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Clinical and Histological Outcomes of Allogenic Amnion Chorion Membrane in the Healing of Free Gingival Graft Donor Site

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ClinicalTrials.gov Identifier: NCT03713073
Recruitment Status : Recruiting
First Posted : October 19, 2018
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
Chun-Teh Lee, The University of Texas Health Science Center, Houston

Tracking Information
First Submitted Date  ICMJE October 17, 2018
First Posted Date  ICMJE October 19, 2018
Last Update Posted Date April 18, 2019
Actual Study Start Date  ICMJE October 3, 2016
Estimated Primary Completion Date October 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 17, 2018)
  • Size of wound area [ Time Frame: baseline ]
    The wound area will be assessed by means of a clinical picture. The picture will be taken with an angulation perpendicular to the wound. A periodontal probe will be placed by the wound as a reference scale. Wound area is defined as the area without epithelization. The wound area on the picture will be measured by ImageJ.
  • Size of wound area [ Time Frame: 4 days ]
    The wound area will be assessed by means of a clinical picture. The picture will be taken with an angulation perpendicular to the wound. A periodontal probe will be placed by the wound as a reference scale. Wound area is defined as the area without epithelization. The wound area on the picture will be measured by ImageJ.
  • Size of wound area [ Time Frame: 10 days ]
    The wound area will be assessed by means of a clinical picture. The picture will be taken with an angulation perpendicular to the wound. A periodontal probe will be placed by the wound as a reference scale. Wound area is defined as the area without epithelization. The wound area on the picture will be measured by ImageJ.
  • Size of wound area [ Time Frame: 2 weeks ]
    The wound area will be assessed by means of a clinical picture. The picture will be taken with an angulation perpendicular to the wound. A periodontal probe will be placed by the wound as a reference scale. Wound area is defined as the area without epithelization. The wound area on the picture will be measured by ImageJ.
  • Size of wound area [ Time Frame: 3 weeks ]
    The wound area will be assessed by means of a clinical picture. The picture will be taken with an angulation perpendicular to the wound. A periodontal probe will be placed by the wound as a reference scale. Wound area is defined as the area without epithelization. The wound area on the picture will be measured by ImageJ.
  • Size of wound area [ Time Frame: 4 weeks ]
    The wound area will be assessed by means of a clinical picture. The picture will be taken with an angulation perpendicular to the wound. A periodontal probe will be placed by the wound as a reference scale. Wound area is defined as the area without epithelization. The wound area on the picture will be measured by ImageJ.
  • Size of wound area [ Time Frame: 6 weeks ]
    The wound area will be assessed by means of a clinical picture. The picture will be taken with an angulation perpendicular to the wound. A periodontal probe will be placed by the wound as a reference scale. Wound area is defined as the area without epithelization. The wound area on the picture will be measured by ImageJ.
  • Size of wound area [ Time Frame: 8 weeks ]
    The wound area will be assessed by means of a clinical picture. The picture will be taken with an angulation perpendicular to the wound. A periodontal probe will be placed by the wound as a reference scale. Wound area is defined as the area without epithelization. The wound area on the picture will be measured by ImageJ.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03713073 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2018)
  • Degree of epithelialization of wound [ Time Frame: baseline ]
    Epithelialization is measured by means of bubble formation after dripping hydrogen peroxide (3%) to the wound surface. Less bubbles indicate greater epithelialization, and epithelialization will be ranked as total, partial or none.
  • Degree of epithelialization of wound [ Time Frame: 4 days ]
    Epithelialization is measured by means of bubble formation after dripping hydrogen peroxide (3%) to the wound surface. Less bubbles indicate greater epithelialization, and epithelialization will be ranked as total, partial or none.
  • Degree of epithelialization of wound [ Time Frame: 10 days ]
    Epithelialization is measured by means of bubble formation after dripping hydrogen peroxide (3%) to the wound surface. Less bubbles indicate greater epithelialization, and epithelialization will be ranked as total, partial or none.
  • Degree of epithelialization of wound [ Time Frame: 2 weeks ]
    Epithelialization is measured by means of bubble formation after dripping hydrogen peroxide (3%) to the wound surface. Less bubbles indicate greater epithelialization, and epithelialization will be ranked as total, partial or none.
