Clinical trial NCT02975024: Blood Flow Analysis of the Human Mucosa After Vestibuloplasty Procedures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mucogingival Defect
Keywords: mandibular vestibuloplasty
wound healing
microcirculation
Laser Speckle Contrast Imager
Mucograft
strip gingival graft
Lead sponsor: Semmelweis University
Sponsor class: OTHER
Collaborators: name: Hungarian Scientific Research Fund
First posted: 2016-11-29
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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)

Primary outcomes:
measure: Postoperative blood flow changes of the oral mucosa
timeFrame: 6 months after surgery
Secondary outcomes:
measure: Wound fluid volume measurement
timeFrame: 14 days after surgery
measure: Evaluation of the periodontal parameters at teeth at the surgical site: a composite outcome measure consisting of multiple measures.
timeFrame: Pre- and six month postoperative
measure: Quantitative determination of Vascular Endothelial Growth Factor (VEGF) of the wound fluid
timeFrame: 4 days after surgery
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Janos Vag
Study officials:
affiliation: Semmelweis University, Dept. of Conservative Dentistry
name: Janos Vag
role: PRINCIPAL_INVESTIGATOR
References: