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

Study Overview
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Brief Summary
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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).

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

Conditions
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Palatal Wound

Intervention / Treatment
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* Device: Allogenic amnion chorion membrane
* Device: Collagen dressing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients attending the Clinic for Graduate Periodontics at The University of Texas health Science Center at Houston School of Dentistry 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Allogenic amnion chorion membrane<br>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<br>* Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery.<br>|
| Active Comparator: Collagen dressing<br>Collagen dressing is used to cover wounds in dental surgery. | Device: Collagen dressing<br>* Collagen dressing is used to cover wounds in dental surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Size of Wound Area | 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. | baseline | 
| Size of Wound Area | 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 days | 
| Size of Wound Area | 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. | 10 days | 
| Size of Wound Area | 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. | 14 days | 
| Size of Wound Area | 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. | 21 days | 
| Size of Wound Area | 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. | 28 days | 
| Size of Wound Area | 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. | 45 days | 
| Size of Wound Area | 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. | 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Stratified as Per the Degree of Epithelialization of Wound | 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. | baseline | 
| Number of Participants Stratified as Per the Degree of Epithelialization of Wound | 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 days | 
| Number of Participants Stratified as Per the Degree of Epithelialization of Wound | 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. | 10 days | 
| Number of Participants Stratified as Per the Degree of Epithelialization of Wound | 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. | 14 days | 
| Number of Participants Stratified as Per the Degree of Epithelialization of Wound | 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. | 21 days | 
| Number of Participants Stratified as Per the Degree of Epithelialization of Wound | 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. | 28 days | 
| Number of Participants Stratified as Per the Degree of Epithelialization of Wound | 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. | 45 days | 
| Number of Participants Stratified as Per the Degree of Epithelialization of Wound | 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. | 60 days | 
| Relative Difference in Color of Wound Site Compared to Adjacent Gingiva | 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. | baseline | 
| Relative Difference in Color of Wound Site Compared to Adjacent Gingiva | 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. | 4 days | 
| Relative Difference in Color of Wound Site Compared to Adjacent Gingiva | 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 days | 
| Relative Difference in Color of Wound Site Compared to Adjacent Gingiva | 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 days | 
| Relative Difference in Color of Wound Site Compared to Adjacent Gingiva | 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. | 21 days | 
| Relative Difference in Color of Wound Site Compared to Adjacent Gingiva | 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. | 28 days | 
| Relative Difference in Color of Wound Site Compared to Adjacent Gingiva | 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. | 45 days | 
| Relative Difference in Color of Wound Site Compared to Adjacent Gingiva | 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. | 60 days | 
| Number of Participants With Haemostasis of Wound Area | Haemostasis is achieved when no bleeding of the wound site is actively seen. | baseline | 
| Number of Participants With Haemostasis of Wound Area | Haemostasis is achieved when no bleeding of the wound site is actively seen. | 4 days | 
| Number of Participants With Haemostasis of Wound Area | Haemostasis is achieved when no bleeding of the wound site is actively seen. | 10 days | 
| Number of Participants With Haemostasis of Wound Area | Haemostasis is achieved when no bleeding of the wound site is actively seen. | 14 days | 
| Number of Participants With Haemostasis of Wound Area | Haemostasis is achieved when no bleeding of the wound site is actively seen. | 21 days | 
| Number of Participants With Haemostasis of Wound Area | Haemostasis is achieved when no bleeding of the wound site is actively seen. | 28 days | 
| Number of Participants With Haemostasis of Wound Area | Haemostasis is achieved when no bleeding of the wound site is actively seen. | 45 days | 
| Number of Participants With Haemostasis of Wound Area | Haemostasis is achieved when no bleeding of the wound site is actively seen. | 60 days | 
| Pain as Assessed by a Visual Analogue Scale (VAS) | 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. | baseline | 
| Pain as Assessed by a Visual Analogue Scale (VAS) | 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. | 4 days | 
| Pain as Assessed by a Visual Analogue Scale (VAS) | 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. | 10 days | 
| Pain as Assessed by a Visual Analogue Scale (VAS) | 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. | 14 days | 
| Pain as Assessed by a Visual Analogue Scale (VAS) | 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. | 21 days | 
| Pain as Assessed by a Visual Analogue Scale (VAS) | 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 days | 
| Pain as Assessed by a Visual Analogue Scale (VAS) | 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. | 45 days | 
