N/A N=34 Randomized Treatment

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

Bottom Line

View on ClinicalTrials.gov: NCT03350724 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2018

Primary outcome: Primary: 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

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: episil wound dressing (Device); PeriAcryl90 wound dressing (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: The University of Texas Health Science Center, Houston
Primary completion: May 2017

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 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 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 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 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 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 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 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
PRIMARY Postoperative Pain as Assessed by the Number of Analgesic Pills Taken Each Day	0; 0	0.357
PRIMARY Postoperative Pain as Assessed by the Number of Analgesic Pills Taken Each Day	0; 0	0.357
PRIMARY Postoperative Pain as Assessed by the Number of Analgesic Pills Taken Each Day	0; 0	0.357
PRIMARY Postoperative Pain as Assessed by the Number of Analgesic Pills Taken Each Day	0; 0	0.357
PRIMARY Postoperative Pain as Assessed by the Number of Analgesic Pills Taken Each Day	0; 0	0.357
PRIMARY Postoperative Pain as Assessed by the Number of Analgesic Pills Taken Each Day	0; 0	0.357
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 Gingival Blood Flow as Measured Laser Doppler Flowmetry (LDF)	151.2; 85.3	0.375
SECONDARY Gingival Blood Flow as Measured Laser Doppler Flowmetry (LDF)	151.2; 85.3	0.375
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	—
SECONDARY Number of Participants With Re-epithelialization of the FGG Donor Site as Indicated by a Non-invasive Peroxide Test	6; 5	—
SECONDARY Number of Participants With Re-epithelialization of the FGG Donor Site as Indicated by a Non-invasive Peroxide Test	6; 5	—
SECONDARY Number of Participants With Re-epithelialization of the FGG Donor Site as Indicated by a Non-invasive Peroxide Test	6; 5	—

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.

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

View full record on ClinicalTrials.gov →

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.