  • Degree of epithelialization of wound [ Time Frame: 3 weeks ]
    Epithelialization is measured by means of bubble formation after dripping hydrogen peroxide (3%) to the wound surface. Less bubbles indicate greater epithelialization, and epithelialization will be ranked as total, partial or none.
  • Degree of epithelialization of wound [ Time Frame: 4 weeks ]
    Epithelialization is measured by means of bubble formation after dripping hydrogen peroxide (3%) to the wound surface. Less bubbles indicate greater epithelialization, and epithelialization will be ranked as total, partial or none.
  • Degree of epithelialization of wound [ Time Frame: 6 weeks ]
    Epithelialization is measured by means of bubble formation after dripping hydrogen peroxide (3%) to the wound surface. Less bubbles indicate greater epithelialization, and epithelialization will be ranked as total, partial or none.
  • Degree of epithelialization of wound [ Time Frame: 8 weeks ]
    Epithelialization is measured by means of bubble formation after dripping hydrogen peroxide (3%) to the wound surface. Less bubbles indicate greater epithelialization, and epithelialization will be ranked as total, partial or none.
  • Relative difference in color of wound site compared to adjacent gingiva [ Time Frame: baseline ]
    The color of wound site will be compared to the adjacent gingiva by using a 4-point scale: 1. Obvious difference; 2. Noticeable difference; 3. Disguisable difference; or 4. No noticeable difference in comparison with adjacent gingiva.
  • Relative difference in color of wound site compared to adjacent gingiva [ Time Frame: 4 days ]
    The color of wound site will be compared to the adjacent gingiva by using a 4-point scale: 1. Obvious difference; 2. Noticeable difference; 3. Disguisable difference; or 4. No noticeable difference in comparison with adjacent gingiva.
  • Relative difference in color of wound site compared to adjacent gingiva [ Time Frame: 10 days ]
    The color of wound site will be compared to the adjacent gingiva by using a 4-point scale: 1. Obvious difference; 2. Noticeable difference; 3. Disguisable difference; or 4. No noticeable difference in comparison with adjacent gingiva.
  • Relative difference in color of wound site compared to adjacent gingiva [ Time Frame: 2 weeks ]
    The color of wound site will be compared to the adjacent gingiva by using a 4-point scale: 1. Obvious difference; 2. Noticeable difference; 3. Disguisable difference; or 4. No noticeable difference in comparison with adjacent gingiva.
  • Relative difference in color of wound site compared to adjacent gingiva [ Time Frame: 3 weeks ]
    The color of wound site will be compared to the adjacent gingiva by using a 4-point scale: 1. Obvious difference; 2. Noticeable difference; 3. Disguisable difference; or 4. No noticeable difference in comparison with adjacent gingiva.
  • Relative difference in color of wound site compared to adjacent gingiva [ Time Frame: 4 weeks ]
    The color of wound site will be compared to the adjacent gingiva by using a 4-point scale: 1. Obvious difference; 2. Noticeable difference; 3. Disguisable difference; or 4. No noticeable difference in comparison with adjacent gingiva.
  • Relative difference in color of wound site compared to adjacent gingiva [ Time Frame: 6 weeks ]
    The color of wound site will be compared to the adjacent gingiva by using a 4-point scale: 1. Obvious difference; 2. Noticeable difference; 3. Disguisable difference; or 4. No noticeable difference in comparison with adjacent gingiva.
  • Relative difference in color of wound site compared to adjacent gingiva [ Time Frame: 8 weeks ]
    The color of wound site will be compared to the adjacent gingiva by using a 4-point scale: 1. Obvious difference; 2. Noticeable difference; 3. Disguisable difference; or 4. No noticeable difference in comparison with adjacent gingiva.
  • Number of participants with haemostasis of wound area [ Time Frame: baseline ]
    Haemostasis is achieved when no bleeding of the wound site is actively seen.
  • Number of participants with haemostasis of wound area [ Time Frame: 4 days ]
    Haemostasis is achieved when no bleeding of the wound site is actively seen.
  • Number of participants with haemostasis of wound area [ Time Frame: 10 days ]
    Haemostasis is achieved when no bleeding of the wound site is actively seen.
