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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

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).

Condition or disease Intervention/treatment Phase
Palatal Wound Device: Allogenic amnion chorion membrane Device: Collagen dressing Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
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
Official Title: Clinical and Histological Outcomes of Allogenic Amnion Chorion Membrane in the Healing of Free Gingival Graft Donor Site
Actual Study Start Date : October 3, 2016
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Collagen

Arm Intervention/treatment
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.
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.

Active Comparator: Collagen dressing
Collagen dressing is used to cover wounds in dental surgery.
Device: Collagen dressing
Collagen dressing is used to cover wounds in dental surgery.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. Number of participants with haemostasis of wound area [ Time Frame: baseline ]
    Haemostasis is achieved when no bleeding of the wound site is actively seen.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

  22. 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.

  23. 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.

  24. 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.

  25. 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.

  26. 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.

  27. 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.

  28. 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.

  29. 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.

  30. 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.

  31. 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.

  32. 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.

  33. 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.

  34. 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.

  35. 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.

  36. 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.

  37. 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.

  38. 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.

  39. 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.

  40. 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.

  41. 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.

  42. 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.

  43. 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.

  44. 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.

  45. 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.

  46. 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.

  47. 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.

  48. 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.

  49. 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 ]
  50. 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.

  51. 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.

  52. Percentage of new collagen as assessed by light microscopy of Masson's trichrome-stained biopsy sections [ Time Frame: baseline ]
  53. 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.

  54. 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.

  55. 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.

  56. Angiogenesis as assessed by light microscopy of biopsy sections immunohistochemically stained to detect factor VIII (von Willebrandt factor) [ Time Frame: baseline ]
  57. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03713073


Contacts
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Contact: Chun-Teh Lee, DDS, MS, DMSC 713-486-4384 Chun-Teh.Lee@uth.tmc.edu

Locations
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United States, Texas
The University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact: Chun-Teh Lee, DDS, MS, DMSC    713-486-4384    Chun-Teh.Lee@uth.tmc.edu   
Principal Investigator: Seonghong Min, DDS, MS, PhD         
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
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Principal Investigator: Chun-Teh Lee The University of Texas Health Science Center, Houston

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Responsible Party: Chun-Teh Lee, Assistant Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT03713073     History of Changes
Other Study ID Numbers: HSC-DB-18-0303
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019

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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