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Blood Flow Analysis of the Human Mucosa After Vestibuloplasty Procedures

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02975024
Enrollment
8
Registered
2016-11-29
Start date
2016-11-30
Completion date
2017-12-31
Last updated
2018-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mucogingival Defect

Keywords

mandibular vestibuloplasty, wound healing, microcirculation, Laser Speckle Contrast Imager, Mucograft, strip gingival graft

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.

Interventions

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

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

DEVICEquantitative 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.

Sponsors

Hungarian Scientific Research Fund
CollaboratorUNKNOWN
Semmelweis University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

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)

Design outcomes

Primary

MeasureTime frameDescription
Postoperative blood flow changes of the oral mucosa6 months after surgeryBlood 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

MeasureTime frameDescription
Wound fluid volume measurement14 days after surgeryWound 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 postoperativePeriodontal 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 fluid4 days after surgeryWound 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.

Countries

Hungary

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026