  • Number of participants with haemostasis of wound area [ Time Frame: 2 weeks ]
    Haemostasis is achieved when no bleeding of the wound site is actively seen.
  • Number of participants with haemostasis of wound area [ Time Frame: 3 weeks ]
    Haemostasis is achieved when no bleeding of the wound site is actively seen.
  • Number of participants with haemostasis of wound area [ Time Frame: 4 weeks ]
    Haemostasis is achieved when no bleeding of the wound site is actively seen.
  • Number of participants with haemostasis of wound area [ Time Frame: 6 weeks ]
    Haemostasis is achieved when no bleeding of the wound site is actively seen.
  • Number of participants with haemostasis of wound area [ Time Frame: 8 weeks ]
    Haemostasis is achieved when no bleeding of the wound site is actively seen.
  • Pain as assessed by a Visual Analogue Scale (VAS) [ Time Frame: baseline ]
    Pain will be assessed by a Visual Analogue Scale (VAS). Scores range form 0 to 10. 0 indicates no pain, 1 indicates minimal pain, and 10 indicates severe pain.
  • Pain as assessed by a Visual Analogue Scale (VAS) [ Time Frame: 4 days ]
    Pain will be assessed by a Visual Analogue Scale (VAS). Scores range form 0 to 10. 0 indicates no pain, 1 indicates minimal pain, and 10 indicates severe pain.
  • Pain as assessed by a Visual Analogue Scale (VAS) [ Time Frame: 10 days ]
    Pain will be assessed by a Visual Analogue Scale (VAS). Scores range form 0 to 10. 0 indicates no pain, 1 indicates minimal pain, and 10 indicates severe pain.
  • Pain as assessed by a Visual Analogue Scale (VAS) [ Time Frame: 2 weeks ]
    Pain will be assessed by a Visual Analogue Scale (VAS). Scores range form 0 to 10. 0 indicates no pain, 1 indicates minimal pain, and 10 indicates severe pain.
  • Pain as assessed by a Visual Analogue Scale (VAS) [ Time Frame: 3 weeks ]
    Pain will be assessed by a Visual Analogue Scale (VAS). Scores range form 0 to 10. 0 indicates no pain, 1 indicates minimal pain, and 10 indicates severe pain.
  • Pain as assessed by a Visual Analogue Scale (VAS) [ Time Frame: 4 weeks ]
    Pain will be assessed by a Visual Analogue Scale (VAS). Scores range form 0 to 10. 0 indicates no pain, 1 indicates minimal pain, and 10 indicates severe pain.
  • Pain as assessed by a Visual Analogue Scale (VAS) [ Time Frame: 6 weeks ]
    Pain will be assessed by a Visual Analogue Scale (VAS). Scores range form 0 to 10. 0 indicates no pain, 1 indicates minimal pain, and 10 indicates severe pain.
  • Pain as assessed by a Visual Analogue Scale (VAS) [ Time Frame: 8 weeks ]
    Pain will be assessed by a Visual Analogue Scale (VAS). Scores range form 0 to 10. 0 indicates no pain, 1 indicates minimal pain, and 10 indicates severe pain.
  • Sensitivity of the wound area as assessed by a 3-point verbal descriptor scale (VDS) [ Time Frame: baseline ]
    Sensitivity will be assessed with a periodontal probe using a rubbing movement and pin-pressure nociception. Patients will be asked to rate their sensitivity based on a 3-point verbal descriptor scale (VDS): none, mild/moderate, or severe.
  • Sensitivity of the wound area as assessed by a 3-point verbal descriptor scale (VDS) [ Time Frame: 4 days ]
    Sensitivity will be assessed with a periodontal probe using a rubbing movement and pin-pressure nociception. Patients will be asked to rate their sensitivity based on a 3-point verbal descriptor scale (VDS): none, mild/moderate, or severe.
  • Sensitivity of the wound area as assessed by a 3-point verbal descriptor scale (VDS) [ Time Frame: 10 days ]
    Sensitivity will be assessed with a periodontal probe using a rubbing movement and pin-pressure nociception. Patients will be asked to rate their sensitivity based on a 3-point verbal descriptor scale (VDS): none, mild/moderate, or severe.
