Patient Outcomes and Gingival Blood Flow Using Laser Doppler Flowmetry Following the Use of Episil on Free Gingival Graft Donor Sites

The University of Texas System (UT)

Status: Completed

Conditions: Pain From Free Gingival Graft

Treatments: Device: PeriAcryl90 wound dressing; Device: episil wound dressing

Study type: Interventional

Funder types: Other

Identifiers

NCT03350724

HSC-DB-15-0658

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

episil wound dressing

Experimental group

Description:

Episil is a wound dressing material intended for the management of pain and relief of pain by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies. episil is an oromucosal liquid that transforms in situ to a bioadhesive oromucosal gel by uptake of small amounts of aqueous fluid.

Treatment:

Device: episil wound dressing

PeriAcryl90 wound dressing

Active Comparator group

Description:

PeriAcryl90 is a cyanoacrylate wound dressing.

Treatment:

Device: PeriAcryl90 wound dressing