Clinical and Histological Outcomes of Allogenic Amnion Chorion Membrane in the Healing of Free Gingival Graft Donor Site
2021년 12월 17일 업데이트: Chun-Teh Lee, The University of Texas Health Science Center, Houston
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).
연구 개요
연구 유형
중재적
등록 (실제)
19
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Texas
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Houston, Texas, 미국, 77030
- The University of Texas Health Science Center at Houston
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
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Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery.
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활성 비교기: Collagen dressing
Collagen dressing is used to cover wounds in dental surgery.
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Collagen dressing is used to cover wounds in dental surgery.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Size of Wound Area
기간: baseline
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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.
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baseline
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Size of Wound Area
기간: 4 days
|
The wound area will be assessed by means of a clinical picture.
The picture will be taken with an angulation perpendicular to the wound.
A periodontal probe will be placed by the wound as a reference scale.
Wound area is defined as the area without epithelization.
The wound area on the picture will be measured by ImageJ.
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4 days
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Size of Wound Area
기간: 10 days
|
The wound area will be assessed by means of a clinical picture.
The picture will be taken with an angulation perpendicular to the wound.
A periodontal probe will be placed by the wound as a reference scale.
Wound area is defined as the area without epithelization.
The wound area on the picture will be measured by ImageJ.
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10 days
|
|
Size of Wound Area
기간: 14 days
|
The wound area will be assessed by means of a clinical picture.
The picture will be taken with an angulation perpendicular to the wound.
A periodontal probe will be placed by the wound as a reference scale.
Wound area is defined as the area without epithelization.
The wound area on the picture will be measured by ImageJ.
|
14 days
|
|
Size of Wound Area
기간: 21 days
|
The wound area will be assessed by means of a clinical picture.
The picture will be taken with an angulation perpendicular to the wound.
A periodontal probe will be placed by the wound as a reference scale.
Wound area is defined as the area without epithelization.
The wound area on the picture will be measured by ImageJ.
|
21 days
|
|
Size of Wound Area
기간: 28 days
|
The wound area will be assessed by means of a clinical picture.
The picture will be taken with an angulation perpendicular to the wound.
A periodontal probe will be placed by the wound as a reference scale.
Wound area is defined as the area without epithelization.
The wound area on the picture will be measured by ImageJ.
|
28 days
|
|
Size of Wound Area
기간: 45 days
|
The wound area will be assessed by means of a clinical picture.
The picture will be taken with an angulation perpendicular to the wound.
A periodontal probe will be placed by the wound as a reference scale.
Wound area is defined as the area without epithelization.
The wound area on the picture will be measured by ImageJ.
|
45 days
|
|
Size of Wound Area
기간: 60 days
|
The wound area will be assessed by means of a clinical picture.
The picture will be taken with an angulation perpendicular to the wound.
A periodontal probe will be placed by the wound as a reference scale.
Wound area is defined as the area without epithelization.
The wound area on the picture will be measured by ImageJ.
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60 days
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of Participants Stratified as Per the Degree of Epithelialization of Wound
기간: baseline
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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.
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baseline
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Number of Participants Stratified as Per the Degree of Epithelialization of Wound
기간: 4 days
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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.
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4 days
|
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Number of Participants Stratified as Per the Degree of Epithelialization of Wound
기간: 10 days
|
Epithelialization is measured by means of bubble formation after dripping hydrogen peroxide (3%) to the wound surface.
Less bubbles indicate greater epithelialization, and epithelialization will be ranked as total, partial or none.
|
10 days
|
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Number of Participants Stratified as Per the Degree of Epithelialization of Wound
기간: 14 days
|
Epithelialization is measured by means of bubble formation after dripping hydrogen peroxide (3%) to the wound surface.
Less bubbles indicate greater epithelialization, and epithelialization will be ranked as total, partial or none.
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14 days
|
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Number of Participants Stratified as Per the Degree of Epithelialization of Wound
기간: 21 days
|
Epithelialization is measured by means of bubble formation after dripping hydrogen peroxide (3%) to the wound surface.
