observational Study

Our overall goal is to characterize the role of the microcirculation in healing oral mucosa after routinely applied surgery intervention in order to facilitate treatment. Using Laser Speckle Contrast Analysis (LASCA), which provides blood perfusion data, the investigators will have the possibility to detect functional alterations in gingival microcirculation in case of wound healing. After periodontal surgery, by means of the detection of microcirculation as a prognostic and diagnostic factor, the investigators can follow-up the healing procedure and obtain data so as to design e.g. the incision line that takes microvascular anatomy into account, thus result in better wound healing later on.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In today's periodontal plastic surgery numerous flap designs with various grafting alternatives (auto-allo- or xeno-grafts) are routinely applied. In order to achieve uneventful primary intention healing and to allow for graft integration resulting in successful clinical outcomes it is important to apply optimized surgical techniques with suitable graft materials to address various clinical demands (e.g. recession coverage, enlargement of keratinized tissues, correction of periimplant soft tissue deficiencies). Graft exposure during soft- and hard tissue augmentation might occur before any chance of graft vascularization due to wound healing disturbances and lack of primary intention healing. The reasons of flap failure could be compromised flap circulation, which can be avoided by proper flap design, tension free flap advancement. The role of flap design on the gingival blood flow was investigated after surgery and found that the simplified papilla preservation flap resulted in faster recovery of the blood flow than the modified Widman flap surgery. In order to minimize trauma on surrounding tissues (i.e. flap) it is recommendable to use the least invasive method for flap preparation, which may also protect the underlining graft tissue and support quick vascularization. These guidelines led to develop a minimal invasive flap design for root coverage surgery, namely supraperiosteal envelope Tunnel technique, which was later modified by Azzi et al. to coronally advance the mucogingival complex in order to cover the inserted graft. Later it was further modified by introducing microsurgical approach. The question still remains to be answered how the Tunnelling technique can influence microcirculation of the healing gingiva and how the underlying graft tissue affects the overlying mucosal flap.

Recently a new non-invasive, two dimensional method, namely the laser speckle contrast analysis (LASCA) has been introduced to evaluate microcirculation of tissue. Clinical pilot studies are suggesting that this technique may be useful tool for assessing the proper circulation during surgical intervention and evaluating wound healing in the skin in human. This new method may let us monitor the entire surgical area real-time before and during the healing period.

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

20 years to 50 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

Inclusion Criteria:

  • Having thin gingival biotype.
  • Clinical diagnosis of multiple gingival recession
  • Good general health

Exclusion Criteria:

  • pregnancy,
  • smoking,
  • general diseases,
  • take any antibiotics, antiinflammatory drugs, systemic steroids, biphosphonates, or any other medicines possibly influencing mucosal wound healing or any other products 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 before and after root coverage surgery. In this group the roots are covered by a combination of modified coronally advanced flap and xenograft 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:
  • LASCA, Perimed PSI
Device: wound fluid measurement
Wound fluid at the gingival sulcus was volumetrically measured by Periotron 8000 instrument using filter strip
Other Names:
  • Periotron
CTG
Laser speckle contrast imaging of the oral mucosa and wound fluid measurement before and after root coverage surgery. In this group the roots are covered by a combination of modified coronally advanced flap and subepithelial connective tissue graft (CTG), which was 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:
  • LASCA, Perimed PSI
Device: wound fluid measurement
Wound fluid at the gingival sulcus was volumetrically measured by Periotron 8000 instrument using filter strip
Other Names:
  • Periotron

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
The blood flow changes were measured by Laser Speckle Contrast Analyzer (LASCA) before and after root coverage surgery (modified coronally advanced technique). The scale was an arbitrary unit (0-3000 LSPU) and the relative changes to the pre-operative measurement were calculated. Postoperative follow-up time-points were: 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 17, 30, 60, 90, 120, 150, 180 days. The surgery was done with application of two different grafts (Mucograft-xenograft and connective tissue graft-autologous). The differences in postoperative blood flow changes were compared between the two graft-groups.
6 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative wound fluid changes of the oral mucosa
Time Frame: 6 months after surgery
The wound fluid changes were measured by Periotron 8000 instrument. Using a filter strip to withdraw the fluid around the wound. The filter strip was then inserted into the Periotron machine to score the volume on the paper. The scores were in a range of 0-200 (arbitrary unit). Postoperative follow-up time-points were: 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 17, 30, 60, 90, 120, 150, 180 days. The surgery was done with application of two different grafts (Mucograft-xenograft and connective tissue graft-autologous). The differences in postoperative wound fluid changes were compared between the two graft-groups.
6 months 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, 2014

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

August 25, 2015

First Submitted That Met QC Criteria

September 3, 2015

First Posted (Estimate)

September 4, 2015

Study Record Updates

Last Update Posted (Estimate)

September 4, 2015

Last Update Submitted That Met QC Criteria

September 3, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1/2013

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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