Pain From Free Gingival Graft
Conditions
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.
Interventions
DEVICEepisil 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.
DEVICEPeriAcryl90 wound dressing
PeriAcryl90 is a cyanoacrylate wound dressing.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain as Assessed by Number of Participants With a Score of 0-3 (no to Minimal Pain) on a Visual Analog Scale | 1 day 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. |
| Postoperative Pain as Assessed by the Number of Analgesic Pills Taken Each Day | 1 day postoperatively | Postoperative pain will be determined by the subjects recording the number of analgesic pills (Ibuprofen 600mg tablets) taken each day. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Gingival Blood Flow as Measured Laser Doppler Flowmetry (LDF) | 3 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. |
| Number of Participants With Re-epithelialization of the FGG Donor Site as Indicated by a Non-invasive Peroxide Test | 3 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 17 |
| PeriAcryl90 Wound Dressing PeriAcryl90 is a cyanoacrylate wound dressing. | 17 |
| Total | 34 |
Baseline characteristics
| Characteristic | Episil Wound Dressing | Total | PeriAcryl90 Wound Dressing |
|---|---|---|---|
| Age, Continuous | 46.5 years STANDARD_DEVIATION 17.2 | 46.8 years STANDARD_DEVIATION 16.4 | 47.1 years STANDARD_DEVIATION 15.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 14 Participants | 30 Participants | 16 Participants |
| Region of Enrollment United States | 17 Participants | 34 Participants | 17 Participants |
| Sex: Female, Male Female | 9 Participants | 22 Participants | 13 Participants |
| Sex: Female, Male Male | 8 Participants | 12 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 17 |
| other Total, other adverse events | 0 / 17 | 0 / 17 |
| serious Total, serious adverse events | 0 / 17 | 0 / 17 |
Outcome results
Primary
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.
Time frame: 1 day postoperatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Episil Wound Dressing | Postoperative Pain as Assessed by Number of Participants With a Score of 0-3 (no to Minimal Pain) on a Visual Analog Scale | 12 Participants |
| PeriAcryl90 Wound Dressing | Postoperative Pain as Assessed by Number of Participants With a Score of 0-3 (no to Minimal Pain) on a Visual Analog Scale | 6 Participants |
p-value: 0.039Z-Test for Two Population Proportions
Primary
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.
Time frame: 21 days postoperatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Episil Wound Dressing | Postoperative Pain as Assessed by Number of Participants With a Score of 0-3 (no to Minimal Pain) on a Visual Analog Scale | 17 Participants |
| PeriAcryl90 Wound Dressing | Postoperative Pain as Assessed by Number of Participants With a Score of 0-3 (no to Minimal Pain) on a Visual Analog Scale | 17 Participants |
p-value: 0.999Z-Test for Two Population Proportions
Primary
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.
Time frame: 2 days postoperatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Episil Wound Dressing | Postoperative Pain as Assessed by Number of Participants With a Score of 0-3 (no to Minimal Pain) on a Visual Analog Scale | 13 Participants |
| PeriAcryl90 Wound Dressing | Postoperative Pain as Assessed by Number of Participants With a Score of 0-3 (no to Minimal Pain) on a Visual Analog Scale | 7 Participants |
p-value: 0.037Z-Test for Two Population Proportions
Primary
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.
Time frame: 3 days postoperatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Episil Wound Dressing | Postoperative Pain as Assessed by Number of Participants With a Score of 0-3 (no to Minimal Pain) on a Visual Analog Scale | 14 Participants |
| PeriAcryl90 Wound Dressing | Postoperative Pain as Assessed by Number of Participants With a Score of 0-3 (no to Minimal Pain) on a Visual Analog Scale | 8 Participants |
p-value: 0.032Z-Test for Two Population Proportions
Primary
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.
Time frame: 5 days postoperatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Episil Wound Dressing | Postoperative Pain as Assessed by Number of Participants With a Score of 0-3 (no to Minimal Pain) on a Visual Analog Scale | 11 Participants |
| PeriAcryl90 Wound Dressing | Postoperative Pain as Assessed by Number of Participants With a Score of 0-3 (no to Minimal Pain) on a Visual Analog Scale | 8 Participants |
p-value: 0.171Z-Test for Two Population Proportions
Primary
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.