  • Sensitivity of the wound area as assessed by a 3-point verbal descriptor scale (VDS) [ Time Frame: 2 weeks ]
    Sensitivity will be assessed with a periodontal probe using a rubbing movement and pin-pressure nociception. Patients will be asked to rate their sensitivity based on a 3-point verbal descriptor scale (VDS): none, mild/moderate, or severe.
  • Sensitivity of the wound area as assessed by a 3-point verbal descriptor scale (VDS) [ Time Frame: 3 weeks ]
    Sensitivity will be assessed with a periodontal probe using a rubbing movement and pin-pressure nociception. Patients will be asked to rate their sensitivity based on a 3-point verbal descriptor scale (VDS): none, mild/moderate, or severe.
  • Sensitivity of the wound area as assessed by a 3-point verbal descriptor scale (VDS) [ Time Frame: 4 weeks ]
    Sensitivity will be assessed with a periodontal probe using a rubbing movement and pin-pressure nociception. Patients will be asked to rate their sensitivity based on a 3-point verbal descriptor scale (VDS): none, mild/moderate, or severe.
  • Sensitivity of the wound area as assessed by a 3-point verbal descriptor scale (VDS) [ Time Frame: 6 weeks ]
    Sensitivity will be assessed with a periodontal probe using a rubbing movement and pin-pressure nociception. Patients will be asked to rate their sensitivity based on a 3-point verbal descriptor scale (VDS): none, mild/moderate, or severe.
  • Sensitivity of the wound area as assessed by a 3-point verbal descriptor scale (VDS) [ Time Frame: 8 weeks ]
    Sensitivity will be assessed with a periodontal probe using a rubbing movement and pin-pressure nociception. Patients will be asked to rate their sensitivity based on a 3-point verbal descriptor scale (VDS): none, mild/moderate, or severe.
  • Volume of wound [ Time Frame: baseline ]
    The wound area will analyzed with an intraoral scanner, and three-dimensional images will be reconstructed to determine the volume of the wound.
  • Volume of wound [ Time Frame: 4 days ]
    The wound area will analyzed with an intraoral scanner, and three-dimensional images will be reconstructed to determine the volume of the wound.
  • Volume of wound [ Time Frame: 10 days ]
    The wound area will analyzed with an intraoral scanner, and three-dimensional images will be reconstructed to determine the volume of the wound.
  • Volume of wound [ Time Frame: 2 weeks ]
    The wound area will analyzed with an intraoral scanner, and three-dimensional images will be reconstructed to determine the volume of the wound.
  • Volume of wound [ Time Frame: 3 weeks ]
    The wound area will analyzed with an intraoral scanner, and three-dimensional images will be reconstructed to determine the volume of the wound.
  • Volume of wound [ Time Frame: 4 weeks ]
    The wound area will analyzed with an intraoral scanner, and three-dimensional images will be reconstructed to determine the volume of the wound.
  • Volume of wound [ Time Frame: 6 weeks ]
    The wound area will analyzed with an intraoral scanner, and three-dimensional images will be reconstructed to determine the volume of the wound.
  • Volume of wound [ Time Frame: 8 weeks ]
    The wound area will analyzed with an intraoral scanner, and three-dimensional images will be reconstructed to determine the volume of the wound.
  • Clinician's feedback on the wound dressing material as assessed by a questionnaire [ Time Frame: at the time of placement of the wound dressing material ]
  • Cellular composition of inflammatory infiltrates as assessed by light microscopy of haematoxylin and eosin (H&E)-stained biopsy sections [ Time Frame: baseline ]
    Gingival specimen biopsies (4mm in diameter, 1.5mm in thickness) will be harvested. The histological sections will be evaluated using a Nikon light microscope.
  • Cellular composition of inflammatory infiltrates as assessed by light microscopy of haematoxylin and eosin (H&E)-stained biopsy sections [ Time Frame: 10 days ]
    Gingival specimen biopsies (4mm in diameter, 1.5mm in thickness) will be harvested. The histological sections will be evaluated using a Nikon light microscope.
