Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03350724
Recruitment Status : Completed
First Posted : November 22, 2017
Results First Posted : March 20, 2018
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
Jennifer James, The University of Texas Health Science Center, Houston

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pain From Free Gingival Graft
Interventions Device: episil wound dressing
Device: PeriAcryl90 wound dressing
Enrollment 34
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Episil Wound Dressing PeriAcryl90 Wound Dressing
Hide Arm/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. PeriAcryl90 is a cyanoacrylate wound dressing.
Period Title: Overall Study
Started 17 17
Completed 17 17
Not Completed 0 0
Arm/Group Title Episil Wound Dressing PeriAcryl90 Wound Dressing Total
Hide Arm/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. PeriAcryl90 is a cyanoacrylate wound dressing. Total of all reporting groups
Overall Number of Baseline Participants 17 17 34
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants 17 participants 34 participants
46.5  (17.2) 47.1  (15.5) 46.8  (16.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 17 participants 34 participants
Female
9
  52.9%
13
  76.5%
22
  64.7%
Male
8
  47.1%
4
  23.5%
12
  35.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 17 participants 34 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
  11.8%
0
   0.0%
2
   5.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   5.9%
1
   5.9%
2
   5.9%
White
14
  82.4%
16
  94.1%
30
  88.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 17 participants 17 participants 34 participants
17
 100.0%
17
 100.0%
34
 100.0%
1.Primary Outcome
Title Postoperative Pain as Assessed by Number of Participants With a Score of 0-3 (no to Minimal Pain) on a Visual Analog Scale
Hide Description 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.
Time Frame 1 day postoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Episil Wound Dressing PeriAcryl90 Wound Dressing
Hide Arm/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.
PeriAcryl90 is a cyanoacrylate wound dressing.
Overall Number of Participants Analyzed 17 17
Measure Type: Count of Participants
Unit of Measure: Participants
12
  70.6%
6
  35.3%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Episil Wound Dressing, PeriAcryl90 Wound Dressing
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.039
Comments Unadjusted p-value
Method Z-Test for Two Population Proportions
Comments Unadjusted p-value
2.Primary Outcome
Title Postoperative Pain as Assessed by Number of Participants With a Score of 0-3 (no to Minimal Pain) on a Visual Analog Scale
Hide Description 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.
Time Frame 2 days postoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Episil Wound Dressing PeriAcryl90 Wound Dressing
Hide Arm/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.
PeriAcryl90 is a cyanoacrylate wound dressing.
Overall Number of Participants Analyzed 17 17
Measure Type: Count of Participants
Unit of Measure: Participants
13
  76.5%
7
  41.2%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Episil Wound Dressing, PeriAcryl90 Wound Dressing
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.037
Comments Unadjusted p-value
Method Z-Test for Two Population Proportions
Comments Unadjusted p-value
3.Primary Outcome
Title Postoperative Pain as Assessed by Number of Participants With a Score of 0-3 (no to Minimal Pain) on a Visual Analog Scale
Hide Description 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.
Time Frame 3 days postoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Episil Wound Dressing PeriAcryl90 Wound Dressing
Hide Arm/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.
PeriAcryl90 is a cyanoacrylate wound dressing.
Overall Number of Participants Analyzed 17 17
Measure Type: Count of Participants
Unit of Measure: Participants
14
  82.4%
8
  47.1%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Episil Wound Dressing, PeriAcryl90 Wound Dressing
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.032
Comments [Not Specified]
Method Z-Test for Two Population Proportions
Comments [Not Specified]
4.Primary Outcome
Title Postoperative Pain as Assessed by Number of Participants With a Score of 0-3 (no to Minimal Pain) on a Visual Analog Scale
Hide Description 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.
Time Frame 5 days postoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Episil Wound Dressing PeriAcryl90 Wound Dressing
Hide Arm/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.
PeriAcryl90 is a cyanoacrylate wound dressing.
Overall Number of Participants Analyzed 17 17
Measure Type: Count of Participants
Unit of Measure: Participants
11
  64.7%
8
  47.1%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Episil Wound Dressing, PeriAcryl90 Wound Dressing
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.171
Comments Unadjusted p-value
Method Z-Test for Two Population Proportions
Comments Unadjusted p-value
5.Primary Outcome
Title Postoperative Pain as Assessed by Number of Participants With a Score of 0-3 (no to Minimal Pain) on a Visual Analog Scale
Hide Description 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.
Time Frame 7 days postoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Episil Wound Dressing PeriAcryl90 Wound Dressing
Hide Arm/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.
PeriAcryl90 is a cyanoacrylate wound dressing.
Overall Number of Participants Analyzed 17 17
Measure Type: Count of Participants
Unit of Measure: Participants
11
  64.7%
9
  52.9%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Episil Wound Dressing, PeriAcryl90 Wound Dressing
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.484
Comments Unadjusted p-value
Method Z-Test for Two Population Proportions
Comments Unadjusted p-value
6.Primary Outcome
Title Postoperative Pain as Assessed by Number of Participants With a Score of 0-3 (no to Minimal Pain) on a Visual Analog Scale
Hide Description 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.
Time Frame 10 days postoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Episil Wound Dressing PeriAcryl90 Wound Dressing
Hide Arm/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.
PeriAcryl90 is a cyanoacrylate wound dressing.
Overall Number of Participants Analyzed 17 17
Measure Type: Count of Participants
Unit of Measure: Participants
13
  76.5%
15
  88.2%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Episil Wound Dressing, PeriAcryl90 Wound Dressing
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.368
Comments Unadjusted p-value
Method Z-Test for Two Population Proportions
Comments Unadjusted p-value
7.Primary Outcome
Title Postoperative Pain as Assessed by Number of Participants With a Score of 0-3 (no to Minimal Pain) on a Visual Analog Scale
Hide Description 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.
Time Frame 14 days postoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Episil Wound Dressing PeriAcryl90 Wound Dressing
Hide Arm/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.
PeriAcryl90 is a cyanoacrylate wound dressing.
Overall Number of Participants Analyzed 17 17
Measure Type: Count of Participants
Unit of Measure: Participants
17
 100.0%
16
  94.1%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Episil Wound Dressing, PeriAcryl90 Wound Dressing
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.308
Comments Unadjusted p-value
Method Z-Test for Two Population Proportions
Comments Unadjusted p-value
8.Primary Outcome
Title Postoperative Pain as Assessed by Number of Participants With a Score of 0-3 (no to Minimal Pain) on a Visual Analog Scale
Hide Description 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.
Time Frame 21 days postoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Episil Wound Dressing PeriAcryl90 Wound Dressing
Hide Arm/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.
PeriAcryl90 is a cyanoacrylate wound dressing.
Overall Number of Participants Analyzed 17 17
Measure Type: Count of Participants
Unit of Measure: Participants
17
 100.0%
17
 100.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Episil Wound Dressing, PeriAcryl90 Wound Dressing
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.999
Comments Unadjusted p-value
Method Z-Test for Two Population Proportions
Comments Unadjusted p-value
9.Primary Outcome
Title Postoperative Pain as Assessed by the Number of Analgesic Pills Taken Each Day
Hide Description Postoperative pain will be determined by the subjects recording the number of analgesic pills (Ibuprofen 600mg tablets) taken each day.
Time Frame 1 day postoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Episil Wound Dressing PeriAcryl90 Wound Dressing
Hide Arm/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.
PeriAcryl90 is a cyanoacrylate wound dressing.
Overall Number of Participants Analyzed 17 17
Median (Inter-Quartile Range)
Unit of Measure: number of Ibuprofen 600mg tablets
2
(1 to 3)
3
(2 to 4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Episil Wound Dressing, PeriAcryl90 Wound Dressing
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.015
Comments Unadjusted p-value
Method Wilcoxon (Mann-Whitney)
Comments Unadjusted p-value
10.Primary Outcome
Title Postoperative Pain as Assessed by the Number of Analgesic Pills Taken Each Day
Hide Description Postoperative pain will be determined by the subjects recording the number of analgesic pills (Ibuprofen 600mg tablets) taken each day.