| Pain as Assessed by a Visual Analogue Scale (VAS) | 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. | 60 days | 
| Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) | Sensibility 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): no loss of sensation, mild/moderate loss of sensation, or severe loss of sensation. | baseline | 
| Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) | Sensibility will be assessed with a periodontal probe using a rubbing movement and pin-pressure nociception. Patients will be asked to rate their sensibility based on a 3-point verbal descriptor scale (VDS): no loss of sensation, mild/moderate loss of sensation, or severe loss of sensation. | 4 days | 
| Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) | Sensibility will be assessed with a periodontal probe using a rubbing movement and pin-pressure nociception. Patients will be asked to rate their sensibility based on a 3-point verbal descriptor scale (VDS): no loss of sensation, mild/moderate loss of sensation, or severe loss of sensation. | 10 days | 
| Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) | Sensibility will be assessed with a periodontal probe using a rubbing movement and pin-pressure nociception. Patients will be asked to rate their sensibility based on a 3-point verbal descriptor scale (VDS): no loss of sensation, mild/moderate loss of sensation, or severe loss of sensation. | 14 days | 
| Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) | Sensibility will be assessed with a periodontal probe using a rubbing movement and pin-pressure nociception. Patients will be asked to rate their sensibility based on a 3-point verbal descriptor scale (VDS): no loss of sensation, mild/moderate loss of sensation, or severe loss of sensation. | 21 days | 
| Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) | Sensibility will be assessed with a periodontal probe using a rubbing movement and pin-pressure nociception. Patients will be asked to rate their sensibility based on a 3-point verbal descriptor scale (VDS): no loss of sensation, mild/moderate loss of sensation, or severe loss of sensation. | 28 days | 
| Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) | Sensibility will be assessed with a periodontal probe using a rubbing movement and pin-pressure nociception. Patients will be asked to rate their sensibility based on a 3-point verbal descriptor scale (VDS): no loss of sensation, mild/moderate loss of sensation, or severe loss of sensation. | 45 days | 
| Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) | Sensibility will be assessed with a periodontal probe using a rubbing movement and pin-pressure nociception. Patients will be asked to rate their sensibility based on a 3-point verbal descriptor scale (VDS): no loss of sensation, mild/moderate loss of sensation, or severe loss of sensation. | 60 days | 
| Volume of Wound | The wound area will analyzed with an intraoral scanner, and three-dimensional images will be reconstructed to determine the volume of the wound. | baseline | 
| Volume of Wound | The wound area will analyzed with an intraoral scanner, and three-dimensional images will be reconstructed to determine the volume of the wound. | 4 days | 
| Volume of Wound | The wound area will analyzed with an intraoral scanner, and three-dimensional images will be reconstructed to determine the volume of the wound. | 10 days | 
| Volume of Wound | The wound area will analyzed with an intraoral scanner, and three-dimensional images will be reconstructed to determine the volume of the wound. | 14 days | 
| Volume of Wound | The wound area will analyzed with an intraoral scanner, and three-dimensional images will be reconstructed to determine the volume of the wound. | 21 days | 
| Volume of Wound | The wound area will analyzed with an intraoral scanner, and three-dimensional images will be reconstructed to determine the volume of the wound. | 28 days | 
| Volume of Wound | The wound area will analyzed with an intraoral scanner, and three-dimensional images will be reconstructed to determine the volume of the wound. | 45 days | 
| Volume of Wound | The wound area will analyzed with an intraoral scanner, and three-dimensional images will be reconstructed to determine the volume of the wound. | 60 days | 
| Clinician's Feedback on the Wound Dressing Material as Assessed by a Questionnaire |  | at the time of placement of the wound dressing material | 
| Number of Neutrophil Cells as Assessed by Light Microscopy of Haematoxylin and Eosin (H&E)-Stained Biopsy Sections | Gingival specimen biopsies (4mm in diameter, 1.5mm in thickness) will be harvested. The histological sections will be evaluated using a Nikon light microscope. | baseline | 
| Number of Neutrophil Cells as Assessed by Light Microscopy of Haematoxylin and Eosin (H&E)-Stained Biopsy Sections | Gingival specimen biopsies (4mm in diameter, 1.5mm in thickness) will be harvested. The histological sections will be evaluated using a Nikon light microscope. | 10 days | 
| Change in Percentage of Collagen Density in Wound Area as Assessed by Light Microscopy of Masson's Trichrome-stained Biopsy Sections |  | baseline, 10 days | 
| Thickness of the Epithelium as Assessed by Light Microscopy of Haematoxylin and Eosin (H&E)-Stained Biopsy Sections | 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-Elements Advanced Research (AR) Imagine Software will be used to calculate the thickness of the epithelium. | baseline | 
| Thickness of the Epithelium as Assessed by Light Microscopy of Haematoxylin and Eosin (H&E)-Stained Biopsy Sections | 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-Elements Advanced Research (AR) Imagine Software will be used to calculate the thickness of the epithelium. | 10 days | 
| Angiogenesis as Indicated by Number of Blood Vessels as Assessed by Light Microscopy of Biopsy Sections Immunohistochemically Stained to Detect Factor VIII (Von Willebrandt Factor) |  | baseline | 
| Angiogenesis as Indicated by Number of Blood Vessels as Assessed by Light Microscopy of Biopsy Sections Immunohistochemically Stained to Detect Factor VIII (Von Willebrandt Factor) | 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. | 10 days |