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

NCT ID: NCT03350724

Last Updated: 2018-04-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-29

Study Completion Date

2017-05-19

Brief Summary

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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.

Detailed Description

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Conditions

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Pain From Free Gingival Graft

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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episil wound dressing

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.

Group Type EXPERIMENTAL

episil wound dressing

Intervention Type DEVICE

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.

PeriAcryl90 wound dressing

PeriAcryl90 is a cyanoacrylate wound dressing.

Group Type ACTIVE_COMPARATOR

PeriAcryl90 wound dressing

Intervention Type DEVICE

PeriAcryl90 is a cyanoacrylate wound dressing.

Interventions

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episil wound dressing

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.

Intervention Type DEVICE

PeriAcryl90 wound dressing

PeriAcryl90 is a cyanoacrylate wound dressing.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Jennifer James

Clinical Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jennifer D James, DMD, MS

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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HSC-DB-15-0658

Identifier Type: -

Identifier Source: org_study_id

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