Pain From Free Gingival GraftNCT03350724
Patient Outcomes and Gingival Blood Flow Using Laser Doppler Flowmetry Following the Use of Episil on Free Gingival Graft Donor Sites
A study testing episil wound dressing and PeriAcryl90 wound dressing in people with Pain From Free Gingival Graft, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain From Free Gingival Graft
- What is being tested?
- episil wound dressing and PeriAcryl90 wound dressing
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2015to 19 May 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient of record at UTHealth School of Dentistry Houston Texas
- signed treatment plan for a FGG
- the ability to provide research informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: 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.
- Conditions
- Pain From Free Gingival Graft
- Being tested
- episil wound dressing, PeriAcryl90 wound dressing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
episil wound dressingDevice
Episil is a wound dressing material intended for the management of pain and relief of pain by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies. episil is an oromucosal liquid that transforms in situ to a bioadhesive oromucosal gel by uptake of small amounts of aqueous fluid.
PeriAcryl90 wound dressingDevice
PeriAcryl90 is a cyanoacrylate wound dressing.
| Study group | Role | What they receive |
|---|---|---|
| episil wound dressing | Experimental | 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. Receives: Device: episil wound dressing |
| PeriAcryl90 wound dressing | Active comparator | PeriAcryl90 is a cyanoacrylate wound dressing. Receives: Device: PeriAcryl90 wound dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 21 days postoperatively
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 21 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2017
- Study start29 Oct 2015
- Primary completion19 May 2017
- Study completion19 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pain From Free Gingival GraftStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer James, The University of Texas Health Science Center, Houston
- Investigators
- Jennifer D James, DMD, MS, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03350724
- Sponsor's protocol ID
- HSC-DB-15-0658
- Status last verified
- Mar 2018
- First submitted
- 17 Nov 2017
- Last updated
- 17 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03350724
- Acronym / sponsor ID
- HSC-DB-15-0658
- Conditions
- Pain From Free Gingival Graft
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 29 Oct 2015 (actual)
- Primary completion
- 19 May 2017 (actual)
- Study completion
- 19 May 2017 (actual)
- First posted
- 22 Nov 2017 (actual)
- Results
- Posted 20 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| episil wound dressing | Experimental | Device: episil wound dressingEpisil is a wound dressing material intended for the management of pain and relief of pain by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies. episil is an oromucosal liquid that transforms in situ to a bioadhesive oromucosal gel by uptake of small amounts of aqueous fluid. |
| PeriAcryl90 wound dressing | Active comparator | Device: PeriAcryl90 wound dressingPeriAcryl90 is a cyanoacrylate wound dressing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patient of record at UTHealth School of Dentistry Houston Texas
- signed treatment plan for a FGG
- the ability to provide research informed consent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| episil wound dressingEpisil 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 |
| PeriAcryl90 wound dressingPeriAcryl90 is a cyanoacrylate wound dressing. | Device | PeriAcryl90 wound dressing |
Primary outcome
Postoperative Pain as Assessed by Number of Participants With a Score of 0-3 (no to Minimal Pain) on a Visual Analog Scale
Time frame: 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 Number of Participants With a Score of 0-3 (no to Minimal Pain) on a Visual Analog Scale
Time frame: 2 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.
Postoperative Pain as Assessed by Number of Participants With a Score of 0-3 (no to Minimal Pain) on a Visual Analog Scale
Time frame: 3 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.
Postoperative Pain as Assessed by Number of Participants With a Score of 0-3 (no to Minimal Pain) on a Visual Analog Scale
Time frame: 5 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.
Postoperative Pain as Assessed by Number of Participants With a Score of 0-3 (no to Minimal Pain) on a Visual Analog Scale
Time frame: 7 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.
Postoperative Pain as Assessed by Number of Participants With a Score of 0-3 (no to Minimal Pain) on a Visual Analog Scale
Time frame: 10 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.
Postoperative Pain as Assessed by Number of Participants With a Score of 0-3 (no to Minimal Pain) on a Visual Analog Scale
Time frame: 14 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.
Postoperative Pain as Assessed by Number of Participants With a Score of 0-3 (no to Minimal Pain) on a Visual Analog Scale
Time frame: 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.
Postoperative Pain as Assessed by the Number of Analgesic Pills Taken Each Day
Time frame: 1 day postoperatively
Postoperative pain will be determined by the subjects recording the number of analgesic pills (Ibuprofen 600mg tablets) taken each day.
Postoperative Pain as Assessed by the Number of Analgesic Pills Taken Each Day
Time frame: 2 days postoperatively
Postoperative pain will be determined by the subjects recording the number of analgesic pills (Ibuprofen 600mg tablets) taken each day.
Postoperative Pain as Assessed by the Number of Analgesic Pills Taken Each Day
Time frame: 3 days postoperatively
Postoperative pain will be determined by the subjects recording the number of analgesic pills (Ibuprofen 600mg tablets) taken each day.
Postoperative Pain as Assessed by the Number of Analgesic Pills Taken Each Day
Time frame: 5 days postoperatively
Postoperative pain will be determined by the subjects recording the number of analgesic pills (Ibuprofen 600mg tablets) taken each day.
Postoperative Pain as Assessed by the Number of Analgesic Pills Taken Each Day
Time frame: 7 days postoperatively
Postoperative pain will be determined by the subjects recording the number of analgesic pills (Ibuprofen 600mg tablets) taken each day.
Postoperative Pain as Assessed by the Number of Analgesic Pills Taken Each Day
Time frame: 10 days postoperatively
Postoperative pain will be determined by the subjects recording the number of analgesic pills (Ibuprofen 600mg tablets) taken each day.
Postoperative Pain as Assessed by the Number of Analgesic Pills Taken Each Day
Time frame: 14 days postoperatively
Postoperative pain will be determined by the subjects recording the number of analgesic pills (Ibuprofen 600mg tablets) taken each day.
Postoperative Pain as Assessed by the Number of Analgesic Pills Taken Each Day
Time frame: 21 days postoperatively
Postoperative pain will be determined by the subjects recording the number of analgesic pills taken each day.
9 secondary outcomes
Gingival Blood Flow as Measured Laser Doppler Flometry (LDF)
Time frame: baseline (on the day of surgery before surgery)
Gingival Blood Flow as Measured Laser Doppler Flowmetry (LDF)
Time frame: 3 days postoperatively
Gingival Blood Flow as Measured Laser Doppler Flowmetry (LDF)
Time frame: 7 days postoperatively
Gingival Blood Flow as Measured Laser Doppler Flowmetry (LDF)
Time frame: 14 days postoperatively
Gingival Blood Flow as Measured Laser Doppler Flowmetry (LDF)
Time frame: 21 days postoperatively
Number of Participants With Re-epithelialization of the FGG Donor Site as Indicated by a Non-invasive Peroxide Test
Time frame: 3 days postoperatively
Number of Participants With Re-epithelialization of the FGG Donor Site as Indicated by a Non-invasive Peroxide Test
Time frame: 7 days postoperatively
Number of Participants With Re-epithelialization of the FGG Donor Site as Indicated by a Non-invasive Peroxide Test
Time frame: 14 days postoperatively
Number of Participants With Re-epithelialization of the FGG Donor Site as Indicated by a Non-invasive Peroxide Test
Time frame: 21 days postoperatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer D James, DMD, MS principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing episil wound dressing and PeriAcryl90 wound dressing in people with Pain From Free Gingival Graft, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain as Assessed by Number of Participants With a Score of 0-3 (no to Minimal Pain) on a Visual Analog Scale (time frame: 1 day postoperatively). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2018.