Less bubbles indicate greater epithelialization, and epithelialization will be ranked as total, partial or none.
|
21 days
|
|
Number of Participants Stratified as Per the Degree of Epithelialization of Wound
기간: 28 days
|
Epithelialization is measured by means of bubble formation after dripping hydrogen peroxide (3%) to the wound surface.
Less bubbles indicate greater epithelialization, and epithelialization will be ranked as total, partial or none.
|
28 days
|
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Number of Participants Stratified as Per the Degree of Epithelialization of Wound
기간: 45 days
|
Epithelialization is measured by means of bubble formation after dripping hydrogen peroxide (3%) to the wound surface.
Less bubbles indicate greater epithelialization, and epithelialization will be ranked as total, partial or none.
|
45 days
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Number of Participants Stratified as Per the Degree of Epithelialization of Wound
기간: 60 days
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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.
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60 days
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Relative Difference in Color of Wound Site Compared to Adjacent Gingiva
기간: baseline
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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.
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baseline
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Relative Difference in Color of Wound Site Compared to Adjacent Gingiva
기간: 4 days
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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.
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4 days
|
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Relative Difference in Color of Wound Site Compared to Adjacent Gingiva
기간: 10 days
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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.
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10 days
|
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Relative Difference in Color of Wound Site Compared to Adjacent Gingiva
기간: 14 days
|
The color of wound site will be compared to the adjacent gingiva by using a 4-point scale: 1. Obvious difference; 2. Noticeable difference; 3. Disguisable difference; or 4. No noticeable difference in comparison with adjacent gingiva.
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14 days
|
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Relative Difference in Color of Wound Site Compared to Adjacent Gingiva
기간: 21 days
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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.
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21 days
|
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Relative Difference in Color of Wound Site Compared to Adjacent Gingiva
기간: 28 days
|
The color of wound site will be compared to the adjacent gingiva by using a 4-point scale: 1. Obvious difference; 2. Noticeable difference; 3. Disguisable difference; or 4. No noticeable difference in comparison with adjacent gingiva.
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28 days
|
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Relative Difference in Color of Wound Site Compared to Adjacent Gingiva
기간: 45 days
|
The color of wound site will be compared to the adjacent gingiva by using a 4-point scale: 1. Obvious difference; 2. Noticeable difference; 3. Disguisable difference; or 4. No noticeable difference in comparison with adjacent gingiva.
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45 days
|
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Relative Difference in Color of Wound Site Compared to Adjacent Gingiva
기간: 60 days
|
The color of wound site will be compared to the adjacent gingiva by using a 4-point scale: 1. Obvious difference; 2. Noticeable difference; 3. Disguisable difference; or 4. No noticeable difference in comparison with adjacent gingiva.
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60 days
|
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Number of Participants With Haemostasis of Wound Area
기간: baseline
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Haemostasis is achieved when no bleeding of the wound site is actively seen.
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baseline
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Number of Participants With Haemostasis of Wound Area
기간: 4 days
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Haemostasis is achieved when no bleeding of the wound site is actively seen.
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4 days
|
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Number of Participants With Haemostasis of Wound Area
기간: 10 days
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Haemostasis is achieved when no bleeding of the wound site is actively seen.
|
10 days
|
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Number of Participants With Haemostasis of Wound Area
기간: 14 days
|
Haemostasis is achieved when no bleeding of the wound site is actively seen.
|
14 days
|
|
Number of Participants With Haemostasis of Wound Area
기간: 21 days
|
Haemostasis is achieved when no bleeding of the wound site is actively seen.
|
21 days
|
|
Number of Participants With Haemostasis of Wound Area
기간: 28 days
|
Haemostasis is achieved when no bleeding of the wound site is actively seen.
|
28 days
|
|
Number of Participants With Haemostasis of Wound Area
기간: 45 days
|
Haemostasis is achieved when no bleeding of the wound site is actively seen.
|
45 days
|
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Number of Participants With Haemostasis of Wound Area
기간: 60 days
|
Haemostasis is achieved when no bleeding of the wound site is actively seen.
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60 days
|
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Pain as Assessed by a Visual Analogue Scale (VAS)
기간: baseline
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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.
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baseline
|
|
Pain as Assessed by a Visual Analogue Scale (VAS)
기간: 4 days
|
Pain will be assessed by a Visual Analogue Scale (VAS).