Time frame: 7 days postoperatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Episil Wound Dressing | Postoperative Pain as Assessed by Number of Participants With a Score of 0-3 (no to Minimal Pain) on a Visual Analog Scale | 11 Participants |
| PeriAcryl90 Wound Dressing | Postoperative Pain as Assessed by Number of Participants With a Score of 0-3 (no to Minimal Pain) on a Visual Analog Scale | 9 Participants |
p-value: 0.484Z-Test for Two Population Proportions
Primary
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.
Time frame: 10 days postoperatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Episil Wound Dressing | Postoperative Pain as Assessed by Number of Participants With a Score of 0-3 (no to Minimal Pain) on a Visual Analog Scale | 13 Participants |
| PeriAcryl90 Wound Dressing | Postoperative Pain as Assessed by Number of Participants With a Score of 0-3 (no to Minimal Pain) on a Visual Analog Scale | 15 Participants |
p-value: 0.368Z-Test for Two Population Proportions
Primary
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.
Time frame: 14 days postoperatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Episil Wound Dressing | Postoperative Pain as Assessed by Number of Participants With a Score of 0-3 (no to Minimal Pain) on a Visual Analog Scale | 17 Participants |
| PeriAcryl90 Wound Dressing | Postoperative Pain as Assessed by Number of Participants With a Score of 0-3 (no to Minimal Pain) on a Visual Analog Scale | 16 Participants |
p-value: 0.308Z-Test for Two Population Proportions
Primary
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.
Time frame: 14 days postoperatively
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Episil Wound Dressing | Postoperative Pain as Assessed by the Number of Analgesic Pills Taken Each Day | 0 number of Ibuprofen 600mg tablets |
| PeriAcryl90 Wound Dressing | Postoperative Pain as Assessed by the Number of Analgesic Pills Taken Each Day | 1 number of Ibuprofen 600mg tablets |
p-value: 0.421Wilcoxon (Mann-Whitney)
Primary
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.
Time frame: 21 days postoperatively
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Episil Wound Dressing | Postoperative Pain as Assessed by the Number of Analgesic Pills Taken Each Day | 0 number of Ibuprofen 600mg tablets |
| PeriAcryl90 Wound Dressing | Postoperative Pain as Assessed by the Number of Analgesic Pills Taken Each Day | 0 number of Ibuprofen 600mg tablets |
p-value: 0.357Wilcoxon (Mann-Whitney)
Primary
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.
Time frame: 1 day postoperatively
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Episil Wound Dressing | Postoperative Pain as Assessed by the Number of Analgesic Pills Taken Each Day | 2 number of Ibuprofen 600mg tablets |
| PeriAcryl90 Wound Dressing | Postoperative Pain as Assessed by the Number of Analgesic Pills Taken Each Day | 3 number of Ibuprofen 600mg tablets |
p-value: 0.015Wilcoxon (Mann-Whitney)
Primary
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.
Time frame: 2 days postoperatively
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Episil Wound Dressing | Postoperative Pain as Assessed by the Number of Analgesic Pills Taken Each Day | 2 number of Ibuprofen 600mg tablets |
| PeriAcryl90 Wound Dressing | Postoperative Pain as Assessed by the Number of Analgesic Pills Taken Each Day | 3 number of Ibuprofen 600mg tablets |
p-value: 0.021Wilcoxon (Mann-Whitney)
Primary
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.
Time frame: 3 days postoperatively
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Episil Wound Dressing | Postoperative Pain as Assessed by the Number of Analgesic Pills Taken Each Day | 2 number of Ibuprofen 600mg tablets |
| PeriAcryl90 Wound Dressing | Postoperative Pain as Assessed by the Number of Analgesic Pills Taken Each Day | 2 number of Ibuprofen 600mg tablets |
p-value: 0.035Wilcoxon (Mann-Whitney)
Primary
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.
Time frame: 5 days postoperatively
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Episil Wound Dressing | Postoperative Pain as Assessed by the Number of Analgesic Pills Taken Each Day | 2 number of Ibuprofen 600mg tablets |
| PeriAcryl90 Wound Dressing | Postoperative Pain as Assessed by the Number of Analgesic Pills Taken Each Day | 2 number of Ibuprofen 600mg tablets |
p-value: 0.444Wilcoxon (Mann-Whitney)
Primary
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.
Time frame: 7 days postoperatively
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Episil Wound Dressing | Postoperative Pain as Assessed by the Number of Analgesic Pills Taken Each Day | 2 number of Ibuprofen 600mg tablets |
| PeriAcryl90 Wound Dressing | Postoperative Pain as Assessed by the Number of Analgesic Pills Taken Each Day | 2 number of Ibuprofen 600mg tablets |
p-value: 0.765Wilcoxon (Mann-Whitney)
Primary
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.
