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Completed

NCT Number: NCT02975024

Blood Flow Analysis of the Human Mucosa After Vestibuloplasty Procedures

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.

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Key information

Conditions

Mucogingival Defect

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Janos Vag

Budapest, 1088, Hungary

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

laser speckle contrast imaging of the oral mucosa

Device

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

Other names: LSCI Perimed PSI

wound fluid measurement

Device

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

Other names: Periotron 8010

quantitative determination of VEGF

Device

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Semmelweis University

Other

Collaborators

  • Hungarian Scientific Research Fund

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 29, 2016
Registry last updated
Apr 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.