| 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. | | Posted | | Mean | Standard Deviation | micrometers (μm) | | baseline | | | | ID | Title | Description |
|---|
| OG000 | 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. 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. | | OG001 | Collagen Dressing | Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery. |
| | | Title | Denominators | Categories |
|---|
| | |
| |
| 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. | | Posted | | Mean | Standard Deviation | micrometers (μm) | | 4 days | | | | ID | Title | Description |
|---|
| OG000 | 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. 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. | | OG001 | Collagen Dressing | Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery. |
| |
| 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. | Data for this outcome were not collected for four in the allogenic amnion chorion membrane arm and four in the collagen dressing arm. | Posted | | Mean | Standard Deviation | micrometers (μm) | | 10 days | | | | ID | Title | Description |
|---|
| OG000 | 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. 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. | | OG001 | Collagen Dressing | Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery. |
| |
| 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. | Data for this outcome were not collected for one in the allogenic amnion chorion membrane arm and one in the collagen dressing arm. | Posted | | Mean | Standard Deviation | micrometers (μm) | | 14 days | | | | ID | Title | Description |
|---|
| OG000 | 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. 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. | | OG001 | Collagen Dressing | Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery. |
| |
| 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. | Data for this outcome were not collected for one in the allogenic amnion chorion membrane arm and one in the collagen dressing arm. | Posted | | Mean | Standard Deviation | micrometers (μm) | | 21 days | | | | ID | Title | Description |
|---|
| OG000 | 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. 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. | | OG001 | Collagen Dressing | Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery. |
| |
| 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. | Data for this outcome were not collected for one in the allogenic amnion chorion membrane arm and one in the collagen dressing arm. | Posted | | Mean | Standard Deviation | micrometers (μm) | | 28 days | | | | ID | Title | Description |
|---|
| OG000 | 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. 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. | | OG001 | Collagen Dressing | Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery. |
| |
| 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. | | Posted | | Mean | Standard Deviation | micrometers (μm) | | 45 days | | | | ID | Title | Description |
|---|
| OG000 | 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. 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. | | OG001 | Collagen Dressing | Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery. |
| |
| 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. | | Posted | | Mean | Standard Deviation | micrometers (μm) | | 60 days | | | | ID | Title | Description |
|---|
| OG000 | 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. 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. | | OG001 | Collagen Dressing | Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery. |
| |
| 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. | Data were not collected at this time point for this outcome measure. | Posted | | | | | | baseline | | | | ID | Title | Description |
|---|
| OG000 | 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. 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. | | OG001 | Collagen Dressing | Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery. |
| |
| 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. | Data for this outcome were not collected for one in the allogenic amnion chorion membrane arm. | Posted | | Count of Participants | | Participants | | 4 days | | | | ID | Title | Description |
|---|
| OG000 | 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. 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. | | OG001 | Collagen Dressing | Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery. |
| |
| 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. | Data for this outcome were not collected for three in the allogenic amnion chorion membrane arm and four in the collagen dressing arm. | Posted | | Count of Participants | | Participants | | 10 days | | | | ID | Title | Description |
|---|
| OG000 | 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. 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. | | OG001 | Collagen Dressing | Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery. |
| |
| 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. | Data for this outcome were not collected for one in the allogenic amnion chorion membrane arm and one in the collagen dressing arm. | Posted | | Count of Participants | | Participants | | 14 days | | | | ID | Title | Description |
|---|
| OG000 | 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. 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. | | OG001 | Collagen Dressing | Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery. |
| |
| 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. | Data for this outcome were not collected for one in the allogenic amnion chorion membrane arm and seven in the collagen dressing arm. | Posted | | Count of Participants | | Participants | | 21 days | | | | ID | Title | Description |
|---|
| OG000 | 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. 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. | | OG001 | Collagen Dressing | Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery. |
| |
| 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. | Data for this outcome were not collected for one in the allogenic amnion chorion membrane arm and one in the collagen dressing arm. | Posted | | Count of Participants | | Participants | | 28 days | | | | ID | Title | Description |
|---|
| OG000 | 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. 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. | | OG001 | Collagen Dressing | Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery. |
| |
| 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. | | Posted | | Count of Participants | | Participants | | 45 days | | | | ID | Title | Description |
|---|
| OG000 | 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. 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. | | OG001 | Collagen Dressing | Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery. |
| |
| 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. | | Posted | | Count of Participants | | Participants | | 60 days | | | | ID | Title | Description |
|---|
| OG000 | 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. 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. | | OG001 | Collagen Dressing | Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery. |
| |
| 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. | Data were not collected at this time point for this outcome measure. | Posted | | | | | | baseline | | | | ID | Title | Description |
