Blood Flow Analysis of the Human Mucosa After Vestibuloplasty Procedures
- Conditions
- Mucogingival Defect
- Interventions
- Device: laser speckle contrast imaging of the oral mucosaDevice: wound fluid measurementDevice: quantitative determination of VEGF
- Registration Number
- NCT02975024
- Lead Sponsor
- Semmelweis University
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8
• clinical diagnosis of inadequate width of keratinized gingiva at the mandibular front region
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description strip gingival graft + Mucograft laser speckle contrast imaging of the oral mucosa 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. strip gingival graft + Mucograft quantitative determination of VEGF 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. Mucograft laser speckle contrast imaging of the oral mucosa 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). Mucograft wound fluid measurement 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). Mucograft quantitative determination of VEGF 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). strip gingival graft + Mucograft wound fluid measurement 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.
- Primary Outcome Measures
Name Time Method Postoperative blood flow changes of the oral mucosa 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 Outcome Measures
Name Time Method Wound fluid volume measurement 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.
Evaluation of the periodontal parameters at teeth at the surgical site: a composite outcome measure consisting of multiple measures. 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.
Quantitative determination of Vascular Endothelial Growth Factor (VEGF) of the wound fluid 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.
Trial Locations
- Locations (1)
Janos Vag
🇭🇺Budapest, Hungary