Palatal Wound
Conditions
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).
Interventions
DEVICEAllogenic 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.
DEVICECollagen dressing
Collagen dressing is used to cover wounds in dental surgery.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Size of Wound Area | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Relative Difference in Color of Wound Site Compared to Adjacent Gingiva | 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. |
| Number of Participants With Haemostasis of Wound Area | baseline | Haemostasis is achieved when no bleeding of the wound site is actively seen. |
| Pain as Assessed by a Visual Analogue Scale (VAS) | 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. |
| Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) | baseline | 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. |
| Volume of Wound | baseline | The wound area will analyzed with an intraoral scanner, and three-dimensional images will be reconstructed to determine the volume of the wound. |
| Number of Participants Stratified as Per the Degree of Epithelialization of Wound | 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. |
| Number of Neutrophil Cells as Assessed by Light Microscopy of Haematoxylin and Eosin (H&E)-Stained Biopsy Sections | 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. |
| 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 | 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-Elements Advanced Research (AR) Imagine Software will be used to calculate the thickness of the epithelium. |
| 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 | — |
| Clinician's Feedback on the Wound Dressing Material as Assessed by a Questionnaire | at the time of placement of the wound dressing material | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants The study is a split-mouth design. For each participant, there were 2 palatal wound sites (one on the right side and one on the left side), and for each participant, allogenic amnion chorion membrane (ACM) was placed on one of the wound sites and collagen dressing was placed on the other wound site. In other words, each participant received both interventions, and the interventions were received at the same time. The side of placement of the two interventions was randomized.
Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery. Collagen dressing is used to cover wounds in dental surgery. | 19 |
| Total | 19 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants |
| Age, Continuous | 54.55 years STANDARD_DEVIATION 11.16 |
| Body mass index (BMI) 18.5-24.9 kg/m² | 13 Participants |
| Body mass index (BMI) 25-29.9 kg/m² | 2 Participants |
| Body mass index (BMI) greater than 30 kg/m² | 4 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Number of participants who currently smoke | 1 Participants |
| Number of participants with hypertension | 4 Participants |
| Physical status as indicated by American Society of Anesthesiologists (ASA) Class ASA class I | 10 Participants |
| Physical status as indicated by American Society of Anesthesiologists (ASA) Class ASA class II | 9 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Region of Enrollment United States | 19 Participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 19 |
| other Total, other adverse events | 0 / 19 | 0 / 19 |
| serious Total, serious adverse events | 0 / 19 | 0 / 19 |
Outcome results
Primary
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.
Time frame: 60 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allogenic Amnion Chorion Membrane | Size of Wound Area | 0 micrometers (μm) | Standard Deviation 0 |
| Collagen Dressing | Size of Wound Area | 0 micrometers (μm) | Standard Deviation 0 |
Primary
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.
Time frame: 4 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allogenic Amnion Chorion Membrane | Size of Wound Area | 35.9 micrometers (μm) | Standard Deviation 12.2 |
| Collagen Dressing | Size of Wound Area | 37.3 micrometers (μm) | Standard Deviation 12.9 |
Primary
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.
Time frame: 10 days
Population: Data for this outcome were not collected for four in the allogenic amnion chorion membrane arm and four in the collagen dressing arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allogenic Amnion Chorion Membrane | Size of Wound Area | 22.9 micrometers (μm) | Standard Deviation 10.7 |
| Collagen Dressing | Size of Wound Area | 25.6 micrometers (μm) | Standard Deviation 10.2 |
Primary
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.
Time frame: 14 days
Population: Data for this outcome were not collected for one in the allogenic amnion chorion membrane arm and one in the collagen dressing arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allogenic Amnion Chorion Membrane | Size of Wound Area | 13.3 micrometers (μm) | Standard Deviation 9.1 |
| Collagen Dressing | Size of Wound Area | 14.1 micrometers (μm) | Standard Deviation 7.9 |
Primary
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.
Time frame: 21 days
Population: Data for this outcome were not collected for one in the allogenic amnion chorion membrane arm and one in the collagen dressing arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allogenic Amnion Chorion Membrane | Size of Wound Area | 2.8 micrometers (μm) | Standard Deviation 3.4 |
| Collagen Dressing | Size of Wound Area | 4.1 micrometers (μm) | Standard Deviation 4.1 |
Primary
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.
Time frame: 28 days
Population: Data for this outcome were not collected for one in the allogenic amnion chorion membrane arm and one in the collagen dressing arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allogenic Amnion Chorion Membrane | Size of Wound Area | 0 micrometers (μm) | Standard Deviation 0 |
| Collagen Dressing | Size of Wound Area | 0.25 micrometers (μm) | Standard Deviation 1 |
Primary
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.
