N/A
Completed N=19
Clinical and Histological Outcomes of Allogenic Amnion Chorion Membrane in the Healing of Free Gingival Graft Donor Site
Palatal Wound
Source: ClinicalTrials.gov NCT03713073 ↗
Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Jan 2022
Primary outcomePrimary: Size of Wound Area — 80; 80 micrometers (μm)
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 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 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 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 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 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 | — |
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
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. Informational only — not medical advice.