|---|
| OG000 | 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. 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. | | OG001 | Collagen Dressing | Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery. |
| |
| 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. | | Posted | | Count of Participants | | Participants | | 4 days | | | | ID | Title | Description |
|---|
| OG000 | 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. 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. | | OG001 | Collagen Dressing | Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery. |
| |
| 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. | Data for this outcome were not collected for four in the allogenic amnion chorion membrane arm and four in the collagen dressing arm. | Posted | | Count of Participants | | Participants | | 10 days | | | | ID | Title | Description |
|---|
| OG000 | 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. 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. | | OG001 | Collagen Dressing | Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery. |
| |
| 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. | Data for this outcome were not collected for one in the allogenic amnion chorion membrane arm and one in the collagen dressing arm. | Posted | | Count of Participants | | Participants | | 14 days | | | | ID | Title | Description |
|---|
| OG000 | 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. 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. | | OG001 | Collagen Dressing | Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery. |
| |
| 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. | Data for this outcome were not collected for one in the allogenic amnion chorion membrane arm and one in the collagen dressing arm. | Posted | | Count of Participants | | Participants | | 21 days | | | | ID | Title | Description |
|---|
| OG000 | 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. 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. | | OG001 | Collagen Dressing | Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery. |
| |
| 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. | Data for this outcome were not collected for three in the allogenic amnion chorion membrane arm and three in the collagen dressing arm. | Posted | | Count of Participants | | Participants | | 28 days | | | | ID | Title | Description |
|---|
| OG000 | 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. 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. | | OG001 | Collagen Dressing | Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery. |
| |
| 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. | Data for this outcome were not collected for one in the allogenic amnion chorion membrane arm and one in the collagen dressing arm. | Posted | | Count of Participants | | Participants | | 45 days | | | | ID | Title | Description |
|---|
| OG000 | 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. 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. | | OG001 | Collagen Dressing | Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery. |
| |
| 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. | | Posted | | Count of Participants | | Participants | | 60 days | | | | ID | Title | Description |
|---|
| OG000 | 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. 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. | | OG001 | Collagen Dressing | Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery. |
| |
| Secondary | Number of Participants With Haemostasis of Wound Area | Haemostasis is achieved when no bleeding of the wound site is actively seen. | Data were not collected at this time point for this outcome measure. | Posted | | | | | | baseline | | | | ID | Title | Description |
|---|
| OG000 | 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. 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. | | OG001 | Collagen Dressing | Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery. |
| |
| Secondary | Number of Participants With Haemostasis of Wound Area | Haemostasis is achieved when no bleeding of the wound site is actively seen. | | Posted | | Count of Participants | | Participants | | 4 days | | | | ID | Title | Description |
|---|
| OG000 | 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. 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. | | OG001 | Collagen Dressing | Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery. |
| |
| Secondary | Number of Participants With Haemostasis of Wound Area | Haemostasis is achieved when no bleeding of the wound site is actively seen. | | Posted | | Count of Participants | | Participants | | 10 days | | | | ID | Title | Description |
|---|
| OG000 | 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. 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. | | OG001 | Collagen Dressing | Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery. |
| |
| Secondary | Number of Participants With Haemostasis of Wound Area | Haemostasis is achieved when no bleeding of the wound site is actively seen. | | Posted | | Count of Participants | | Participants | | 14 days | | | | ID | Title | Description |
|---|
| OG000 | 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. 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. | | OG001 | Collagen Dressing | Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery. |
| |
| Secondary | Number of Participants With Haemostasis of Wound Area | Haemostasis is achieved when no bleeding of the wound site is actively seen. | | Posted | | Count of Participants | | Participants | | 21 days | | | | ID | Title | Description |
|---|
| OG000 | 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. 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. | | OG001 | Collagen Dressing | Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery. |
| |
| Secondary | Number of Participants With Haemostasis of Wound Area | Haemostasis is achieved when no bleeding of the wound site is actively seen. | | Posted | | Count of Participants | | Participants | | 28 days | | | | ID | Title | Description |
|---|
| OG000 | 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. 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. | | OG001 | Collagen Dressing | Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery. |
| |
| Secondary | Number of Participants With Haemostasis of Wound Area | Haemostasis is achieved when no bleeding of the wound site is actively seen. | | Posted | | Count of Participants | | Participants | | 45 days | | | | ID | Title | Description |
|---|
| OG000 | 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. 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. | | OG001 | Collagen Dressing | Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery. |
| |
| Secondary | Number of Participants With Haemostasis of Wound Area | Haemostasis is achieved when no bleeding of the wound site is actively seen. | | Posted | | Count of Participants | | Participants | | 60 days | | | | ID | Title | Description |
|---|
| OG000 | 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. 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. | | OG001 | Collagen Dressing | Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery. |
| |
