N/A N=19 Randomized Single-blind Treatment

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

Palatal Wound

Bottom Line

View on ClinicalTrials.gov: NCT03713073 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2022

Primary outcome: Primary: Size of Wound Area — 80; 80 micrometers (μm)

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Allogenic amnion chorion membrane (Device); Collagen dressing (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: The University of Texas Health Science Center, Houston
Primary completion: Jan 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Size of Wound Area	0; 0	—
PRIMARY Size of Wound Area	0; 0	—
PRIMARY Size of Wound Area	0; 0	—
PRIMARY Size of Wound Area	0; 0	—
PRIMARY Size of Wound Area	0; 0	—
PRIMARY Size of Wound Area	0; 0	—
PRIMARY Size of Wound Area	0; 0	—
PRIMARY Size of Wound Area	0; 0	—
SECONDARY Number of Participants Stratified as Per the Degree of Epithelialization of Wound	0; 0; 0; 0; 19; 19	—
SECONDARY Number of Participants Stratified as Per the Degree of Epithelialization of Wound	0; 0; 0; 0; 19; 19	—
SECONDARY Number of Participants Stratified as Per the Degree of Epithelialization of Wound	0; 0; 0; 0; 19; 19	—
SECONDARY Number of Participants Stratified as Per the Degree of Epithelialization of Wound	0; 0; 0; 0; 19; 19	—
SECONDARY Number of Participants Stratified as Per the Degree of Epithelialization of Wound	0; 0; 0; 0; 19; 19	—
SECONDARY Number of Participants Stratified as Per the Degree of Epithelialization of Wound	0; 0; 0; 0; 19; 19	—
SECONDARY Number of Participants Stratified as Per the Degree of Epithelialization of Wound	0; 0; 0; 0; 19; 19	—
SECONDARY Number of Participants Stratified as Per the Degree of Epithelialization of Wound	0; 0; 0; 0; 19; 19	—
SECONDARY Relative Difference in Color of Wound Site Compared to Adjacent Gingiva	0; 0; 0; 0; 2; 3	—
SECONDARY Relative Difference in Color of Wound Site Compared to Adjacent Gingiva	0; 0; 0; 0; 2; 3	—
SECONDARY Relative Difference in Color of Wound Site Compared to Adjacent Gingiva	0; 0; 0; 0; 2; 3	—
SECONDARY Relative Difference in Color of Wound Site Compared to Adjacent Gingiva	0; 0; 0; 0; 2; 3	—
SECONDARY Relative Difference in Color of Wound Site Compared to Adjacent Gingiva	0; 0; 0; 0; 2; 3	—
SECONDARY Relative Difference in Color of Wound Site Compared to Adjacent Gingiva	0; 0; 0; 0; 2; 3	—
SECONDARY Relative Difference in Color of Wound Site Compared to Adjacent Gingiva	0; 0; 0; 0; 2; 3	—
SECONDARY Relative Difference in Color of Wound Site Compared to Adjacent Gingiva	0; 0; 0; 0; 2; 3	—
SECONDARY Number of Participants With Haemostasis of Wound Area	19; 19	—
SECONDARY Number of Participants With Haemostasis of Wound Area	19; 19	—
SECONDARY Number of Participants With Haemostasis of Wound Area	19; 19	—
SECONDARY Number of Participants With Haemostasis of Wound Area	19; 19	—
SECONDARY Number of Participants With Haemostasis of Wound Area	19; 19	—
SECONDARY Number of Participants With Haemostasis of Wound Area	19; 19	—
SECONDARY Number of Participants With Haemostasis of Wound Area	19; 19	—
SECONDARY Number of Participants With Haemostasis of Wound Area	19; 19	—
SECONDARY Pain as Assessed by a Visual Analogue Scale (VAS)	0; 0	—
SECONDARY Pain as Assessed by a Visual Analogue Scale (VAS)	0; 0	—
SECONDARY Pain as Assessed by a Visual Analogue Scale (VAS)	0; 0	—
SECONDARY Pain as Assessed by a Visual Analogue Scale (VAS)	0; 0	—
SECONDARY Pain as Assessed by a Visual Analogue Scale (VAS)	0; 0	—
SECONDARY Pain as Assessed by a Visual Analogue Scale (VAS)	0; 0	—
SECONDARY Pain as Assessed by a Visual Analogue Scale (VAS)	0; 0	—
SECONDARY Pain as Assessed by a Visual Analogue Scale (VAS)	0; 0	—
SECONDARY Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS)	19; 19; 0; 0; 0; 0	—
SECONDARY Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS)	19; 19; 0; 0; 0; 0	—
SECONDARY Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS)	19; 19; 0; 0; 0; 0	—
SECONDARY Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS)	19; 19; 0; 0; 0; 0	—
SECONDARY Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS)	19; 19; 0; 0; 0; 0	—
SECONDARY Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS)	19; 19; 0; 0; 0; 0	—
SECONDARY Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS)	19; 19; 0; 0; 0; 0	—
SECONDARY Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS)	19; 19; 0; 0; 0; 0	—
SECONDARY Volume of Wound	—	—
SECONDARY Volume of Wound	—	—
SECONDARY Volume of Wound	—	—
SECONDARY Volume of Wound	—	—
SECONDARY Volume of Wound	—	—
SECONDARY Volume of Wound	—	—
SECONDARY Volume of Wound	—	—
SECONDARY Volume of Wound	—	—
SECONDARY Clinician's Feedback on the Wound Dressing Material as Assessed by a Questionnaire	—	—
SECONDARY Number of Neutrophil Cells as Assessed by Light Microscopy of Haematoxylin and Eosin (H&E)-Stained Biopsy Sections	80; 88	—
SECONDARY Number of Neutrophil Cells as Assessed by Light Microscopy of Haematoxylin and Eosin (H&E)-Stained Biopsy Sections	80; 88	—
SECONDARY Change in Percentage of Collagen Density in Wound Area as Assessed by Light Microscopy of Masson's Trichrome-stained Biopsy Sections	1.15; 3.38	—
SECONDARY Thickness of the Epithelium as Assessed by Light Microscopy of Haematoxylin and Eosin (H&E)-Stained Biopsy Sections	339.6; 339.3	—
SECONDARY Thickness of the Epithelium as Assessed by Light Microscopy of Haematoxylin and Eosin (H&E)-Stained Biopsy Sections	339.6; 339.3	—
SECONDARY 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)	4.4; 5.1	—
SECONDARY 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)	4.4; 5.1	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03713073). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.