Time frame: 45 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allogenic Amnion Chorion Membrane | Size of Wound Area | 0 micrometers (μm) | Standard Deviation 0 |
| Collagen Dressing | Size of Wound Area | 0 micrometers (μm) | Standard Deviation 0 |
Primary
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.
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allogenic Amnion Chorion Membrane | Size of Wound Area | 80 micrometers (μm) | Standard Deviation 0 |
| Collagen Dressing | Size of Wound Area | 80 micrometers (μm) | Standard Deviation 0 |
Secondary
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.
Time frame: 10 days
Population: Data for this outcome were not collected for one in the allogenic amnion chorion membrane arm and two in the collagen dressing arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allogenic Amnion Chorion Membrane | 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) | 4.4 blood vessels/field | Standard Deviation 2 |
| Collagen Dressing | 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) | 5.1 blood vessels/field | Standard Deviation 2 |
Secondary
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)
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allogenic Amnion Chorion Membrane | 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) | 4.9 blood vessels/field | Standard Deviation 1.9 |
| Collagen Dressing | 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) | 5.4 blood vessels/field | Standard Deviation 2.2 |
Secondary
Change in Percentage of Collagen Density in Wound Area as Assessed by Light Microscopy of Masson's Trichrome-stained Biopsy Sections
Time frame: baseline, 10 days
Population: Data for this outcome were not collected for one in the allogenic amnion chorion membrane arm and one in the collagen dressing arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allogenic Amnion Chorion Membrane | Change in Percentage of Collagen Density in Wound Area as Assessed by Light Microscopy of Masson's Trichrome-stained Biopsy Sections | 1.15 percentage of collagen density | Standard Deviation 2.41 |
| Collagen Dressing | Change in Percentage of Collagen Density in Wound Area as Assessed by Light Microscopy of Masson's Trichrome-stained Biopsy Sections | 3.38 percentage of collagen density | Standard Deviation 2.63 |
Secondary
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
Population: Data for this outcome measure were not collected.
Secondary
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.
Time frame: 10 days
Population: Data for this outcome were not collected for one in the allogenic amnion chorion membrane arm and two in the collagen dressing arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allogenic Amnion Chorion Membrane | Number of Neutrophil Cells as Assessed by Light Microscopy of Haematoxylin and Eosin (H&E)-Stained Biopsy Sections | 80 neutrophil cells/field | Standard Deviation 47.7 |
| Collagen Dressing | Number of Neutrophil Cells as Assessed by Light Microscopy of Haematoxylin and Eosin (H&E)-Stained Biopsy Sections | 88 neutrophil cells/field | Standard Deviation 35.8 |
Secondary
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.
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allogenic Amnion Chorion Membrane | Number of Neutrophil Cells as Assessed by Light Microscopy of Haematoxylin and Eosin (H&E)-Stained Biopsy Sections | 62.1 neutrophil cells | Standard Deviation 29.9 |
| Collagen Dressing | Number of Neutrophil Cells as Assessed by Light Microscopy of Haematoxylin and Eosin (H&E)-Stained Biopsy Sections | 65 neutrophil cells | Standard Deviation 22.6 |
Secondary
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.
Time frame: 28 days
Population: Data for this outcome were not collected for one in the allogenic amnion chorion membrane arm and one in the collagen dressing arm.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Allogenic Amnion Chorion Membrane | Number of Participants Stratified as Per the Degree of Epithelialization of Wound | no epithelialization | 0 Participants |
| Allogenic Amnion Chorion Membrane | Number of Participants Stratified as Per the Degree of Epithelialization of Wound | partial epithelialization | 0 Participants |
| Allogenic Amnion Chorion Membrane | Number of Participants Stratified as Per the Degree of Epithelialization of Wound | total epithelialization | 18 Participants |
| Collagen Dressing | Number of Participants Stratified as Per the Degree of Epithelialization of Wound | no epithelialization | 0 Participants |
| Collagen Dressing | Number of Participants Stratified as Per the Degree of Epithelialization of Wound | partial epithelialization | 0 Participants |
| Collagen Dressing | Number of Participants Stratified as Per the Degree of Epithelialization of Wound | total epithelialization | 18 Participants |
Secondary
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.
