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

Randomized Controlled Clinical Trial Pilot Study: Patient Outcomes and Gingival Blood Flow Using Laser Doppler Flowmetry Following the Use of Episil on Free Gingival Graft Donor Sites

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.

Study Overview

• Status: Completed
• Conditions: Pain From Free Gingival Graft
• Intervention / Treatment: Device: episil wound dressing; Device: PeriAcryl90 wound dressing

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.
Active Comparator: PeriAcryl90 wound dressing; PeriAcryl90 is a cyanoacrylate wound dressing.	Device: PeriAcryl90 wound dressing; PeriAcryl90 is a cyanoacrylate wound dressing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Pain as Assessed by Number of Participants With a Score of 0-3 (no to Minimal Pain) on a Visual Analog Scale	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.	1 day postoperatively
Postoperative Pain as Assessed by Number of Participants With a Score of 0-3 (no to Minimal Pain) on a Visual Analog Scale	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.	2 days postoperatively
Postoperative Pain as Assessed by Number of Participants With a Score of 0-3 (no to Minimal Pain) on a Visual Analog Scale	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.	3 days postoperatively
Postoperative Pain as Assessed by Number of Participants With a Score of 0-3 (no to Minimal Pain) on a Visual Analog Scale	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.	5 days postoperatively
Postoperative Pain as Assessed by Number of Participants With a Score of 0-3 (no to Minimal Pain) on a Visual Analog Scale	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.	7 days postoperatively
Postoperative Pain as Assessed by Number of Participants With a Score of 0-3 (no to Minimal Pain) on a Visual Analog Scale	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.	10 days postoperatively
Postoperative Pain as Assessed by Number of Participants With a Score of 0-3 (no to Minimal Pain) on a Visual Analog Scale	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.	14 days postoperatively
Postoperative Pain as Assessed by Number of Participants With a Score of 0-3 (no to Minimal Pain) on a Visual Analog Scale	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.	21 days postoperatively
Postoperative Pain as Assessed by the Number of Analgesic Pills Taken Each Day	Postoperative pain will be determined by the subjects recording the number of analgesic pills (Ibuprofen 600mg tablets) taken each day.	1 day postoperatively
Postoperative Pain as Assessed by the Number of Analgesic Pills Taken Each Day	Postoperative pain will be determined by the subjects recording the number of analgesic pills (Ibuprofen 600mg tablets) taken each day.	2 days postoperatively
Postoperative Pain as Assessed by the Number of Analgesic Pills Taken Each Day	Postoperative pain will be determined by the subjects recording the number of analgesic pills (Ibuprofen 600mg tablets) taken each day.	3 days postoperatively
Postoperative Pain as Assessed by the Number of Analgesic Pills Taken Each Day	Postoperative pain will be determined by the subjects recording the number of analgesic pills (Ibuprofen 600mg tablets) taken each day.	5 days postoperatively
Postoperative Pain as Assessed by the Number of Analgesic Pills Taken Each Day	Postoperative pain will be determined by the subjects recording the number of analgesic pills (Ibuprofen 600mg tablets) taken each day.	7 days postoperatively
Postoperative Pain as Assessed by the Number of Analgesic Pills Taken Each Day	Postoperative pain will be determined by the subjects recording the number of analgesic pills (Ibuprofen 600mg tablets) taken each day.	10 days postoperatively
Postoperative Pain as Assessed by the Number of Analgesic Pills Taken Each Day	Postoperative pain will be determined by the subjects recording the number of analgesic pills (Ibuprofen 600mg tablets) taken each day.	14 days postoperatively
Postoperative Pain as Assessed by the Number of Analgesic Pills Taken Each Day	Postoperative pain will be determined by the subjects recording the number of analgesic pills taken each day.	21 days postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gingival Blood Flow as Measured Laser Doppler Flometry (LDF)	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.	baseline (on the day of surgery before surgery)
Gingival Blood Flow as Measured Laser Doppler Flowmetry (LDF)	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.	3 days postoperatively
Gingival Blood Flow as Measured Laser Doppler Flowmetry (LDF)	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.	7 days postoperatively
Gingival Blood Flow as Measured Laser Doppler Flowmetry (LDF)	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.	14 days postoperatively
Gingival Blood Flow as Measured Laser Doppler Flowmetry (LDF)	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.	21 days postoperatively
Number of Participants With Re-epithelialization of the FGG Donor Site as Indicated by a Non-invasive Peroxide Test	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).	3 days postoperatively
Number of Participants With Re-epithelialization of the FGG Donor Site as Indicated by a Non-invasive Peroxide Test	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).	7 days postoperatively
Number of Participants With Re-epithelialization of the FGG Donor Site as Indicated by a Non-invasive Peroxide Test	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).	14 days postoperatively
Number of Participants With Re-epithelialization of the FGG Donor Site as Indicated by a Non-invasive Peroxide Test	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).	21 days postoperatively

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Jennifer D James, DMD, MS, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2015
• Primary Completion (Actual): May 19, 2017
• Study Completion (Actual): May 19, 2017

Study Registration Dates

• First Submitted: November 17, 2017
• First Submitted That Met QC Criteria: November 17, 2017
• First Posted (Actual): November 22, 2017

Study Record Updates

• Last Update Posted (Actual): April 17, 2018
• Last Update Submitted That Met QC Criteria: March 19, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: HSC-DB-15-0658

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No