Time frame: 10 days postoperatively
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Episil Wound Dressing | Postoperative Pain as Assessed by the Number of Analgesic Pills Taken Each Day | 1 number of Ibuprofen 600mg tablets |
| PeriAcryl90 Wound Dressing | Postoperative Pain as Assessed by the Number of Analgesic Pills Taken Each Day | 1 number of Ibuprofen 600mg tablets |
p-value: 0.941Wilcoxon (Mann-Whitney)
Secondary
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.
Time frame: baseline (on the day of surgery before surgery)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Episil Wound Dressing | Gingival Blood Flow as Measured Laser Doppler Flometry (LDF) | -34.7 mL/100g/min | Standard Deviation 126.7 |
| PeriAcryl90 Wound Dressing | Gingival Blood Flow as Measured Laser Doppler Flometry (LDF) | 5.3 mL/100g/min | Standard Deviation 36 |
p-value: 0.22Paired t-Test
Secondary
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.
Time frame: 7 days postoperatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Episil Wound Dressing | Gingival Blood Flow as Measured Laser Doppler Flowmetry (LDF) | 203.9 mL/100g/min | Standard Deviation 219.8 |
| PeriAcryl90 Wound Dressing | Gingival Blood Flow as Measured Laser Doppler Flowmetry (LDF) | 169.0 mL/100g/min | Standard Deviation 197.7 |
p-value: 0.64Paired t-Test
Secondary
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.
Time frame: 21 days postoperatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Episil Wound Dressing | Gingival Blood Flow as Measured Laser Doppler Flowmetry (LDF) | 151.2 mL/100g/min | Standard Deviation 227.1 |
| PeriAcryl90 Wound Dressing | Gingival Blood Flow as Measured Laser Doppler Flowmetry (LDF) | 85.3 mL/100g/min | Standard Deviation 184.7 |
p-value: 0.375Paired t-Test
Secondary
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.
Time frame: 3 days postoperatively
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Episil Wound Dressing | Gingival Blood Flow as Measured Laser Doppler Flowmetry (LDF) | 42.5 mL/100g/min | Standard Deviation 132.1 |
| PeriAcryl90 Wound Dressing | Gingival Blood Flow as Measured Laser Doppler Flowmetry (LDF) | 50.0 mL/100g/min | Standard Deviation 152.3 |
p-value: 0.882Paired t-Test
Secondary
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.
Time frame: 14 days postoperatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Episil Wound Dressing | Gingival Blood Flow as Measured Laser Doppler Flowmetry (LDF) | 266.3 mL/100g/min | Standard Deviation 242.9 |
| PeriAcryl90 Wound Dressing | Gingival Blood Flow as Measured Laser Doppler Flowmetry (LDF) | 262.8 mL/100g/min | Standard Deviation 248.1 |
p-value: 0.967Paired t-Test
Secondary
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).
Time frame: 7 days postoperatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Episil Wound Dressing | Number of Participants With Re-epithelialization of the FGG Donor Site as Indicated by a Non-invasive Peroxide Test | 0 Participants |
| PeriAcryl90 Wound Dressing | Number of Participants With Re-epithelialization of the FGG Donor Site as Indicated by a Non-invasive Peroxide Test | 0 Participants |
Secondary
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).
Time frame: 21 days postoperatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Episil Wound Dressing | Number of Participants With Re-epithelialization of the FGG Donor Site as Indicated by a Non-invasive Peroxide Test | 6 Participants |
| PeriAcryl90 Wound Dressing | Number of Participants With Re-epithelialization of the FGG Donor Site as Indicated by a Non-invasive Peroxide Test | 5 Participants |
Secondary
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).
Time frame: 3 days postoperatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Episil Wound Dressing | Number of Participants With Re-epithelialization of the FGG Donor Site as Indicated by a Non-invasive Peroxide Test | 1 Participants |
| PeriAcryl90 Wound Dressing | Number of Participants With Re-epithelialization of the FGG Donor Site as Indicated by a Non-invasive Peroxide Test | 0 Participants |
Secondary
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).
Time frame: 14 days postoperatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Episil Wound Dressing | Number of Participants With Re-epithelialization of the FGG Donor Site as Indicated by a Non-invasive Peroxide Test | 0 Participants |
| PeriAcryl90 Wound Dressing | Number of Participants With Re-epithelialization of the FGG Donor Site as Indicated by a Non-invasive Peroxide Test | 0 Participants |