Time frame: 45 days
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Allogenic Amnion Chorion Membrane | Number of Participants Stratified as Per the Degree of Epithelialization of Wound | no epithelialization | 0 Participants |
| Allogenic Amnion Chorion Membrane | Number of Participants Stratified as Per the Degree of Epithelialization of Wound | partial epithelialization | 0 Participants |
| Allogenic Amnion Chorion Membrane | Number of Participants Stratified as Per the Degree of Epithelialization of Wound | total epithelialization | 19 Participants |
| Collagen Dressing | Number of Participants Stratified as Per the Degree of Epithelialization of Wound | no epithelialization | 0 Participants |
| Collagen Dressing | Number of Participants Stratified as Per the Degree of Epithelialization of Wound | partial epithelialization | 0 Participants |
| Collagen Dressing | Number of Participants Stratified as Per the Degree of Epithelialization of Wound | total epithelialization | 19 Participants |
Secondary
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.
Time frame: 60 days
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Allogenic Amnion Chorion Membrane | Number of Participants Stratified as Per the Degree of Epithelialization of Wound | no epithelialization | 0 Participants |
| Allogenic Amnion Chorion Membrane | Number of Participants Stratified as Per the Degree of Epithelialization of Wound | partial epithelialization | 0 Participants |
| Allogenic Amnion Chorion Membrane | Number of Participants Stratified as Per the Degree of Epithelialization of Wound | total epithelialization | 19 Participants |
| Collagen Dressing | Number of Participants Stratified as Per the Degree of Epithelialization of Wound | no epithelialization | 0 Participants |
| Collagen Dressing | Number of Participants Stratified as Per the Degree of Epithelialization of Wound | partial epithelialization | 0 Participants |
| Collagen Dressing | Number of Participants Stratified as Per the Degree of Epithelialization of Wound | total epithelialization | 19 Participants |
Secondary
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.
Time frame: 4 days
Population: Data for this outcome were not collected for one in the allogenic amnion chorion membrane arm.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Allogenic Amnion Chorion Membrane | Number of Participants Stratified as Per the Degree of Epithelialization of Wound | no epithelialization | 18 Participants |
| Allogenic Amnion Chorion Membrane | Number of Participants Stratified as Per the Degree of Epithelialization of Wound | partial epithelialization | 0 Participants |
| Allogenic Amnion Chorion Membrane | Number of Participants Stratified as Per the Degree of Epithelialization of Wound | total epithelialization | 0 Participants |
| Collagen Dressing | Number of Participants Stratified as Per the Degree of Epithelialization of Wound | no epithelialization | 19 Participants |
| Collagen Dressing | Number of Participants Stratified as Per the Degree of Epithelialization of Wound | partial epithelialization | 0 Participants |
| Collagen Dressing | Number of Participants Stratified as Per the Degree of Epithelialization of Wound | total epithelialization | 0 Participants |
Secondary
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.
Time frame: 10 days
Population: Data for this outcome were not collected for three in the allogenic amnion chorion membrane arm and four in the collagen dressing arm.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Allogenic Amnion Chorion Membrane | Number of Participants Stratified as Per the Degree of Epithelialization of Wound | no epithelialization | 0 Participants |
| Allogenic Amnion Chorion Membrane | Number of Participants Stratified as Per the Degree of Epithelialization of Wound | partial epithelialization | 15 Participants |
| Allogenic Amnion Chorion Membrane | Number of Participants Stratified as Per the Degree of Epithelialization of Wound | total epithelialization | 1 Participants |
| Collagen Dressing | Number of Participants Stratified as Per the Degree of Epithelialization of Wound | no epithelialization | 0 Participants |
| Collagen Dressing | Number of Participants Stratified as Per the Degree of Epithelialization of Wound | partial epithelialization | 15 Participants |
| Collagen Dressing | Number of Participants Stratified as Per the Degree of Epithelialization of Wound | total epithelialization | 0 Participants |
Secondary
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.
Time frame: 14 days
Population: Data for this outcome were not collected for one in the allogenic amnion chorion membrane arm and one in the collagen dressing arm.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Allogenic Amnion Chorion Membrane | Number of Participants Stratified as Per the Degree of Epithelialization of Wound | no epithelialization | 0 Participants |
| Allogenic Amnion Chorion Membrane | Number of Participants Stratified as Per the Degree of Epithelialization of Wound | partial epithelialization | 7 Participants |
| Allogenic Amnion Chorion Membrane | Number of Participants Stratified as Per the Degree of Epithelialization of Wound | total epithelialization | 11 Participants |
| Collagen Dressing | Number of Participants Stratified as Per the Degree of Epithelialization of Wound | no epithelialization | 0 Participants |
| Collagen Dressing | Number of Participants Stratified as Per the Degree of Epithelialization of Wound | partial epithelialization | 7 Participants |
| Collagen Dressing | Number of Participants Stratified as Per the Degree of Epithelialization of Wound | total epithelialization | 11 Participants |
Secondary
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.