Time Frame 2 days postoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Episil Wound Dressing PeriAcryl90 Wound Dressing
Hide Arm/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.
PeriAcryl90 is a cyanoacrylate wound dressing.
Overall Number of Participants Analyzed 17 17
Median (Inter-Quartile Range)
Unit of Measure: number of Ibuprofen 600mg tablets
2
(1 to 3)
3
(2 to 4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Episil Wound Dressing, PeriAcryl90 Wound Dressing
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.021
Comments Unadjusted p-value
Method Wilcoxon (Mann-Whitney)
Comments Unadjusted p-value
11.Primary Outcome
Title Postoperative Pain as Assessed by the Number of Analgesic Pills Taken Each Day
Hide Description Postoperative pain will be determined by the subjects recording the number of analgesic pills (Ibuprofen 600mg tablets) taken each day.
Time Frame 3 days postoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Episil Wound Dressing PeriAcryl90 Wound Dressing
Hide Arm/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.
PeriAcryl90 is a cyanoacrylate wound dressing.
Overall Number of Participants Analyzed 17 17
Median (Inter-Quartile Range)
Unit of Measure: number of Ibuprofen 600mg tablets
2
(1 to 2)
2
(2 to 4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Episil Wound Dressing, PeriAcryl90 Wound Dressing
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.035
Comments Unadjusted p-value
Method Wilcoxon (Mann-Whitney)
Comments Unadjusted p-value
12.Primary Outcome
Title Postoperative Pain as Assessed by the Number of Analgesic Pills Taken Each Day
Hide Description Postoperative pain will be determined by the subjects recording the number of analgesic pills (Ibuprofen 600mg tablets) taken each day.
Time Frame 5 days postoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Episil Wound Dressing PeriAcryl90 Wound Dressing
Hide Arm/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.
PeriAcryl90 is a cyanoacrylate wound dressing.
Overall Number of Participants Analyzed 17 17
Median (Inter-Quartile Range)
Unit of Measure: number of Ibuprofen 600mg tablets
2
(1 to 3)
2
(1 to 3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Episil Wound Dressing, PeriAcryl90 Wound Dressing
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.444
Comments Unadjusted p-value
Method Wilcoxon (Mann-Whitney)
Comments Unadjusted p-value
13.Primary Outcome
Title Postoperative Pain as Assessed by the Number of Analgesic Pills Taken Each Day
Hide Description Postoperative pain will be determined by the subjects recording the number of analgesic pills (Ibuprofen 600mg tablets) taken each day.
Time Frame 7 days postoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Episil Wound Dressing PeriAcryl90 Wound Dressing
Hide Arm/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.
PeriAcryl90 is a cyanoacrylate wound dressing.
Overall Number of Participants Analyzed 17 17
Median (Inter-Quartile Range)
Unit of Measure: number of Ibuprofen 600mg tablets
2
(1 to 3)
2
(1 to 3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Episil Wound Dressing, PeriAcryl90 Wound Dressing
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.765
Comments Unadjusted p-value
Method Wilcoxon (Mann-Whitney)
Comments Unadjusted p-value
14.Primary Outcome
Title Postoperative Pain as Assessed by the Number of Analgesic Pills Taken Each Day
Hide Description Postoperative pain will be determined by the subjects recording the number of analgesic pills (Ibuprofen 600mg tablets) taken each day.
Time Frame 10 days postoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Episil Wound Dressing PeriAcryl90 Wound Dressing
Hide Arm/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.
PeriAcryl90 is a cyanoacrylate wound dressing.
