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Completed

NCT Number: NCT03350724

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

episil wound dressing

Device

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 dressing

Device

PeriAcryl90 is a cyanoacrylate wound dressing.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

Secondary outcomes

  1. Gingival Blood Flow as Measured Laser Doppler Flometry (LDF)

    Time frame: 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.

  2. Gingival Blood Flow as Measured Laser Doppler Flowmetry (LDF)

    Time frame: 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.

  3. Gingival Blood Flow as Measured Laser Doppler Flowmetry (LDF)

    Time frame: 7 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.

  4. Gingival Blood Flow as Measured Laser Doppler Flowmetry (LDF)

    Time frame: 14 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.

  5. Gingival Blood Flow as Measured Laser Doppler Flowmetry (LDF)

    Time frame: 21 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.

  6. Number of Participants With Re-epithelialization of the FGG Donor Site as Indicated by a Non-invasive Peroxide Test

    Time frame: 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).

  7. Number of Participants With Re-epithelialization of the FGG Donor Site as Indicated by a Non-invasive Peroxide Test

    Time frame: 7 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).

  8. Number of Participants With Re-epithelialization of the FGG Donor Site as Indicated by a Non-invasive Peroxide Test

    Time frame: 14 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).

  9. Number of Participants With Re-epithelialization of the FGG Donor Site as Indicated by a Non-invasive Peroxide Test

    Time frame: 21 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).

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Nov 22, 2017
Registry last updated
Apr 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.