Clinical trial NCT03350724: Patient Outcomes and Gingival Blood Flow Using Laser Doppler Flowmetry Following the Use of Episil on Free Gingival Graft Donor Sites
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain From Free Gingival Graft
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2017-11-22
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Postoperative Pain as Assessed by Number of Participants With a Score of 0-3 (no to Minimal Pain) on a Visual Analog Scale
timeFrame: 1 day postoperatively
measure: Postoperative Pain as Assessed by Number of Participants With a Score of 0-3 (no to Minimal Pain) on a Visual Analog Scale
timeFrame: 2 days postoperatively
measure: Postoperative Pain as Assessed by Number of Participants With a Score of 0-3 (no to Minimal Pain) on a Visual Analog Scale
timeFrame: 3 days postoperatively
measure: Postoperative Pain as Assessed by Number of Participants With a Score of 0-3 (no to Minimal Pain) on a Visual Analog Scale
timeFrame: 5 days postoperatively
measure: Postoperative Pain as Assessed by Number of Participants With a Score of 0-3 (no to Minimal Pain) on a Visual Analog Scale
timeFrame: 7 days postoperatively
measure: Postoperative Pain as Assessed by Number of Participants With a Score of 0-3 (no to Minimal Pain) on a Visual Analog Scale
timeFrame: 10 days postoperatively
measure: Postoperative Pain as Assessed by Number of Participants With a Score of 0-3 (no to Minimal Pain) on a Visual Analog Scale
timeFrame: 14 days postoperatively
measure: Postoperative Pain as Assessed by Number of Participants With a Score of 0-3 (no to Minimal Pain) on a Visual Analog Scale
timeFrame: 21 days postoperatively
measure: Postoperative Pain as Assessed by the Number of Analgesic Pills Taken Each Day
timeFrame: 1 day postoperatively
measure: Postoperative Pain as Assessed by the Number of Analgesic Pills Taken Each Day
timeFrame: 2 days postoperatively
measure: Postoperative Pain as Assessed by the Number of Analgesic Pills Taken Each Day
timeFrame: 3 days postoperatively
measure: Postoperative Pain as Assessed by the Number of Analgesic Pills Taken Each Day
timeFrame: 5 days postoperatively
measure: Postoperative Pain as Assessed by the Number of Analgesic Pills Taken Each Day
timeFrame: 7 days postoperatively
measure: Postoperative Pain as Assessed by the Number of Analgesic Pills Taken Each Day
timeFrame: 10 days postoperatively
measure: Postoperative Pain as Assessed by the Number of Analgesic Pills Taken Each Day
timeFrame: 14 days postoperatively
measure: Postoperative Pain as Assessed by the Number of Analgesic Pills Taken Each Day
timeFrame: 21 days postoperatively
Secondary outcomes:
measure: Gingival Blood Flow as Measured Laser Doppler Flometry (LDF)
timeFrame: baseline (on the day of surgery before surgery)
measure: Gingival Blood Flow as Measured Laser Doppler Flowmetry (LDF)
timeFrame: 3 days postoperatively
measure: Gingival Blood Flow as Measured Laser Doppler Flowmetry (LDF)
timeFrame: 7 days postoperatively
measure: Gingival Blood Flow as Measured Laser Doppler Flowmetry (LDF)
timeFrame: 14 days postoperatively
measure: Gingival Blood Flow as Measured Laser Doppler Flowmetry (LDF)
timeFrame: 21 days postoperatively
measure: Number of Participants With Re-epithelialization of the FGG Donor Site as Indicated by a Non-invasive Peroxide Test
timeFrame: 3 days postoperatively
measure: Number of Participants With Re-epithelialization of the FGG Donor Site as Indicated by a Non-invasive Peroxide Test
timeFrame: 7 days postoperatively
measure: Number of Participants With Re-epithelialization of the FGG Donor Site as Indicated by a Non-invasive Peroxide Test
timeFrame: 14 days postoperatively
measure: Number of Participants With Re-epithelialization of the FGG Donor Site as Indicated by a Non-invasive Peroxide Test
timeFrame: 21 days postoperatively
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Jennifer D James, DMD, MS
role: PRINCIPAL_INVESTIGATOR
References: