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

Not Applicable

Completed

• Conditions: Pain From Free Gingival Graft
• Interventions: Device: PeriAcryl90 wound dressing; Device: episil wound dressing

• Registration Number: NCT03350724
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-29
• Primary Completion: 2017-05-19
• Study Completion: 2017-05-19
• Study First Submitted: 2017-11-17
• Study First Submitted QC: 2017-11-17
• Study First Posted: 2017-11-22
• Results First Submitted: 2018-02-19
• Results First Submitted QC: 2018-02-19
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-19
• Results First Posted: 2018-03-20
• Last Update Posted: 2018-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PeriAcryl90 wound dressing	PeriAcryl90 wound dressing	PeriAcryl90 is a cyanoacrylate wound dressing.
episil wound dressing	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.

Primary Outcome Measures

Name	Time	Method
Postoperative Pain as Assessed by the Number of Analgesic Pills Taken Each Day	21 days postoperatively	Postoperative pain will be determined by the subjects recording the number of analgesic pills taken each day.
Postoperative Pain as Assessed by Number of Participants With a Score of 0-3 (no to Minimal Pain) on a Visual Analog Scale	21 days postoperatively	Postoperative pain will be determined by the subjects recording their postoperative pain threshold using a Visual Analog Scale with scores from 1 to 10, with 1 indicating minimal pain and 10 indicating severe pain. If no pain is present, a score of 0 will be given. The levels of postoperative pain will be classified as none to minimum if the score is "0 to 3," moderate for "4 to 6," and severe for "7 to 10." None to minimal pain will mean little or no discomfort; moderate is any pain that bothers the subject and mildly affects normal function; and severe will be considered any pain that will not be tolerated and may even disrupt the subject's daily functions.

Secondary Outcome Measures

Name	Time	Method
Gingival Blood Flow as Measured Laser Doppler Flometry (LDF)	baseline (on the day of surgery before surgery)	The laser Doppler flowmetry (LDF) technique to measure the blood perfusion of the free gingival graft (FGG) donor site. The value reported is blood flow at the FGG donor site (operated site) minus blood flow at the contralateral side of the palate (non-operated site). Perfusion Units (PU) are reported, which is blood flow through a given volume or mass of tissue with the unit of measure mL/100g/min.
Number of Participants With Re-epithelialization of the FGG Donor Site as Indicated by a Non-invasive Peroxide Test	21 days postoperatively	The non-invasive peroxide test is based on the principle that if the epithelium is discontinuous, the H2O2 diffuses into the connective tissue; the enzyme catalase acts on H2O2 to release water and oxygen: this is clinically shown by the production of bubbles on the wound. 3% H2O2 will be applied to the FGG donor site with a syringe and the appearance of bubbles will be recorded as a dichotomous variable (yes/no).
Gingival Blood Flow as Measured Laser Doppler Flowmetry (LDF)	21 days postoperatively	The laser Doppler flowmetry (LDF) technique to measure the blood perfusion of the FGG donor site. The value reported is blood flow at the FGG donor site (operated site) minus blood flow at the contralateral side of the palate (non-operated site). Perfusion Units (PU) are reported, which is blood flow through a given volume or mass of tissue with the unit of measure mL/100g/min.

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States