Clinical and Histological Outcomes of Allogenic Amnion Chorion Membrane in the Healing of Free Gingival Graft Donor Site
17. Dezember 2021 aktualisiert von: 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).
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Tatsächlich)
19
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
Texas
-
Houston, Texas, Vereinigte Staaten, 77030
- The University of Texas Health Science Center at Houston
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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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Aktiver Komparator: 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Size of Wound Area
Zeitfenster: 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.
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baseline
|
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Size of Wound Area
Zeitfenster: 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
Zeitfenster: 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
|
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Size of Wound Area
Zeitfenster: 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
|
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Size of Wound Area
Zeitfenster: 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.
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21 days
|
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Size of Wound Area
Zeitfenster: 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
|
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Size of Wound Area
Zeitfenster: 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
|
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Size of Wound Area
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Number of Participants Stratified as Per the Degree of Epithelialization of Wound
Zeitfenster: 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.
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baseline
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Number of Participants Stratified as Per the Degree of Epithelialization of Wound
Zeitfenster: 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
Zeitfenster: 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.
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10 days
|
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Number of Participants Stratified as Per the Degree of Epithelialization of Wound
Zeitfenster: 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
Zeitfenster: 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.
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21 days
|
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Number of Participants Stratified as Per the Degree of Epithelialization of Wound
Zeitfenster: 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.
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28 days
|
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Number of Participants Stratified as Per the Degree of Epithelialization of Wound
Zeitfenster: 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.
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45 days
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Number of Participants Stratified as Per the Degree of Epithelialization of Wound
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 14 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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14 days
|
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Relative Difference in Color of Wound Site Compared to Adjacent Gingiva
Zeitfenster: 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
Zeitfenster: 28 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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28 days
|
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Relative Difference in Color of Wound Site Compared to Adjacent Gingiva
Zeitfenster: 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
Zeitfenster: 60 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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60 days
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Number of Participants With Haemostasis of Wound Area
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 10 days
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Haemostasis is achieved when no bleeding of the wound site is actively seen.
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10 days
|
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Number of Participants With Haemostasis of Wound Area
Zeitfenster: 14 days
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Haemostasis is achieved when no bleeding of the wound site is actively seen.
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14 days
|
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Number of Participants With Haemostasis of Wound Area
Zeitfenster: 21 days
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Haemostasis is achieved when no bleeding of the wound site is actively seen.
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21 days
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Number of Participants With Haemostasis of Wound Area
Zeitfenster: 28 days
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Haemostasis is achieved when no bleeding of the wound site is actively seen.
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28 days
|
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Number of Participants With Haemostasis of Wound Area
Zeitfenster: 45 days
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Haemostasis is achieved when no bleeding of the wound site is actively seen.
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45 days
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Number of Participants With Haemostasis of Wound Area
Zeitfenster: 60 days
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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)
Zeitfenster: 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
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Pain as Assessed by a Visual Analogue Scale (VAS)
Zeitfenster: 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.
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4 days
|
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Pain as Assessed by a Visual Analogue Scale (VAS)
Zeitfenster: 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.
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10 days
|
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Pain as Assessed by a Visual Analogue Scale (VAS)
Zeitfenster: 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.
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14 days
|
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Pain as Assessed by a Visual Analogue Scale (VAS)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
|
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Pain as Assessed by a Visual Analogue Scale (VAS)
Zeitfenster: 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.
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60 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)
Zeitfenster: baseline
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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)
Zeitfenster: 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)
Zeitfenster: 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.
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10 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)
Zeitfenster: 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.
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14 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
|
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Volume of Wound
Zeitfenster: 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
Zeitfenster: 4 days
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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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4 days
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Volume of Wound
Zeitfenster: 10 days
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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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10 days
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Volume of Wound
Zeitfenster: 14 days
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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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14 days
|
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Volume of Wound
Zeitfenster: 21 days
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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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21 days
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Volume of Wound
Zeitfenster: 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
Zeitfenster: 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.
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45 days
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Volume of Wound
Zeitfenster: 60 days
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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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60 days
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Clinician's Feedback on the Wound Dressing Material as Assessed by a Questionnaire
Zeitfenster: 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
Zeitfenster: 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.
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baseline
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Number of Neutrophil Cells as Assessed by Light Microscopy of Haematoxylin and Eosin (H&E)-Stained Biopsy Sections
Zeitfenster: 10 days
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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.
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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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.
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10 days
|
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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)
Zeitfenster: 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)
Zeitfenster: 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.
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10 days
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Ermittler
- Hauptermittler: Chun-Teh Lee, The University of Texas Health Science Center, Houston
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
3. Oktober 2016
Primärer Abschluss (Tatsächlich)
17. Januar 2020
Studienabschluss (Tatsächlich)
17. Januar 2020
Studienanmeldedaten
Zuerst eingereicht
17. Oktober 2018
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
17. Oktober 2018
Zuerst gepostet (Tatsächlich)
19. Oktober 2018
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
19. Januar 2022
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
17. Dezember 2021
Zuletzt verifiziert
1. Dezember 2021
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- HSC-DB-18-0303
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Ja
Produkt, das in den USA hergestellt und aus den USA exportiert wird
Nein
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