Scores range form 0 to 10. 0 indicates no pain, 1 indicates minimal pain, and 10 indicates severe pain.
|
4 days
|
|
Pain as Assessed by a Visual Analogue Scale (VAS)
기간: 10 days
|
Pain will be assessed by a Visual Analogue Scale (VAS).
Scores range form 0 to 10. 0 indicates no pain, 1 indicates minimal pain, and 10 indicates severe pain.
|
10 days
|
|
Pain as Assessed by a Visual Analogue Scale (VAS)
기간: 14 days
|
Pain will be assessed by a Visual Analogue Scale (VAS).
Scores range form 0 to 10. 0 indicates no pain, 1 indicates minimal pain, and 10 indicates severe pain.
|
14 days
|
|
Pain as Assessed by a Visual Analogue Scale (VAS)
기간: 21 days
|
Pain will be assessed by a Visual Analogue Scale (VAS).
Scores range form 0 to 10. 0 indicates no pain, 1 indicates minimal pain, and 10 indicates severe pain.
|
21 days
|
|
Pain as Assessed by a Visual Analogue Scale (VAS)
기간: 28 days
|
Pain will be assessed by a Visual Analogue Scale (VAS).
Scores range form 0 to 10. 0 indicates no pain, 1 indicates minimal pain, and 10 indicates severe pain.
|
28 days
|
|
Pain as Assessed by a Visual Analogue Scale (VAS)
기간: 45 days
|
Pain will be assessed by a Visual Analogue Scale (VAS).
Scores range form 0 to 10. 0 indicates no pain, 1 indicates minimal pain, and 10 indicates severe pain.
|
45 days
|
|
Pain as Assessed by a Visual Analogue Scale (VAS)
기간: 60 days
|
Pain will be assessed by a Visual Analogue Scale (VAS).
Scores range form 0 to 10. 0 indicates no pain, 1 indicates minimal pain, and 10 indicates severe pain.
|
60 days
|
|
Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS)
기간: 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.
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baseline
|
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Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS)
기간: 4 days
|
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.
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4 days
|
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Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS)
기간: 10 days
|
Sensibility will be assessed with a periodontal probe using a rubbing movement and pin-pressure nociception.
Patients will be asked to rate their sensibility based on a 3-point verbal descriptor scale (VDS): no loss of sensation, mild/moderate loss of sensation, or severe loss of sensation.
|
10 days
|
|
Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS)
기간: 14 days
|
Sensibility will be assessed with a periodontal probe using a rubbing movement and pin-pressure nociception.
Patients will be asked to rate their sensibility based on a 3-point verbal descriptor scale (VDS): no loss of sensation, mild/moderate loss of sensation, or severe loss of sensation.
|
14 days
|
|
Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS)
기간: 21 days
|
Sensibility will be assessed with a periodontal probe using a rubbing movement and pin-pressure nociception.
Patients will be asked to rate their sensibility based on a 3-point verbal descriptor scale (VDS): no loss of sensation, mild/moderate loss of sensation, or severe loss of sensation.
|
21 days
|
|
Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS)
기간: 28 days
|
Sensibility will be assessed with a periodontal probe using a rubbing movement and pin-pressure nociception.
Patients will be asked to rate their sensibility based on a 3-point verbal descriptor scale (VDS): no loss of sensation, mild/moderate loss of sensation, or severe loss of sensation.
|
28 days
|
|
Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS)
기간: 45 days
|
Sensibility will be assessed with a periodontal probe using a rubbing movement and pin-pressure nociception.
Patients will be asked to rate their sensibility based on a 3-point verbal descriptor scale (VDS): no loss of sensation, mild/moderate loss of sensation, or severe loss of sensation.
|
45 days
|
|
Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS)
기간: 60 days
|
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.
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60 days
|
|
Volume of Wound
기간: baseline
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The wound area will analyzed with an intraoral scanner, and three-dimensional images will be reconstructed to determine the volume of the wound.
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baseline
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Volume of Wound
기간: 4 days
|
The wound area will analyzed with an intraoral scanner, and three-dimensional images will be reconstructed to determine the volume of the wound.
|
4 days
|
|
Volume of Wound
기간: 10 days
|
The wound area will analyzed with an intraoral scanner, and three-dimensional images will be reconstructed to determine the volume of the wound.