| 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. | | Posted | | Mean | Standard Deviation | units on a scale | | baseline | | | | ID | Title | Description |
|---|
| OG000 | 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. 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. | | OG001 | Collagen Dressing | Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery. |
| |
| 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. | | Posted | | Mean | Standard Deviation | units on a scale | | 4 days | | | | ID | Title | Description |
|---|
| OG000 | 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. 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. | | OG001 | Collagen Dressing | Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery. |
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| 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. | | Posted | | Mean | Standard Deviation | units on a scale | | 10 days | | | | ID | Title | Description |
|---|
| OG000 | 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. 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. | | OG001 | Collagen Dressing | Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery. |
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| 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. | | Posted | | Mean | Standard Deviation | units on a scale | | 14 days | | | | ID | Title | Description |
|---|
| OG000 | 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. 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. | | OG001 | Collagen Dressing | Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery. |
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| 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. | | Posted | | Mean | Standard Deviation | units on a scale | | 21 days | | | | ID | Title | Description |
|---|
| OG000 | 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. 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. | | OG001 | Collagen Dressing | Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery. |
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| 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. | | Posted | | Mean | Standard Deviation | units on a scale | | 28 days | | | | ID | Title | Description |
|---|
| OG000 | 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. 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. | | OG001 | Collagen Dressing | Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery. |
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| 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. | | Posted | | Mean | Standard Deviation | units on a scale | | 45 days | | | | ID | Title | Description |
|---|
| OG000 | 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. 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. | | OG001 | Collagen Dressing | Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery. |
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| 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. | | Posted | | Mean | Standard Deviation | units on a scale | | 60 days | | | | ID | Title | Description |
|---|
| OG000 | 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. 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. | | OG001 | Collagen Dressing | Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery. |
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| 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. | | Posted | | Count of Participants | | Participants | | baseline | | | | ID | Title | Description |
|---|
| OG000 | 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. 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. | | OG001 | Collagen Dressing | Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery. |
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| 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. | | Posted | | Count of Participants | | Participants | | 4 days | | | | ID | Title | Description |
|---|
| OG000 | 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. 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. | | OG001 | Collagen Dressing | Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery. |
| |
| 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. | Data for this outcome were not collected for four in the allogenic amnion chorion membrane arm and four in the collagen dressing arm. | Posted | | Count of Participants | | Participants | | 10 days | | | | ID | Title | Description |
|---|
| OG000 | 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. 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. | | OG001 | Collagen Dressing | Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery. |
| |
| 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. | Data for this outcome were not collected for one in the allogenic amnion chorion membrane arm and one in the collagen dressing arm. | Posted | | Count of Participants | | Participants | | 14 days | | | | ID | Title | Description |
|---|
| OG000 | 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. 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. | | OG001 | Collagen Dressing | Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery. |
| |
| 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. | Data for this outcome were not collected for one in the allogenic amnion chorion membrane arm and one in the collagen dressing arm. | Posted | | Count of Participants | | Participants | | 21 days | | | | ID | Title | Description |
|---|
| OG000 | 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. 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. | | OG001 | Collagen Dressing | Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery. |
| |
| 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. | Data for this outcome were not collected for one in the allogenic amnion chorion membrane arm and one in the collagen dressing arm. | Posted | | Count of Participants | | Participants | | 28 days | | | | ID | Title | Description |
|---|
| OG000 | 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. 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. | | OG001 | Collagen Dressing | Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery. |
| |
| 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. | | Posted | | Count of Participants | | Participants | | 45 days | | | | ID | Title | Description |
|---|
| OG000 | 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. 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. | | OG001 | Collagen Dressing | Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery. |
| |
| 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. | | Posted | | Count of Participants | | Participants | | 60 days | | | | ID | Title | Description |
|---|
| OG000 | 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. 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. | | OG001 | Collagen Dressing | Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery. |
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| 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. | There is not enough usable data collected for any participant to summarize and report this outcome measure accurately. | Posted | | | | | | baseline | | | | ID | Title | Description |
|---|
| OG000 | 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. 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. | | OG001 | Collagen Dressing | Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery. |