Overall Number of Participants Analyzed 17 17
Median (Inter-Quartile Range)
Unit of Measure: number of Ibuprofen 600mg tablets
1
(0 to 2)
1
(0 to 2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Episil Wound Dressing, PeriAcryl90 Wound Dressing
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.941
Comments Unadjusted p-value
Method Wilcoxon (Mann-Whitney)
Comments Unadjusted p-value
15.Primary Outcome
Title Postoperative Pain as Assessed by the Number of Analgesic Pills Taken Each Day
Hide Description Postoperative pain will be determined by the subjects recording the number of analgesic pills (Ibuprofen 600mg tablets) taken each day.
Time Frame 14 days postoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Episil Wound Dressing PeriAcryl90 Wound Dressing
Hide Arm/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.
PeriAcryl90 is a cyanoacrylate wound dressing.
Overall Number of Participants Analyzed 17 17
Median (Inter-Quartile Range)
Unit of Measure: number of Ibuprofen 600mg tablets
0
(0 to 0)
1
(0 to 1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Episil Wound Dressing, PeriAcryl90 Wound Dressing
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.421
Comments Unadjusted p-value
Method Wilcoxon (Mann-Whitney)
Comments Unadjusted p-value
16.Primary Outcome
Title Postoperative Pain as Assessed by the Number of Analgesic Pills Taken Each Day
Hide Description Postoperative pain will be determined by the subjects recording the number of analgesic pills taken each day.
Time Frame 21 days postoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Episil Wound Dressing PeriAcryl90 Wound Dressing
Hide Arm/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.
PeriAcryl90 is a cyanoacrylate wound dressing.
Overall Number of Participants Analyzed 17 17
Median (Inter-Quartile Range)
Unit of Measure: number of Ibuprofen 600mg tablets
0
(0 to 0)
0
(0 to 0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Episil Wound Dressing, PeriAcryl90 Wound Dressing
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.357
Comments Unadjusted p-value
Method Wilcoxon (Mann-Whitney)
Comments Unadjusted p-value
17.Secondary Outcome
Title Gingival Blood Flow as Measured Laser Doppler Flometry (LDF)
Hide Description 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.
Time Frame baseline (on the day of surgery before surgery)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Episil Wound Dressing PeriAcryl90 Wound Dressing
Hide Arm/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.
PeriAcryl90 is a cyanoacrylate wound dressing.
Overall Number of Participants Analyzed 17 17
Mean (Standard Deviation)
Unit of Measure: mL/100g/min
-34.7  (126.7) 5.3  (36.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Episil Wound Dressing, PeriAcryl90 Wound Dressing
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.22
Comments Unadjusted p-value
Method Paired t-Test
Comments Unadjusted p-value
18.Secondary Outcome
Title Gingival Blood Flow as Measured Laser Doppler Flowmetry (LDF)
Hide Description 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.
Time Frame 3 days postoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
One patient was not able to have Day 3 laser Doppler flowmetry (LDF) readings because of a death in the family, and this patient had to travel out of town for several days.
Arm/Group Title Episil Wound Dressing PeriAcryl90 Wound Dressing
Hide Arm/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.
PeriAcryl90 is a cyanoacrylate wound dressing.
Overall Number of Participants Analyzed 16 16
Mean (Standard Deviation)
Unit of Measure: mL/100g/min
42.5  (132.1) 50.0  (152.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Episil Wound Dressing, PeriAcryl90 Wound Dressing
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.882
Comments Unadjusted p-value
Method Paired t-Test
Comments Unadjusted p-value
19.Secondary Outcome
Title Gingival Blood Flow as Measured Laser Doppler Flowmetry (LDF)
Hide Description 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.
Time Frame 7 days postoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Episil Wound Dressing PeriAcryl90 Wound Dressing
Hide Arm/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.
PeriAcryl90 is a cyanoacrylate wound dressing.
Overall Number of Participants Analyzed 17 17
Mean (Standard Deviation)
Unit of Measure: mL/100g/min
203.9  (219.8) 169.0  (197.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Episil Wound Dressing, PeriAcryl90 Wound Dressing
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.64
Comments Unadjusted p-value
Method Paired t-Test
Comments Unadjusted p-value
20.Secondary Outcome
Title Gingival Blood Flow as Measured Laser Doppler Flowmetry (LDF)
Hide Description 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.
