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

17 december 2021 bijgewerkt door: 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).

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

19

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Texas
      • Houston, Texas, Verenigde Staten, 77030
        • The University of Texas Health Science Center at Houston

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Apparaat: 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.
Actieve vergelijker: Collagen dressing
Collagen dressing is used to cover wounds in dental surgery.
Apparaat: Collagen dressing
Collagen dressing is used to cover wounds in dental surgery.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Size of Wound Area
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of Participants Stratified as Per the Degree of Epithelialization of Wound
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: baseline
Haemostasis is achieved when no bleeding of the wound site is actively seen.
baseline
Number of Participants With Haemostasis of Wound Area
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: baseline, 10 days
baseline, 10 days
Thickness of the Epithelium as Assessed by Light Microscopy of Haematoxylin and Eosin (H&E)-Stained Biopsy Sections
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

The University of Texas Health Science Center, Houston

Onderzoekers

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

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

3 oktober 2016

Primaire voltooiing (Werkelijk)

17 januari 2020

Studie voltooiing (Werkelijk)

17 januari 2020

Studieregistratiedata

Eerst ingediend

17 oktober 2018

Eerst ingediend dat voldeed aan de QC-criteria

17 oktober 2018

Eerst geplaatst (Werkelijk)

19 oktober 2018

Updates van studierecords

Laatste update geplaatst (Werkelijk)

19 januari 2022

Laatste update ingediend die voldeed aan QC-criteria

17 december 2021

Laatst geverifieerd

1 december 2021

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • HSC-DB-18-0303

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Ja

product vervaardigd in en geëxporteerd uit de V.S.

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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