Mucogingival Defect Clinical Trial
| Verified date | April 2018 |
| Source | Semmelweis University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 8 |
| Est. completion date | December 2017 |
| Est. primary completion date | December 2017 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 45 Years |
| Eligibility |
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) |
| Country | Name | City | State |
|---|---|---|---|
| Hungary | Janos Vag | Budapest |
| Lead Sponsor | Collaborator |
|---|---|
| Semmelweis University | Hungarian Scientific Research Fund |
Hungary,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 | |
| Secondary | 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 | |
| Secondary | 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 |