Clinical and Histological Outcomes of Allogenic Amnion Chorion Membrane in the Healing of Free Gingival Graft Donor Site
2021年12月17日 更新者：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).
調査の概要
研究の種類
介入
入学 (実際)
19
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Texas
-
Houston、Texas、アメリカ、77030
- The University of Texas Health Science Center at Houston
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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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アクティブコンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Size of Wound Area
時間枠：baseline
|
The wound area will be assessed by means of a clinical picture.
The picture will be taken with an angulation perpendicular to the wound.
A periodontal probe will be placed by the wound as a reference scale.
Wound area is defined as the area without epithelization.
The wound area on the picture will be measured by ImageJ.
|
baseline
|
|
Size of Wound Area
時間枠：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.
|
4 days
|
|
Size of Wound Area
時間枠：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.
|
10 days
|
|
Size of Wound Area
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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.
|
60 days
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of Participants Stratified as Per the Degree of Epithelialization of Wound
時間枠：baseline
|
Epithelialization is measured by means of bubble formation after dripping hydrogen peroxide (3%) to the wound surface.
Less bubbles indicate greater epithelialization, and epithelialization will be ranked as total, partial or none.
|
baseline
|
|
Number of Participants Stratified as Per the Degree of Epithelialization of Wound
時間枠：4 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.
|
4 days
|
|
Number of Participants Stratified as Per the Degree of Epithelialization of Wound
時間枠：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
|
|
Number of Participants Stratified as Per the Degree of Epithelialization of Wound
時間枠：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.
|
14 days
|
|
Number of Participants Stratified as Per the Degree of Epithelialization of Wound
時間枠：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
時間枠：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
|
|
Number of Participants Stratified as Per the Degree of Epithelialization of Wound
時間枠：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
|
|
Number of Participants Stratified as Per the Degree of Epithelialization of Wound
時間枠：60 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.
|
60 days
|
|
Relative Difference in Color of Wound Site Compared to Adjacent Gingiva
時間枠：baseline
|
The color of wound site will be compared to the adjacent gingiva by using a 4-point scale: 1. Obvious difference; 2. Noticeable difference; 3. Disguisable difference; or 4. No noticeable difference in comparison with adjacent gingiva.
|
baseline
|
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Relative Difference in Color of Wound Site Compared to Adjacent Gingiva
時間枠：4 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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4 days
|
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Relative Difference in Color of Wound Site Compared to Adjacent Gingiva
時間枠：10 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.
|
10 days
|
|
Relative Difference in Color of Wound Site Compared to Adjacent Gingiva
時間枠：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.
|
14 days
|
|
Relative Difference in Color of Wound Site Compared to Adjacent Gingiva
時間枠：21 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.
|
21 days
|
|
Relative Difference in Color of Wound Site Compared to Adjacent Gingiva
時間枠：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.
|
28 days
|
|
Relative Difference in Color of Wound Site Compared to Adjacent Gingiva
時間枠：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.
|
45 days
|
|
Relative Difference in Color of Wound Site Compared to Adjacent Gingiva
時間枠：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.
|
60 days
|
|
Number of Participants With Haemostasis of Wound Area
時間枠：baseline
|
Haemostasis is achieved when no bleeding of the wound site is actively seen.
|
baseline
|
|
Number of Participants With Haemostasis of Wound Area
時間枠：4 days
|
Haemostasis is achieved when no bleeding of the wound site is actively seen.
|
4 days
|
|
Number of Participants With Haemostasis of Wound Area
時間枠：10 days
|
Haemostasis is achieved when no bleeding of the wound site is actively seen.
|
10 days
|
|
Number of Participants With Haemostasis of Wound Area
時間枠：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
時間枠：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
時間枠：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
時間枠：45 days
|
Haemostasis is achieved when no bleeding of the wound site is actively seen.
|
45 days
|
|
Number of Participants With Haemostasis of Wound Area
時間枠：60 days
|
Haemostasis is achieved when no bleeding of the wound site is actively seen.
|
60 days
|
|
Pain as Assessed by a Visual Analogue Scale (VAS)
時間枠：baseline
|
Pain will be assessed by a Visual Analogue Scale (VAS).
Scores range form 0 to 10. 0 indicates no pain, 1 indicates minimal pain, and 10 indicates severe pain.
|
baseline
|
|
Pain as Assessed by a Visual Analogue Scale (VAS)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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.
|
baseline
|
|
Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS)
時間枠：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.
|
4 days
|
|
Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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.
|
60 days
|
|
Volume of Wound
時間枠：baseline
|
The wound area will analyzed with an intraoral scanner, and three-dimensional images will be reconstructed to determine the volume of the wound.
|
baseline
|
|
Volume of Wound
時間枠：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
時間枠：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.
|
10 days
|
|
Volume of Wound
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：at the time of placement of the wound dressing material
|
at the time of placement of the wound dressing material
|
|
|
Number of Neutrophil Cells as Assessed by Light Microscopy of Haematoxylin and Eosin (H&E)-Stained Biopsy Sections
時間枠：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.
|
baseline
|
|
Number of Neutrophil Cells as Assessed by Light Microscopy of Haematoxylin and Eosin (H&E)-Stained Biopsy Sections
時間枠：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.
|
10 days
|
|
Change in Percentage of Collagen Density in Wound Area as Assessed by Light Microscopy of Masson's Trichrome-stained Biopsy Sections
時間枠：baseline, 10 days
|
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
時間枠：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.
|
baseline
|
|
Thickness of the Epithelium as Assessed by Light Microscopy of Haematoxylin and Eosin (H&E)-Stained Biopsy Sections
時間枠：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)
時間枠：baseline
|
baseline
|
|
|
Angiogenesis as Indicated by Number of Blood Vessels as Assessed by Light Microscopy of Biopsy Sections Immunohistochemically Stained to Detect Factor VIII (Von Willebrandt Factor)
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Chun-Teh Lee、The University of Texas Health Science Center, Houston
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2016年10月3日
一次修了 (実際)
2020年1月17日
研究の完了 (実際)
2020年1月17日
試験登録日
最初に提出
2018年10月17日
QC基準を満たした最初の提出物
2018年10月17日
最初の投稿 (実際)
2018年10月19日
学習記録の更新
投稿された最後の更新 (実際)
2022年1月19日
QC基準を満たした最後の更新が送信されました
2021年12月17日
最終確認日
2021年12月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- HSC-DB-18-0303
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
はい
米国で製造され、米国から輸出された製品。
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。