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| 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. | There is not enough usable data collected for any participant to summarize and report this outcome measure accurately. | Posted | | | | | | 4 days | | | | ID | Title | Description |
|---|
| OG000 | 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. 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. | | OG001 | Collagen Dressing | Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery. |
| |
| 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. | There is not enough usable data collected for any participant to summarize and report this outcome measure accurately. | Posted | | | | | | 10 days | | | | ID | Title | Description |
|---|
| OG000 | 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. 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. | | OG001 | Collagen Dressing | Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery. |
| |
| 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. | There is not enough usable data collected for any participant to summarize and report this outcome measure accurately. | Posted | | | | | | 14 days | | | | ID | Title | Description |
|---|
| OG000 | 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. 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. | | OG001 | Collagen Dressing | Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery. |
| |
| 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. | There is not enough usable data collected for any participant to summarize and report this outcome measure accurately. | Posted | | | | | | 21 days | | | | ID | Title | Description |
|---|
| OG000 | 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. 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. | | OG001 | Collagen Dressing | Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery. |
| |
| 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. | There is not enough usable data collected for any participant to summarize and report this outcome measure accurately. | Posted | | | | | | 28 days | | | | ID | Title | Description |
|---|
| OG000 | 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. 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. | | OG001 | Collagen Dressing | Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery. |
| |
| 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. | There is not enough usable data collected for any participant to summarize and report this outcome measure accurately. | Posted | | | | | | 45 days | | | | ID | Title | Description |
|---|
| OG000 | 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. 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. | | OG001 | Collagen Dressing | Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery. |
| |
| 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. | There is not enough usable data collected for any participant to summarize and report this outcome measure accurately. | Posted | | | | | | 60 days | | | | ID | Title | Description |
|---|
| OG000 | 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. 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. | | OG001 | Collagen Dressing | Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery. |
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| Secondary | Clinician's Feedback on the Wound Dressing Material as Assessed by a Questionnaire | | Data for this outcome measure were not collected. | Posted | | | | | | at the time of placement of the wound dressing material | | | | ID | Title | Description |
|---|
| OG000 | 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. 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. | | OG001 | Collagen Dressing | Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery. |
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| 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. | | Posted | | Mean | Standard Deviation | neutrophil cells | | baseline | | | | ID | Title | Description |
|---|
| OG000 | 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. 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. | | OG001 | Collagen Dressing | Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery. |
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| 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. | Data for this outcome were not collected for one in the allogenic amnion chorion membrane arm and two in the collagen dressing arm. | Posted | | Mean | Standard Deviation | neutrophil cells/field | | 10 days | | | | ID | Title | Description |
|---|
| OG000 | 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. 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. | | OG001 | Collagen Dressing | Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery. |
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| Secondary | Change in Percentage of Collagen Density in Wound Area as Assessed by Light Microscopy of Masson's Trichrome-stained Biopsy Sections | | Data for this outcome were not collected for one in the allogenic amnion chorion membrane arm and one in the collagen dressing arm. | Posted | | Mean | Standard Deviation | percentage of collagen density | | baseline, 10 days | | | | ID | Title | Description |
|---|
| OG000 | 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. 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. | | OG001 | Collagen Dressing | Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery. |
| |
| 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. | | Posted | | Mean | Standard Deviation | micrometers (μm) | | baseline | | | | ID | Title | Description |
|---|
| OG000 | 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. 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. | | OG001 | Collagen Dressing | Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery. |
| |
| 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. | Data for this outcome were not collected for one in the allogenic amnion chorion membrane arm and two in the collagen dressing arm. | Posted | | Mean | Standard Deviation | micrometers (μm) | | 10 days | | | | ID | Title | Description |
|---|
| OG000 | 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. 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. | | OG001 | Collagen Dressing | Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery. |
| |
| 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) | | | Posted | | Mean | Standard Deviation | blood vessels/field | | baseline | | | | ID | Title | Description |
|---|
| OG000 | 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. 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. | | OG001 | Collagen Dressing | Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery. |
| |
| 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. | Data for this outcome were not collected for one in the allogenic amnion chorion membrane arm and two in the collagen dressing arm. | Posted | | Mean | Standard Deviation | blood vessels/field | | 10 days | | | | ID | Title | Description |
|---|
| OG000 | 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. 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. | | OG001 | Collagen Dressing | Collagen dressing is used to cover wounds in dental surgery. Collagen dressing: Collagen dressing is used to cover wounds in dental surgery. |
| |