Time frame: 21 days
Population: Data for this outcome were not collected for one in the allogenic amnion chorion membrane arm and seven in the collagen dressing arm.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Allogenic Amnion Chorion Membrane | Number of Participants Stratified as Per the Degree of Epithelialization of Wound | no epithelialization | 0 Participants |
| Allogenic Amnion Chorion Membrane | Number of Participants Stratified as Per the Degree of Epithelialization of Wound | partial epithelialization | 1 Participants |
| Allogenic Amnion Chorion Membrane | Number of Participants Stratified as Per the Degree of Epithelialization of Wound | total epithelialization | 17 Participants |
| Collagen Dressing | Number of Participants Stratified as Per the Degree of Epithelialization of Wound | no epithelialization | 0 Participants |
| Collagen Dressing | Number of Participants Stratified as Per the Degree of Epithelialization of Wound | partial epithelialization | 0 Participants |
| Collagen Dressing | Number of Participants Stratified as Per the Degree of Epithelialization of Wound | total epithelialization | 11 Participants |
Secondary
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.
Time frame: baseline
Population: Data were not collected at this time point for this outcome measure.
Secondary
Number of Participants With Haemostasis of Wound Area
Haemostasis is achieved when no bleeding of the wound site is actively seen.
Time frame: 45 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Allogenic Amnion Chorion Membrane | Number of Participants With Haemostasis of Wound Area | 19 Participants |
| Collagen Dressing | Number of Participants With Haemostasis of Wound Area | 19 Participants |
Secondary
Number of Participants With Haemostasis of Wound Area
Haemostasis is achieved when no bleeding of the wound site is actively seen.
Time frame: 60 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Allogenic Amnion Chorion Membrane | Number of Participants With Haemostasis of Wound Area | 19 Participants |
| Collagen Dressing | Number of Participants With Haemostasis of Wound Area | 19 Participants |
Secondary
Number of Participants With Haemostasis of Wound Area
Haemostasis is achieved when no bleeding of the wound site is actively seen.
Time frame: baseline
Population: Data were not collected at this time point for this outcome measure.
Secondary
Number of Participants With Haemostasis of Wound Area
Haemostasis is achieved when no bleeding of the wound site is actively seen.
Time frame: 4 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Allogenic Amnion Chorion Membrane | Number of Participants With Haemostasis of Wound Area | 19 Participants |
| Collagen Dressing | Number of Participants With Haemostasis of Wound Area | 19 Participants |
Secondary
Number of Participants With Haemostasis of Wound Area
Haemostasis is achieved when no bleeding of the wound site is actively seen.
Time frame: 10 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Allogenic Amnion Chorion Membrane | Number of Participants With Haemostasis of Wound Area | 18 Participants |
| Collagen Dressing | Number of Participants With Haemostasis of Wound Area | 19 Participants |
Secondary
Number of Participants With Haemostasis of Wound Area
Haemostasis is achieved when no bleeding of the wound site is actively seen.
Time frame: 14 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Allogenic Amnion Chorion Membrane | Number of Participants With Haemostasis of Wound Area | 18 Participants |
| Collagen Dressing | Number of Participants With Haemostasis of Wound Area | 18 Participants |
Secondary
Number of Participants With Haemostasis of Wound Area
Haemostasis is achieved when no bleeding of the wound site is actively seen.
Time frame: 21 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Allogenic Amnion Chorion Membrane | Number of Participants With Haemostasis of Wound Area | 19 Participants |
| Collagen Dressing | Number of Participants With Haemostasis of Wound Area | 19 Participants |
Secondary
Number of Participants With Haemostasis of Wound Area
Haemostasis is achieved when no bleeding of the wound site is actively seen.
Time frame: 28 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Allogenic Amnion Chorion Membrane | Number of Participants With Haemostasis of Wound Area | 19 Participants |
| Collagen Dressing | Number of Participants With Haemostasis of Wound Area | 19 Participants |
Secondary
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.
Time frame: 28 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allogenic Amnion Chorion Membrane | Pain as Assessed by a Visual Analogue Scale (VAS) | 0 units on a scale | Standard Deviation 0 |
| Collagen Dressing | Pain as Assessed by a Visual Analogue Scale (VAS) | 0 units on a scale | Standard Deviation 0 |
Secondary
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.
Time frame: 60 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allogenic Amnion Chorion Membrane | Pain as Assessed by a Visual Analogue Scale (VAS) | 0 units on a scale | Standard Deviation 0 |
| Collagen Dressing | Pain as Assessed by a Visual Analogue Scale (VAS) | 0 units on a scale | Standard Deviation 0 |
Secondary
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.
