Blood Flow Analysis of the Human Mucosa After Vestibuloplasty Procedures

Study Overview
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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

Intervention / Treatment
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* Device: laser speckle contrast imaging of the oral mucosa
* Device: wound fluid measurement
* Device: quantitative determination of VEGF


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Mucograft<br>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<br>* Non-invasive method to measure tissue blood perfusion applied for oral mucosa<br>* Other names: LSCI Perimed PSI;Device: wound fluid measurement<br>* Wound fluid at the wound margin is collected using filter strip and volumetrically measured by Periotron 8010 instrument.<br>* Other names: Periotron 8010;Device: quantitative determination of VEGF<br>* For the quantitative determination of VEGF in the fourth day wound fluid sample the Human VEGF Quantikine ELISA Kit will be used.<br>* Other names: Human VEGF Quantikine ELISA Kit;|
| strip gingival graft + Mucograft<br>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<br>* Non-invasive method to measure tissue blood perfusion applied for oral mucosa<br>* Other names: LSCI Perimed PSI;Device: wound fluid measurement<br>* Wound fluid at the wound margin is collected using filter strip and volumetrically measured by Periotron 8010 instrument.<br>* Other names: Periotron 8010;Device: quantitative determination of VEGF<br>* For the quantitative determination of VEGF in the fourth day wound fluid sample the Human VEGF Quantikine ELISA Kit will be used.<br>* Other names: Human VEGF Quantikine ELISA Kit;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative blood flow changes of the oral mucosa | 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 | 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. | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mandibular vestibuloplasty, wound healing, microcirculation, Laser Speckle Contrast Imager, Mucograft, strip gingival graft