  • Percentage of new collagen as assessed by light microscopy of Masson's trichrome-stained biopsy sections [ Time Frame: baseline ]
  • Percentage of new collagen as assessed by light microscopy of Masson's trichrome-stained biopsy sections [ Time Frame: 10 days ]
    Gingival specimen biopsies (4mm in diameter, 1.5mm in thickness) will be harvested. The histological sections will be evaluated using a Nikon light microscope, and Nikon NIS Element AR Imagine Software will be used to calculate the percentage of the new collagen.
  • Thickness of the epithelium as assessed by light microscopy of haematoxylin and eosin (H&E)-stained biopsy sections [ Time Frame: baseline ]
    Gingival specimen biopsies (4mm in diameter, 1.5mm in thickness) will be harvested. The histological sections will be evaluated using a Nikon light microscope, and Nikon NIS Element AR Imagine Software will be used to calculate the thickness of the epithelium.
  • Thickness of the epithelium as assessed by light microscopy of haematoxylin and eosin (H&E)-stained biopsy sections [ Time Frame: 10 days ]
    Gingival specimen biopsies (4mm in diameter, 1.5mm in thickness) will be harvested. The histological sections will be evaluated using a Nikon light microscope, and Nikon NIS Element AR Imagine Software will be used to calculate the thickness of the epithelium.
  • Angiogenesis as assessed by light microscopy of biopsy sections immunohistochemically stained to detect factor VIII (von Willebrandt factor) [ Time Frame: baseline ]
  • Angiogenesis as assessed by light microscopy of biopsy sections immunohistochemically stained to detect factor VIII (von Willebrandt factor) [ Time Frame: 10 days ]
    Gingival specimen biopsies (4mm in diameter, 1.5mm in thickness) will be harvested. The histological sections will be evaluated using a Nikon light microscope, and the area of angiogenesis will be quantified using Nikon NIS Element AR Imagine Software.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical and Histological Outcomes of Allogenic Amnion Chorion Membrane in the Healing of Free Gingival Graft Donor Site
Official Title  ICMJE Clinical and Histological Outcomes of Allogenic Amnion Chorion Membrane in the Healing of Free Gingival Graft Donor Site
Brief Summary The purpose of this study is to compare an allogenic amnion chorion membrane to a collagen dressing in palatal wound healing after harvesting free gingival graft (FGG).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
The study is a "split-mouth design" , in which two treatments (test and control) are randomly assigned to either the right or left halves of the dentition/palate.
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Palatal Wound
Intervention  ICMJE
  • Device: Allogenic amnion chorion membrane
    Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery.
  • Device: Collagen dressing
    Collagen dressing is used to cover wounds in dental surgery.
Study Arms  ICMJE
  • Experimental: Allogenic amnion chorion membrane
    Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery.
    Intervention: Device: Allogenic amnion chorion membrane
  • Active Comparator: Collagen dressing
    Collagen dressing is used to cover wounds in dental surgery.
    Intervention: Device: Collagen dressing
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 17, 2018)
18
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 1, 2020
Estimated Primary Completion Date October 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • patients attending the Clinic for Graduate Periodontics at The University of Texas health Science Center at Houston School of Denstistry who are in need of a Free Gingival Graft procedure to augment keratinized gingiva, augment ridge, or cover recession defects.
  • systemically healthy or with controlled common systemic conditions, such as hypertension, that will not affect wound healing.

Exclusion Criteria:

  • size of the FGG that the patient needs bigger than the size of FGGs that have to be harvested in this study (two 8mm (width) x 10mm (length) x ≈1.5mm (thickness) FGG).
  • current heavy smokers(>10 cigarettes/day) (patients who stop smoking more than one year are eligible)
  • have diabetes or other systemic diseases that may comprise healing
  • take antibiotics and/or analgesics within one week before the procedure and have loss of sensation on the palate
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Chun-Teh Lee, DDS, MS, DMSC 713-486-4384 Chun-Teh.Lee@uth.tmc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03713073
Other Study ID Numbers  ICMJE HSC-DB-18-0303
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chun-Teh Lee, The University of Texas Health Science Center, Houston
Study Sponsor  ICMJE The University of Texas Health Science Center, Houston
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Chun-Teh Lee The University of Texas Health Science Center, Houston
PRS Account The University of Texas Health Science Center, Houston
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP