N/A
Completed N=34
Patient Outcomes and Gingival Blood Flow Using Laser Doppler Flowmetry Following the Use of Episil on Free Gingival Graft Donor Sites
Pain From Free Gingival Graft
Source: ClinicalTrials.gov NCT03350724 ↗
Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Mar 2018
Primary outcomePrimary: Postoperative Pain as Assessed by Number of Participants With a Score of 0-3 (no to Minimal Pain) on a Visual Analog Scale — 12; 6 Participants — p=0.039
Summary
The hypothesis for the present study is that patient-based outcomes and gingival blood flow will be more favorable for the free gingival graft (FGG) donor sites being covered by the test wound dressing material episil compared to the control dressing.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Postoperative Pain as Assessed by Number of Participants With a Score of 0-3 (no to Minimal Pain) on a Visual Analog Scale |
17; 17 | 0.999 |
| PRIMARY Postoperative Pain as Assessed by the Number of Analgesic Pills Taken Each Day |
0; 0 | 0.357 |
| SECONDARY Gingival Blood Flow as Measured Laser Doppler Flometry (LDF) |
-34.7; 5.3 | 0.22 |
| SECONDARY Gingival Blood Flow as Measured Laser Doppler Flowmetry (LDF) |
151.2; 85.3 | 0.375 |
| SECONDARY Number of Participants With Re-epithelialization of the FGG Donor Site as Indicated by a Non-invasive Peroxide Test |
6; 5 | — |
Eligibility Criteria
Inclusion Criteria
- patient of record at UTHealth School of Dentistry Houston Texas
- signed treatment plan for a FGG
- the ability to provide research informed consent
Exclusion Criteria
- any allergies to any of the ingredients in episil including allergies to peanuts, soy or peppermint oil
- smokers
- pregnant or breast feeding women
- inability or unwillingness to provide informed consent
Data sourced from ClinicalTrials.gov (NCT03350724). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.