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Clinical and Histological Outcomes of Allogenic Amnion Chorion Membrane in the Healing of Free Gingival Graft Donor Site

17. prosince 2021 aktualizováno: 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).

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

19

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Spojené státy
    • Texas
      • Houston, Texas, Spojené státy, 77030
        • The University of Texas Health Science Center at Houston

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Přístroj: 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.
Aktivní komparátor: Collagen dressing
Collagen dressing is used to cover wounds in dental surgery.
Přístroj: Collagen dressing
Collagen dressing is used to cover wounds in dental surgery.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Size of Wound Area
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Number of Participants Stratified as Per the Degree of Epithelialization of Wound
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Relative Difference in Color of Wound Site Compared to Adjacent Gingiva
Časové okno: 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.
4 days
Relative Difference in Color of Wound Site Compared to Adjacent Gingiva
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: baseline
Haemostasis is achieved when no bleeding of the wound site is actively seen.
baseline
Number of Participants With Haemostasis of Wound Area
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: baseline, 10 days
baseline, 10 days
Thickness of the Epithelium as Assessed by Light Microscopy of Haematoxylin and Eosin (H&E)-Stained Biopsy Sections
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

The University of Texas Health Science Center, Houston

Vyšetřovatelé

  • Vrchní vyšetřovatel: Chun-Teh Lee, The University of Texas Health Science Center, Houston

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

3. října 2016

Primární dokončení (Aktuální)

17. ledna 2020

Dokončení studie (Aktuální)

17. ledna 2020

Termíny zápisu do studia

První předloženo

17. října 2018

První předloženo, které splnilo kritéria kontroly kvality

17. října 2018

První zveřejněno (Aktuální)

19. října 2018

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

19. ledna 2022

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

17. prosince 2021

Naposledy ověřeno

1. prosince 2021

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • HSC-DB-18-0303

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ano

produkt vyrobený a vyvážený z USA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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