Clinical and Histological Outcomes of Allogenic Amnion Chorion Membrane in the Healing of Free Gingival Graft Donor Site
17 december 2021 uppdaterad av: 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).
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
19
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Texas
-
Houston, Texas, Förenta staterna, 77030
- The University of Texas Health Science Center at Houston
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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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Aktiv 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Size of Wound Area
Tidsram: 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
|
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Size of Wound Area
Tidsram: 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
|
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Size of Wound Area
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Number of Participants Stratified as Per the Degree of Epithelialization of Wound
Tidsram: 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
Tidsram: 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.
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4 days
|
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Number of Participants Stratified as Per the Degree of Epithelialization of Wound
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
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Number of Participants Stratified as Per the Degree of Epithelialization of Wound
Tidsram: 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
Tidsram: 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
Tidsram: 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.
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60 days
|
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Relative Difference in Color of Wound Site Compared to Adjacent Gingiva
Tidsram: 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
Tidsram: 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
Tidsram: 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.
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10 days
|
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Relative Difference in Color of Wound Site Compared to Adjacent Gingiva
Tidsram: 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
Tidsram: 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.
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21 days
|
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Relative Difference in Color of Wound Site Compared to Adjacent Gingiva
Tidsram: 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
Tidsram: 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
|
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Relative Difference in Color of Wound Site Compared to Adjacent Gingiva
Tidsram: 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
Tidsram: baseline
|
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
Tidsram: 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
Tidsram: 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
Tidsram: 14 days
|
Haemostasis is achieved when no bleeding of the wound site is actively seen.
|
14 days
|
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Number of Participants With Haemostasis of Wound Area
Tidsram: 21 days
|
Haemostasis is achieved when no bleeding of the wound site is actively seen.
|
21 days
|
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Number of Participants With Haemostasis of Wound Area
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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.
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baseline
|
|
Pain as Assessed by a Visual Analogue Scale (VAS)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
|
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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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
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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
Tidsram: 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
Tidsram: 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
|
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Thickness of the Epithelium as Assessed by Light Microscopy of Haematoxylin and Eosin (H&E)-Stained Biopsy Sections
Tidsram: 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
|
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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)
Tidsram: 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)
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Chun-Teh Lee, The University of Texas Health Science Center, Houston
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
3 oktober 2016
Primärt slutförande (Faktisk)
17 januari 2020
Avslutad studie (Faktisk)
17 januari 2020
Studieregistreringsdatum
Först inskickad
17 oktober 2018
Först inskickad som uppfyllde QC-kriterierna
17 oktober 2018
Första postat (Faktisk)
19 oktober 2018
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
19 januari 2022
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
17 december 2021
Senast verifierad
1 december 2021
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- HSC-DB-18-0303
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Ja
produkt tillverkad i och exporterad från U.S.A.
Nej
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