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10 days
|
|
Volume of Wound
기간: 14 days
|
The wound area will analyzed with an intraoral scanner, and three-dimensional images will be reconstructed to determine the volume of the wound.
|
14 days
|
|
Volume of Wound
기간: 21 days
|
The wound area will analyzed with an intraoral scanner, and three-dimensional images will be reconstructed to determine the volume of the wound.
|
21 days
|
|
Volume of Wound
기간: 28 days
|
The wound area will analyzed with an intraoral scanner, and three-dimensional images will be reconstructed to determine the volume of the wound.
|
28 days
|
|
Volume of Wound
기간: 45 days
|
The wound area will analyzed with an intraoral scanner, and three-dimensional images will be reconstructed to determine the volume of the wound.
|
45 days
|
|
Volume of Wound
기간: 60 days
|
The wound area will analyzed with an intraoral scanner, and three-dimensional images will be reconstructed to determine the volume of the wound.
|
60 days
|
|
Clinician's Feedback on the Wound Dressing Material as Assessed by a Questionnaire
기간: at the time of placement of the wound dressing material
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at the time of placement of the wound dressing material
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Number of Neutrophil Cells as Assessed by Light Microscopy of Haematoxylin and Eosin (H&E)-Stained Biopsy Sections
기간: baseline
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Gingival specimen biopsies (4mm in diameter, 1.5mm in thickness) will be harvested.
The histological sections will be evaluated using a Nikon light microscope.
|
baseline
|
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Number of Neutrophil Cells as Assessed by Light Microscopy of Haematoxylin and Eosin (H&E)-Stained Biopsy Sections
기간: 10 days
|
Gingival specimen biopsies (4mm in diameter, 1.5mm in thickness) will be harvested.
The histological sections will be evaluated using a Nikon light microscope.
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10 days
|
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Change in Percentage of Collagen Density in Wound Area as Assessed by Light Microscopy of Masson's Trichrome-stained Biopsy Sections
기간: baseline, 10 days
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baseline, 10 days
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Thickness of the Epithelium as Assessed by Light Microscopy of Haematoxylin and Eosin (H&E)-Stained Biopsy Sections
기간: 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.
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baseline
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Thickness of the Epithelium as Assessed by Light Microscopy of Haematoxylin and Eosin (H&E)-Stained Biopsy Sections
기간: 10 days
|
Gingival specimen biopsies (4mm in diameter, 1.5mm in thickness) will be harvested.
The histological sections will be evaluated using a Nikon light microscope, and Nikon NIS-Elements Advanced Research (AR) Imagine Software will be used to calculate the thickness of the epithelium.
|
10 days
|
|
Angiogenesis as Indicated by Number of Blood Vessels as Assessed by Light Microscopy of Biopsy Sections Immunohistochemically Stained to Detect Factor VIII (Von Willebrandt Factor)
기간: baseline
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baseline
|
|
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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)
기간: 10 days
|
Gingival specimen biopsies (4mm in diameter, 1.5mm in thickness) will be harvested.
The histological sections will be evaluated using a Nikon light microscope, and the area of angiogenesis will be quantified using Nikon NIS Element AR Imagine Software.
|
10 days
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Chun-Teh Lee, The University of Texas Health Science Center, Houston
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2016년 10월 3일
기본 완료 (실제)
2020년 1월 17일
연구 완료 (실제)
2020년 1월 17일
연구 등록 날짜
최초 제출
2018년 10월 17일
QC 기준을 충족하는 최초 제출
2018년 10월 17일
처음 게시됨 (실제)
2018년 10월 19일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2022년 1월 19일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 12월 17일
마지막으로 확인됨
2021년 12월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- HSC-DB-18-0303
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
예
미국에서 제조되어 미국에서 수출되는 제품
아니
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구개 상처에 대한 임상 시험
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Technical University of Munich완전한수술 부위 감염 수 비교 | 승인된 Abdominal 3M™ Steri-Drape™ Wound Edge Protector 및 Standard Woven으로 개복술에서 복벽을 덮음 | 면봉독일