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allogenic Amnion Chorion Membrane | Pain as Assessed by a Visual Analogue Scale (VAS) | 7.89 units on a scale | Standard Deviation 2.13 |
| Collagen Dressing | Pain as Assessed by a Visual Analogue Scale (VAS) | 7.89 units on a scale | Standard Deviation 2.13 |
Secondary
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.
Time frame: 4 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allogenic Amnion Chorion Membrane | Pain as Assessed by a Visual Analogue Scale (VAS) | 4.42 units on a scale | Standard Deviation 1.57 |
| Collagen Dressing | Pain as Assessed by a Visual Analogue Scale (VAS) | 4.42 units on a scale | Standard Deviation 1.57 |
Secondary
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.
Time frame: 10 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allogenic Amnion Chorion Membrane | Pain as Assessed by a Visual Analogue Scale (VAS) | 1.63 units on a scale | Standard Deviation 2.31 |
| Collagen Dressing | Pain as Assessed by a Visual Analogue Scale (VAS) | 1.63 units on a scale | Standard Deviation 2.31 |
Secondary
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.
Time frame: 14 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allogenic Amnion Chorion Membrane | Pain as Assessed by a Visual Analogue Scale (VAS) | 0.53 units on a scale | Standard Deviation 1.26 |
| Collagen Dressing | Pain as Assessed by a Visual Analogue Scale (VAS) | 0.53 units on a scale | Standard Deviation 1.26 |
Secondary
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.
Time frame: 21 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allogenic Amnion Chorion Membrane | Pain as Assessed by a Visual Analogue Scale (VAS) | 0.32 units on a scale | Standard Deviation 1 |
| Collagen Dressing | Pain as Assessed by a Visual Analogue Scale (VAS) | 0.32 units on a scale | Standard Deviation 1 |
Secondary
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.
Time frame: 45 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allogenic Amnion Chorion Membrane | Pain as Assessed by a Visual Analogue Scale (VAS) | 0 units on a scale | Standard Deviation 0 |
| Collagen Dressing | Pain as Assessed by a Visual Analogue Scale (VAS) | 0 units on a scale | Standard Deviation 0 |
Secondary
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.
Time frame: 28 days
Population: Data for this outcome were not collected for three in the allogenic amnion chorion membrane arm and three in the collagen dressing arm.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Allogenic Amnion Chorion Membrane | Relative Difference in Color of Wound Site Compared to Adjacent Gingiva | obvious difference | 0 Participants |
| Allogenic Amnion Chorion Membrane | Relative Difference in Color of Wound Site Compared to Adjacent Gingiva | noticeable difference | 0 Participants |
| Allogenic Amnion Chorion Membrane | Relative Difference in Color of Wound Site Compared to Adjacent Gingiva | disguisable difference | 9 Participants |
| Allogenic Amnion Chorion Membrane | Relative Difference in Color of Wound Site Compared to Adjacent Gingiva | no noticeable difference | 7 Participants |
| Collagen Dressing | Relative Difference in Color of Wound Site Compared to Adjacent Gingiva | no noticeable difference | 2 Participants |
| Collagen Dressing | Relative Difference in Color of Wound Site Compared to Adjacent Gingiva | obvious difference | 0 Participants |
| Collagen Dressing | Relative Difference in Color of Wound Site Compared to Adjacent Gingiva | disguisable difference | 12 Participants |
| Collagen Dressing | Relative Difference in Color of Wound Site Compared to Adjacent Gingiva | noticeable difference | 2 Participants |
Secondary
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.
Time frame: 60 days
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Allogenic Amnion Chorion Membrane | Relative Difference in Color of Wound Site Compared to Adjacent Gingiva | obvious difference | 0 Participants |
| Allogenic Amnion Chorion Membrane | Relative Difference in Color of Wound Site Compared to Adjacent Gingiva | noticeable difference | 0 Participants |
| Allogenic Amnion Chorion Membrane | Relative Difference in Color of Wound Site Compared to Adjacent Gingiva | disguisable difference | 2 Participants |
| Allogenic Amnion Chorion Membrane | Relative Difference in Color of Wound Site Compared to Adjacent Gingiva | no noticeable difference | 17 Participants |
| Collagen Dressing | Relative Difference in Color of Wound Site Compared to Adjacent Gingiva | no noticeable difference | 16 Participants |
| Collagen Dressing | Relative Difference in Color of Wound Site Compared to Adjacent Gingiva | obvious difference | 0 Participants |
| Collagen Dressing | Relative Difference in Color of Wound Site Compared to Adjacent Gingiva | disguisable difference | 3 Participants |
| Collagen Dressing | Relative Difference in Color of Wound Site Compared to Adjacent Gingiva | noticeable difference | 0 Participants |
Secondary
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.
Time frame: 4 days
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Allogenic Amnion Chorion Membrane | Relative Difference in Color of Wound Site Compared to Adjacent Gingiva | obvious difference | 19 Participants |
| Allogenic Amnion Chorion Membrane | Relative Difference in Color of Wound Site Compared to Adjacent Gingiva | noticeable difference | 0 Participants |
| Allogenic Amnion Chorion Membrane | Relative Difference in Color of Wound Site Compared to Adjacent Gingiva | disguisable difference | 0 Participants |
| Allogenic Amnion Chorion Membrane | Relative Difference in Color of Wound Site Compared to Adjacent Gingiva | no noticeable difference | 0 Participants |
| Collagen Dressing | Relative Difference in Color of Wound Site Compared to Adjacent Gingiva | no noticeable difference | 0 Participants |
| Collagen Dressing | Relative Difference in Color of Wound Site Compared to Adjacent Gingiva | obvious difference | 19 Participants |
| Collagen Dressing | Relative Difference in Color of Wound Site Compared to Adjacent Gingiva | disguisable difference | 0 Participants |
| Collagen Dressing | Relative Difference in Color of Wound Site Compared to Adjacent Gingiva | noticeable difference | 0 Participants |
Secondary
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.
Time frame: 21 days
Population: Data for this outcome were not collected for one in the allogenic amnion chorion membrane arm and one in the collagen dressing arm.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Allogenic Amnion Chorion Membrane | Relative Difference in Color of Wound Site Compared to Adjacent Gingiva | obvious difference | 0 Participants |
| Allogenic Amnion Chorion Membrane | Relative Difference in Color of Wound Site Compared to Adjacent Gingiva | noticeable difference | 6 Participants |
| Allogenic Amnion Chorion Membrane | Relative Difference in Color of Wound Site Compared to Adjacent Gingiva | disguisable difference | 7 Participants |
| Allogenic Amnion Chorion Membrane | Relative Difference in Color of Wound Site Compared to Adjacent Gingiva | no noticeable difference | 5 Participants |
| Collagen Dressing | Relative Difference in Color of Wound Site Compared to Adjacent Gingiva | no noticeable difference | 1 Participants |
| Collagen Dressing | Relative Difference in Color of Wound Site Compared to Adjacent Gingiva | obvious difference | 0 Participants |
| Collagen Dressing | Relative Difference in Color of Wound Site Compared to Adjacent Gingiva | disguisable difference | 10 Participants |
| Collagen Dressing | Relative Difference in Color of Wound Site Compared to Adjacent Gingiva | noticeable difference | 7 Participants |
Secondary
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.
Time frame: 14 days
Population: Data for this outcome were not collected for one in the allogenic amnion chorion membrane arm and one in the collagen dressing arm.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Allogenic Amnion Chorion Membrane | Relative Difference in Color of Wound Site Compared to Adjacent Gingiva | disguisable difference | 1 Participants |
| Allogenic Amnion Chorion Membrane | Relative Difference in Color of Wound Site Compared to Adjacent Gingiva | obvious difference | 5 Participants |
| Allogenic Amnion Chorion Membrane | Relative Difference in Color of Wound Site Compared to Adjacent Gingiva | no noticeable difference | 0 Participants |
| Allogenic Amnion Chorion Membrane | Relative Difference in Color of Wound Site Compared to Adjacent Gingiva | noticeable difference | 12 Participants |
| Collagen Dressing | Relative Difference in Color of Wound Site Compared to Adjacent Gingiva | no noticeable difference | 0 Participants |
| Collagen Dressing | Relative Difference in Color of Wound Site Compared to Adjacent Gingiva | noticeable difference | 6 Participants |
| Collagen Dressing | Relative Difference in Color of Wound Site Compared to Adjacent Gingiva | disguisable difference | 2 Participants |
| Collagen Dressing | Relative Difference in Color of Wound Site Compared to Adjacent Gingiva | obvious difference | 10 Participants |
Secondary
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.
Time frame: 10 days
Population: Data for this outcome were not collected for four in the allogenic amnion chorion membrane arm and four in the collagen dressing arm.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Allogenic Amnion Chorion Membrane | Relative Difference in Color of Wound Site Compared to Adjacent Gingiva | obvious difference | 15 Participants |
| Allogenic Amnion Chorion Membrane | Relative Difference in Color of Wound Site Compared to Adjacent Gingiva | noticeable difference | 0 Participants |
| Allogenic Amnion Chorion Membrane | Relative Difference in Color of Wound Site Compared to Adjacent Gingiva | disguisable difference | 0 Participants |
| Allogenic Amnion Chorion Membrane | Relative Difference in Color of Wound Site Compared to Adjacent Gingiva | no noticeable difference | 0 Participants |
| Collagen Dressing | Relative Difference in Color of Wound Site Compared to Adjacent Gingiva | no noticeable difference | 0 Participants |
| Collagen Dressing | Relative Difference in Color of Wound Site Compared to Adjacent Gingiva | obvious difference | 15 Participants |
| Collagen Dressing | Relative Difference in Color of Wound Site Compared to Adjacent Gingiva | disguisable difference | 0 Participants |
| Collagen Dressing | Relative Difference in Color of Wound Site Compared to Adjacent Gingiva | noticeable difference | 0 Participants |
Secondary
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.
Time frame: baseline
Population: Data were not collected at this time point for this outcome measure.
Secondary
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.
Time frame: 45 days
Population: Data for this outcome were not collected for one in the allogenic amnion chorion membrane arm and one in the collagen dressing arm.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Allogenic Amnion Chorion Membrane | Relative Difference in Color of Wound Site Compared to Adjacent Gingiva | obvious difference | 0 Participants |
| Allogenic Amnion Chorion Membrane | Relative Difference in Color of Wound Site Compared to Adjacent Gingiva | noticeable difference | 0 Participants |
| Allogenic Amnion Chorion Membrane | Relative Difference in Color of Wound Site Compared to Adjacent Gingiva | disguisable difference | 4 Participants |
| Allogenic Amnion Chorion Membrane | Relative Difference in Color of Wound Site Compared to Adjacent Gingiva | no noticeable difference | 14 Participants |
| Collagen Dressing | Relative Difference in Color of Wound Site Compared to Adjacent Gingiva | no noticeable difference | 12 Participants |
| Collagen Dressing | Relative Difference in Color of Wound Site Compared to Adjacent Gingiva | obvious difference | 0 Participants |
| Collagen Dressing | Relative Difference in Color of Wound Site Compared to Adjacent Gingiva | disguisable difference | 6 Participants |
| Collagen Dressing | Relative Difference in Color of Wound Site Compared to Adjacent Gingiva | noticeable difference | 0 Participants |
Secondary
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.
Time frame: 45 days
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Allogenic Amnion Chorion Membrane | Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) | no loss of sensation | 19 Participants |
| Allogenic Amnion Chorion Membrane | Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) | mild/moderate loss of sensation | 0 Participants |
| Allogenic Amnion Chorion Membrane | Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) | severe loss of sensation | 0 Participants |
| Collagen Dressing | Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) | no loss of sensation | 19 Participants |
| Collagen Dressing | Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) | mild/moderate loss of sensation | 0 Participants |
| Collagen Dressing | Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) | severe loss of sensation | 0 Participants |
Secondary
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.
Time frame: 60 days
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Allogenic Amnion Chorion Membrane | Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) | no loss of sensation | 19 Participants |
| Allogenic Amnion Chorion Membrane | Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) | mild/moderate loss of sensation | 0 Participants |
| Allogenic Amnion Chorion Membrane | Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) | severe loss of sensation | 0 Participants |
| Collagen Dressing | Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) | no loss of sensation | 19 Participants |
| Collagen Dressing | Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) | mild/moderate loss of sensation | 0 Participants |
| Collagen Dressing | Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) | severe loss of sensation | 0 Participants |
Secondary
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.
Time frame: baseline
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Allogenic Amnion Chorion Membrane | Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) | no loss of sensation | 19 Participants |
| Allogenic Amnion Chorion Membrane | Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) | mild/moderate loss of sensation | 0 Participants |
| Allogenic Amnion Chorion Membrane | Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) | severe loss of sensation | 0 Participants |
| Collagen Dressing | Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) | no loss of sensation | 19 Participants |
| Collagen Dressing | Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) | mild/moderate loss of sensation | 0 Participants |
| Collagen Dressing | Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) | severe loss of sensation | 0 Participants |
Secondary
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.
Time frame: 4 days
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Allogenic Amnion Chorion Membrane | Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) | no loss of sensation | 19 Participants |
| Allogenic Amnion Chorion Membrane | Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) | mild/moderate loss of sensation | 0 Participants |
| Allogenic Amnion Chorion Membrane | Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) | severe loss of sensation | 0 Participants |
| Collagen Dressing | Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) | no loss of sensation | 19 Participants |
| Collagen Dressing | Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) | mild/moderate loss of sensation | 0 Participants |
| Collagen Dressing | Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) | severe loss of sensation | 0 Participants |
Secondary
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.
Time frame: 10 days
Population: Data for this outcome were not collected for four in the allogenic amnion chorion membrane arm and four in the collagen dressing arm.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Allogenic Amnion Chorion Membrane | Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) | no loss of sensation | 15 Participants |
| Allogenic Amnion Chorion Membrane | Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) | mild/moderate loss of sensation | 0 Participants |
| Allogenic Amnion Chorion Membrane | Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) | severe loss of sensation | 0 Participants |
| Collagen Dressing | Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) | no loss of sensation | 15 Participants |
| Collagen Dressing | Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) | mild/moderate loss of sensation | 0 Participants |
| Collagen Dressing | Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) | severe loss of sensation | 0 Participants |
Secondary
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.
Time frame: 14 days
Population: Data for this outcome were not collected for one in the allogenic amnion chorion membrane arm and one in the collagen dressing arm.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Allogenic Amnion Chorion Membrane | Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) | no loss of sensation | 18 Participants |
| Allogenic Amnion Chorion Membrane | Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) | mild/moderate loss of sensation | 0 Participants |
| Allogenic Amnion Chorion Membrane | Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) | severe loss of sensation | 0 Participants |
| Collagen Dressing | Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) | no loss of sensation | 18 Participants |
| Collagen Dressing | Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) | mild/moderate loss of sensation | 0 Participants |
| Collagen Dressing | Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) | severe loss of sensation | 0 Participants |
Secondary
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.
Time frame: 21 days
Population: Data for this outcome were not collected for one in the allogenic amnion chorion membrane arm and one in the collagen dressing arm.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Allogenic Amnion Chorion Membrane | Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) | no loss of sensation | 18 Participants |
| Allogenic Amnion Chorion Membrane | Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) | mild/moderate loss of sensation | 0 Participants |
| Allogenic Amnion Chorion Membrane | Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) | severe loss of sensation | 0 Participants |
| Collagen Dressing | Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) | no loss of sensation | 18 Participants |
| Collagen Dressing | Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) | mild/moderate loss of sensation | 0 Participants |
| Collagen Dressing | Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) | severe loss of sensation | 0 Participants |
Secondary
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.
Time frame: 28 days
Population: Data for this outcome were not collected for one in the allogenic amnion chorion membrane arm and one in the collagen dressing arm.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Allogenic Amnion Chorion Membrane | Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) | no loss of sensation | 18 Participants |
| Allogenic Amnion Chorion Membrane | Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) | mild/moderate loss of sensation | 0 Participants |
| Allogenic Amnion Chorion Membrane | Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) | severe loss of sensation | 0 Participants |
| Collagen Dressing | Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) | no loss of sensation | 18 Participants |
| Collagen Dressing | Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) | mild/moderate loss of sensation | 0 Participants |
| Collagen Dressing | Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS) | severe loss of sensation | 0 Participants |
Secondary
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.
Time frame: 10 days
Population: Data for this outcome were not collected for one in the allogenic amnion chorion membrane arm and two in the collagen dressing arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allogenic Amnion Chorion Membrane | Thickness of the Epithelium as Assessed by Light Microscopy of Haematoxylin and Eosin (H&E)-Stained Biopsy Sections | 339.6 micrometers (μm) | Standard Deviation 94.4 |
| Collagen Dressing | Thickness of the Epithelium as Assessed by Light Microscopy of Haematoxylin and Eosin (H&E)-Stained Biopsy Sections | 339.3 micrometers (μm) | Standard Deviation 118.6 |
Secondary
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.
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allogenic Amnion Chorion Membrane | Thickness of the Epithelium as Assessed by Light Microscopy of Haematoxylin and Eosin (H&E)-Stained Biopsy Sections | 302.2 micrometers (μm) | Standard Deviation 95.2 |
| Collagen Dressing | Thickness of the Epithelium as Assessed by Light Microscopy of Haematoxylin and Eosin (H&E)-Stained Biopsy Sections | 291 micrometers (μm) | Standard Deviation 79.7 |
Secondary
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.
Time frame: baseline
Population: There is not enough usable data collected for any participant to summarize and report this outcome measure accurately.
Secondary
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.
Time frame: 4 days
Population: There is not enough usable data collected for any participant to summarize and report this outcome measure accurately.
Secondary
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.
Time frame: 10 days
Population: There is not enough usable data collected for any participant to summarize and report this outcome measure accurately.
Secondary
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.
Time frame: 14 days
Population: There is not enough usable data collected for any participant to summarize and report this outcome measure accurately.
Secondary
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.
Time frame: 21 days
Population: There is not enough usable data collected for any participant to summarize and report this outcome measure accurately.
Secondary
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.
Time frame: 45 days
Population: There is not enough usable data collected for any participant to summarize and report this outcome measure accurately.
Secondary
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.
Time frame: 28 days
Population: There is not enough usable data collected for any participant to summarize and report this outcome measure accurately.
Secondary
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.
Time frame: 60 days
Population: There is not enough usable data collected for any participant to summarize and report this outcome measure accurately.