Time Frame 14 days postoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Episil Wound Dressing PeriAcryl90 Wound Dressing
Hide Arm/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.
PeriAcryl90 is a cyanoacrylate wound dressing.
Overall Number of Participants Analyzed 17 17
Mean (Standard Deviation)
Unit of Measure: mL/100g/min
266.3  (242.9) 262.8  (248.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Episil Wound Dressing, PeriAcryl90 Wound Dressing
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.967
Comments Unadjusted p-value
Method Paired t-Test
Comments Unadjusted p-value
21.Secondary Outcome
Title Gingival Blood Flow as Measured Laser Doppler Flowmetry (LDF)
Hide Description 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.
Time Frame 21 days postoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Episil Wound Dressing PeriAcryl90 Wound Dressing
Hide Arm/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.
PeriAcryl90 is a cyanoacrylate wound dressing.
Overall Number of Participants Analyzed 17 17
Mean (Standard Deviation)
Unit of Measure: mL/100g/min
151.2  (227.1) 85.3  (184.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Episil Wound Dressing, PeriAcryl90 Wound Dressing
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.375
Comments Unadjusted p-value
Method Paired t-Test
Comments Unadjusted p-value
22.Secondary Outcome
Title Number of Participants With Re-epithelialization of the FGG Donor Site as Indicated by a Non-invasive Peroxide Test
Hide Description 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).
Time Frame 3 days postoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Episil Wound Dressing PeriAcryl90 Wound Dressing
Hide Arm/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.
PeriAcryl90 is a cyanoacrylate wound dressing.
Overall Number of Participants Analyzed 17 17
Measure Type: Count of Participants
Unit of Measure: Participants
1
   5.9%
0
   0.0%
23.Secondary Outcome
Title Number of Participants With Re-epithelialization of the FGG Donor Site as Indicated by a Non-invasive Peroxide Test
Hide Description 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).
Time Frame 7 days postoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Episil Wound Dressing PeriAcryl90 Wound Dressing
Hide Arm/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.
PeriAcryl90 is a cyanoacrylate wound dressing.
Overall Number of Participants Analyzed 17 17
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
24.Secondary Outcome
Title Number of Participants With Re-epithelialization of the FGG Donor Site as Indicated by a Non-invasive Peroxide Test
Hide Description 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).
Time Frame 14 days postoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Episil Wound Dressing PeriAcryl90 Wound Dressing
Hide Arm/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.
PeriAcryl90 is a cyanoacrylate wound dressing.
Overall Number of Participants Analyzed 17 17
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
25.Secondary Outcome
Title Number of Participants With Re-epithelialization of the FGG Donor Site as Indicated by a Non-invasive Peroxide Test
Hide Description 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).
Time Frame 21 days postoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Episil Wound Dressing PeriAcryl90 Wound Dressing
Hide Arm/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.
PeriAcryl90 is a cyanoacrylate wound dressing.
Overall Number of Participants Analyzed 17 17
Measure Type: Count of Participants
Unit of Measure: Participants
6
  35.3%
5
  29.4%
Time Frame 21 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Episil Wound Dressing PeriAcryl90 Wound Dressing
Hide Arm/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. PeriAcryl90 is a cyanoacrylate wound dressing.
All-Cause Mortality
Episil Wound Dressing PeriAcryl90 Wound Dressing
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/17 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Episil Wound Dressing PeriAcryl90 Wound Dressing
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/17 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Episil Wound Dressing PeriAcryl90 Wound Dressing
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/17 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Jennifer James, DMD, MS
Organization: The University of Texas Health Science Center at Houston
Phone: 713-486-4383
Responsible Party: Jennifer James, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT03350724     History of Changes
Other Study ID Numbers: HSC-DB-15-0658
First Submitted: November 17, 2017
First Posted: November 22, 2017
Results First Submitted: February 19, 2018
Results First Posted: March 20, 2018
Last Update Posted: April 17, 2018