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Clinical and Histological Outcomes of Allogenic Amnion Chorion Membrane in the Healing of Free Gingival Graft Donor Site
NA trial testing Allogenic amnion chorion membrane in Palatal Wound in 19 participants. Completed in 17 January 2020.
| Lead sponsor | The University of Texas Health Science Center, Houston |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 19 |
| Start date | 3 October 2016 |
| Primary completion | 17 January 2020 |
| Estimated completion | 17 January 2020 |
| Sites | 1 location across United States |
The University of Texas Health Science Center, Houston
18 and older, any sex, with Palatal Wound. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Allogenic Amnion Chorion Membrane | 80 | ± 0 |
| Collagen Dressing | 80 | ± 0 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Allogenic Amnion Chorion Membrane | 35.9 | ± 12.2 |
| Collagen Dressing | 37.3 | ± 12.9 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Allogenic Amnion Chorion Membrane | 22.9 | ± 10.7 |
| Collagen Dressing | 25.6 | ± 10.2 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Allogenic Amnion Chorion Membrane | 13.3 | ± 9.1 |
| Collagen Dressing | 14.1 | ± 7.9 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Allogenic Amnion Chorion Membrane | 2.8 | ± 3.4 |
| Collagen Dressing | 4.1 | ± 4.1 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Allogenic Amnion Chorion Membrane | 0 | ± 0 |
| Collagen Dressing | 0.25 | ± 1.0 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Allogenic Amnion Chorion Membrane | 0 | ± 0 |
| Collagen Dressing | 0 | ± 0 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Allogenic Amnion Chorion Membrane | 0 | ± 0 |
| Collagen Dressing | 0 | ± 0 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Allogenic Amnion Chorion Membrane | 18 | |
| Collagen Dressing | 19 | |
| Allogenic Amnion Chorion Membrane | 0 | |
| Collagen Dressing | 0 | |
| Allogenic Amnion Chorion Membrane | 0 | |
| Collagen Dressing | 0 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Allogenic Amnion Chorion Membrane | 0 | |
| Collagen Dressing | 0 | |
| Allogenic Amnion Chorion Membrane | 15 | |
| Collagen Dressing | 15 | |
| Allogenic Amnion Chorion Membrane | 1 | |
| Collagen Dressing | 0 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Allogenic Amnion Chorion Membrane | 0 | |
| Collagen Dressing | 0 | |
| Allogenic Amnion Chorion Membrane | 7 | |
| Collagen Dressing | 7 | |
| Allogenic Amnion Chorion Membrane | 11 | |
| Collagen Dressing | 11 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Allogenic Amnion Chorion Membrane | 0 | |
| Collagen Dressing | 0 | |
| Allogenic Amnion Chorion Membrane | 1 | |
| Collagen Dressing | 0 | |
| Allogenic Amnion Chorion Membrane | 17 | |
| Collagen Dressing | 11 |
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).
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing