Clinical trial NCT03713073: Clinical and Histological Outcomes of Allogenic Amnion Chorion Membrane in the Healing of Free Gingival Graft Donor Site
Official title: Clinical and Histological Outcomes of Allogenic Amnion Chorion Membrane in the Healing of Free Gingival Graft Donor Site
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Palatal Wound
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2018-10-19
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is a "split-mouth design," in which two treatments (test and control) are randomly assigned to either the right or left halves of the dentition/palate.
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: 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

Primary outcomes:
measure: Size of Wound Area
timeFrame: baseline
measure: Size of Wound Area
timeFrame: 4 days
measure: Size of Wound Area
timeFrame: 10 days
measure: Size of Wound Area
timeFrame: 14 days
measure: Size of Wound Area
timeFrame: 21 days
measure: Size of Wound Area
timeFrame: 28 days
measure: Size of Wound Area
timeFrame: 45 days
measure: Size of Wound Area
timeFrame: 60 days
Secondary outcomes:
measure: Number of Participants Stratified as Per the Degree of Epithelialization of Wound
timeFrame: baseline
measure: Number of Participants Stratified as Per the Degree of Epithelialization of Wound
timeFrame: 4 days
measure: Number of Participants Stratified as Per the Degree of Epithelialization of Wound
timeFrame: 10 days
measure: Number of Participants Stratified as Per the Degree of Epithelialization of Wound
timeFrame: 14 days
measure: Number of Participants Stratified as Per the Degree of Epithelialization of Wound
timeFrame: 21 days
measure: Number of Participants Stratified as Per the Degree of Epithelialization of Wound
timeFrame: 28 days
measure: Number of Participants Stratified as Per the Degree of Epithelialization of Wound
timeFrame: 45 days
measure: Number of Participants Stratified as Per the Degree of Epithelialization of Wound
timeFrame: 60 days
measure: Relative Difference in Color of Wound Site Compared to Adjacent Gingiva
timeFrame: baseline
measure: Relative Difference in Color of Wound Site Compared to Adjacent Gingiva
timeFrame: 4 days
measure: Relative Difference in Color of Wound Site Compared to Adjacent Gingiva
timeFrame: 10 days
measure: Relative Difference in Color of Wound Site Compared to Adjacent Gingiva
timeFrame: 14 days
measure: Relative Difference in Color of Wound Site Compared to Adjacent Gingiva
timeFrame: 21 days
measure: Relative Difference in Color of Wound Site Compared to Adjacent Gingiva
timeFrame: 28 days
measure: Relative Difference in Color of Wound Site Compared to Adjacent Gingiva
timeFrame: 45 days
measure: Relative Difference in Color of Wound Site Compared to Adjacent Gingiva
timeFrame: 60 days
measure: Number of Participants With Haemostasis of Wound Area
timeFrame: baseline
measure: Number of Participants With Haemostasis of Wound Area
timeFrame: 4 days
measure: Number of Participants With Haemostasis of Wound Area
timeFrame: 10 days
measure: Number of Participants With Haemostasis of Wound Area
timeFrame: 14 days
measure: Number of Participants With Haemostasis of Wound Area
timeFrame: 21 days
measure: Number of Participants With Haemostasis of Wound Area
timeFrame: 28 days
measure: Number of Participants With Haemostasis of Wound Area
timeFrame: 45 days
measure: Number of Participants With Haemostasis of Wound Area
timeFrame: 60 days
measure: Pain as Assessed by a Visual Analogue Scale (VAS)
timeFrame: baseline
measure: Pain as Assessed by a Visual Analogue Scale (VAS)
timeFrame: 4 days
measure: Pain as Assessed by a Visual Analogue Scale (VAS)
timeFrame: 10 days
measure: Pain as Assessed by a Visual Analogue Scale (VAS)
timeFrame: 14 days
measure: Pain as Assessed by a Visual Analogue Scale (VAS)
timeFrame: 21 days
measure: Pain as Assessed by a Visual Analogue Scale (VAS)
timeFrame: 28 days
measure: Pain as Assessed by a Visual Analogue Scale (VAS)
timeFrame: 45 days
measure: Pain as Assessed by a Visual Analogue Scale (VAS)
timeFrame: 60 days
measure: Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS)
timeFrame: baseline
measure: Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS)
timeFrame: 4 days
measure: Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS)
timeFrame: 10 days
measure: Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS)
timeFrame: 14 days
measure: Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS)
timeFrame: 21 days
measure: Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS)
timeFrame: 28 days
measure: Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS)
timeFrame: 45 days
measure: Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS)
timeFrame: 60 days
measure: Volume of Wound
timeFrame: baseline
measure: Volume of Wound
timeFrame: 4 days
measure: Volume of Wound
timeFrame: 10 days
measure: Volume of Wound
timeFrame: 14 days
measure: Volume of Wound
timeFrame: 21 days
measure: Volume of Wound
timeFrame: 28 days
measure: Volume of Wound
timeFrame: 45 days
measure: Volume of Wound
timeFrame: 60 days
measure: Clinician's Feedback on the Wound Dressing Material as Assessed by a Questionnaire
timeFrame: at the time of placement of the wound dressing material
measure: Number of Neutrophil Cells as Assessed by Light Microscopy of Haematoxylin and Eosin (H&E)-Stained Biopsy Sections
timeFrame: baseline
measure: Number of Neutrophil Cells as Assessed by Light Microscopy of Haematoxylin and Eosin (H&E)-Stained Biopsy Sections
timeFrame: 10 days
measure: Change in Percentage of Collagen Density in Wound Area as Assessed by Light Microscopy of Masson's Trichrome-stained Biopsy Sections
timeFrame: baseline, 10 days
measure: Thickness of the Epithelium as Assessed by Light Microscopy of Haematoxylin and Eosin (H&E)-Stained Biopsy Sections
timeFrame: baseline
measure: Thickness of the Epithelium as Assessed by Light Microscopy of Haematoxylin and Eosin (H&E)-Stained Biopsy Sections
timeFrame: 10 days
measure: 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)
timeFrame: baseline
measure: 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)
timeFrame: 10 days
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Chun-Teh Lee
role: PRINCIPAL_INVESTIGATOR
References: